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Glama

Constat MCP — FDA Device Evidence Lifecycle

by com.healthai

Server Details

FDA and CMS evidence for AI medical devices: 510(k), postmarket, reimbursement, and compliance.

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Unhealthy
Last Tested
Transport
Streamable HTTP
URL
Server Listing
Constat — 483 Risk Radar

Tool Schema Changelog

Recent tool additions, removals, and schema changes observed during successful MCP inspections. Dates show when Glama detected each change.

  1. 14 tool updates
    • Changedcohort_postmarket_stats1 field changed
      • changedOutput schema / (root)
        Previous value: -nullNew value: +{
+  "$schema": "http://json-schema.org/draft-07/schema#",
+  "additionalProperties": false,
+  "properties": {
+    "data": {
+      "anyOf": [
+        {},
+        {
+          "type": "null"
+        }
+      ]
+    },
+    "message": {
+      "type": "string"
+    },
+    "status": {
+      "enum": [
+        "ok",
+        "not_found",
+        "invalid_request",
+        "unavailable"
+      ],
+      "type": "string"
+    }
+  },
+  "required": [
+    "status",
+    "data"
+  ],
+  "type": "object"
+}
    • Changeddevice_evidence_lookup1 field changed
      • changedOutput schema / (root)
        Previous value: -nullNew value: +{
+  "$schema": "http://json-schema.org/draft-07/schema#",
+  "additionalProperties": false,
+  "properties": {
+    "data": {
+      "anyOf": [
+        {},
+        {
+          "type": "null"
+        }
+      ]
+    },
+    "message": {
+      "type": "string"
+    },
+    "status": {
+      "enum": [
+        "ok",
+        "not_found",
+        "invalid_request",
+        "unavailable"
+      ],
+      "type": "string"
+    }
+  },
+  "required": [
+    "status",
+    "data"
+  ],
+  "type": "object"
+}
    • Changeddevice_postmarket_lookup1 field changed
      • changedOutput schema / (root)
        Previous value: -nullNew value: +{
+  "$schema": "http://json-schema.org/draft-07/schema#",
+  "additionalProperties": false,
+  "properties": {
+    "data": {
+      "anyOf": [
+        {},
+        {
+          "type": "null"
+        }
+      ]
+    },
+    "message": {
+      "type": "string"
+    },
+    "status": {
+      "enum": [
+        "ok",
+        "not_found",
+        "invalid_request",
+        "unavailable"
+      ],
+      "type": "string"
+    }
+  },
+  "required": [
+    "status",
+    "data"
+  ],
+  "type": "object"
+}
    • Changeddevice_risk_lookup1 field changed
      • changedOutput schema / (root)
        Previous value: -nullNew value: +{
+  "$schema": "http://json-schema.org/draft-07/schema#",
+  "additionalProperties": false,
+  "properties": {
+    "data": {
+      "anyOf": [
+        {},
+        {
+          "type": "null"
+        }
+      ]
+    },
+    "message": {
+      "type": "string"
+    },
+    "status": {
+      "enum": [
+        "ok",
+        "not_found",
+        "invalid_request",
+        "unavailable"
+      ],
+      "type": "string"
+    }
+  },
+  "required": [
+    "status",
+    "data"
+  ],
+  "type": "object"
+}
    • Changedevidence_cohort_stats1 field changed
      • changedOutput schema / (root)
        Previous value: -nullNew value: +{
+  "$schema": "http://json-schema.org/draft-07/schema#",
+  "additionalProperties": false,
+  "properties": {
+    "data": {
+      "anyOf": [
+        {},
+        {
+          "type": "null"
+        }
+      ]
+    },
+    "message": {
+      "type": "string"
+    },
+    "status": {
+      "enum": [
+        "ok",
+        "not_found",
+        "invalid_request",
+        "unavailable"
+      ],
+      "type": "string"
+    }
+  },
+  "required": [
+    "status",
+    "data"
+  ],
+  "type": "object"
+}
    • Changedevidence_search1 field changed
      • changedOutput schema / (root)
        Previous value: -nullNew value: +{
+  "$schema": "http://json-schema.org/draft-07/schema#",
+  "additionalProperties": false,
+  "properties": {
+    "data": {
+      "anyOf": [
+        {
+          "additionalProperties": false,
+          "properties": {
+            "count": {
+              "maximum": 9007199254740991,
+              "minimum": 0,
+              "type": "integer"
+            },
+            "results": {
+              "items": {},
+              "type": "array"
+            }
+          },
+          "required": [
+            "count",
+            "results"
+          ],
+          "type": "object"
+        },
+        {
+          "type": "null"
+        }
+      ]
+    },
+    "message": {
+      "type": "string"
+    },
+    "status": {
+      "enum": [
+        "ok",
+        "not_found",
+        "invalid_request",
+        "unavailable"
+      ],
+      "type": "string"
+    }
+  },
+  "required": [
+    "status",
+    "data"
+  ],
+  "type": "object"
+}
    • Changedfirm_compliance_history1 field changed
      • changedOutput schema / (root)
        Previous value: -nullNew value: +{
+  "$schema": "http://json-schema.org/draft-07/schema#",
+  "additionalProperties": false,
+  "properties": {
+    "data": {
+      "anyOf": [
+        {},
+        {
+          "type": "null"
+        }
+      ]
+    },
+    "message": {
+      "type": "string"
+    },
+    "status": {
+      "enum": [
+        "ok",
+        "not_found",
+        "invalid_request",
+        "unavailable"
+      ],
+      "type": "string"
+    }
+  },
+  "required": [
+    "status",
+    "data"
+  ],
+  "type": "object"
+}
    • Changedpostmarket_search1 field changed
      • changedOutput schema / (root)
        Previous value: -nullNew value: +{
+  "$schema": "http://json-schema.org/draft-07/schema#",
+  "additionalProperties": false,
+  "properties": {
+    "data": {
+      "anyOf": [
+        {
+          "additionalProperties": false,
+          "properties": {
+            "count": {
+              "maximum": 9007199254740991,
+              "minimum": 0,
+              "type": "integer"
+            },
+            "results": {
+              "items": {},
+              "type": "array"
+            }
+          },
+          "required": [
+            "count",
+            "results"
+          ],
+          "type": "object"
+        },
+        {
+          "type": "null"
+        }
+      ]
+    },
+    "message": {
+      "type": "string"
+    },
+    "status": {
+      "enum": [
+        "ok",
+        "not_found",
+        "invalid_request",
+        "unavailable"
+      ],
+      "type": "string"
+    }
+  },
+  "required": [
+    "status",
+    "data"
+  ],
+  "type": "object"
+}
    • Changedpredicate_chain1 field changed
      • changedOutput schema / (root)
        Previous value: -nullNew value: +{
+  "$schema": "http://json-schema.org/draft-07/schema#",
+  "additionalProperties": false,
+  "properties": {
+    "data": {
+      "anyOf": [
+        {
+          "additionalProperties": false,
+          "properties": {
+            "chain": {
+              "items": {},
+              "type": "array"
+            },
+            "root": {
+              "type": "string"
+            }
+          },
+          "required": [
+            "root",
+            "chain"
+          ],
+          "type": "object"
+        },
+        {
+          "type": "null"
+        }
+      ]
+    },
+    "message": {
+      "type": "string"
+    },
+    "status": {
+      "enum": [
+        "ok",
+        "not_found",
+        "invalid_request",
+        "unavailable"
+      ],
+      "type": "string"
+    }
+  },
+  "required": [
+    "status",
+    "data"
+  ],
+  "type": "object"
+}
    • Changedreimbursement_lookup1 field changed
      • changedOutput schema / (root)
        Previous value: -nullNew value: +{
+  "$schema": "http://json-schema.org/draft-07/schema#",
+  "additionalProperties": false,
+  "properties": {
+    "data": {
+      "anyOf": [
+        {},
+        {
+          "type": "null"
+        }
+      ]
+    },
+    "message": {
+      "type": "string"
+    },
+    "status": {
+      "enum": [
+        "ok",
+        "not_found",
+        "invalid_request",
+        "unavailable"
+      ],
+      "type": "string"
+    }
+  },
+  "required": [
+    "status",
+    "data"
+  ],
+  "type": "object"
+}
    • Changedreimbursement_search1 field changed
      • changedOutput schema / (root)
        Previous value: -nullNew value: +{
+  "$schema": "http://json-schema.org/draft-07/schema#",
+  "additionalProperties": false,
+  "properties": {
+    "data": {
+      "anyOf": [
+        {
+          "additionalProperties": false,
+          "properties": {
+            "count": {
+              "maximum": 9007199254740991,
+              "minimum": 0,
+              "type": "integer"
+            },
+            "results": {
+              "items": {},
+              "type": "array"
+            }
+          },
+          "required": [
+            "count",
+            "results"
+          ],
+          "type": "object"
+        },
+        {
+          "type": "null"
+        }
+      ]
+    },
+    "message": {
+      "type": "string"
+    },
+    "status": {
+      "enum": [
+        "ok",
+        "not_found",
+        "invalid_request",
+        "unavailable"
+      ],
+      "type": "string"
+    }
+  },
+  "required": [
+    "status",
+    "data"
+  ],
+  "type": "object"
+}
    • Changedreimbursement_stats1 field changed
      • changedOutput schema / (root)
        Previous value: -nullNew value: +{
+  "$schema": "http://json-schema.org/draft-07/schema#",
+  "additionalProperties": false,
+  "properties": {
+    "data": {
+      "anyOf": [
+        {},
+        {
+          "type": "null"
+        }
+      ]
+    },
+    "message": {
+      "type": "string"
+    },
+    "status": {
+      "enum": [
+        "ok",
+        "not_found",
+        "invalid_request",
+        "unavailable"
+      ],
+      "type": "string"
+    }
+  },
+  "required": [
+    "status",
+    "data"
+  ],
+  "type": "object"
+}
    • Changedvehicle_risk_lookup1 field changed
      • changedOutput schema / (root)
        Previous value: -nullNew value: +{
+  "$schema": "http://json-schema.org/draft-07/schema#",
+  "additionalProperties": false,
+  "properties": {
+    "data": {
+      "anyOf": [
+        {},
+        {
+          "type": "null"
+        }
+      ]
+    },
+    "message": {
+      "type": "string"
+    },
+    "status": {
+      "enum": [
+        "ok",
+        "not_found",
+        "invalid_request",
+        "unavailable"
+      ],
+      "type": "string"
+    }
+  },
+  "required": [
+    "status",
+    "data"
+  ],
+  "type": "object"
+}
    • Changedwatchlist_diff1 field changed
      • changedOutput schema / (root)
        Previous value: -nullNew value: +{
+  "$schema": "http://json-schema.org/draft-07/schema#",
+  "additionalProperties": false,
+  "properties": {
+    "data": {
+      "anyOf": [
+        {},
+        {
+          "type": "null"
+        }
+      ]
+    },
+    "message": {
+      "type": "string"
+    },
+    "status": {
+      "enum": [
+        "ok",
+        "not_found",
+        "invalid_request",
+        "unavailable"
+      ],
+      "type": "string"
+    }
+  },
+  "required": [
+    "status",
+    "data"
+  ],
+  "type": "object"
+}
  2. 14 tool updates
    • Changedcohort_postmarket_stats3 fields changed
      • addedInput schema / $schema
        Added value: +"http://json-schema.org/draft-07/schema#"
      • removedInput schema / additionalProperties
        Removed value: -true
      • addedInput schema / properties
        Added value: +{
+  "panel": {
+    "description": "Advisory panel, e.g. Radiology; omit for all",
+    "type": "string"
+  }
+}
    • Changeddevice_evidence_lookup4 fields changed
      • addedInput schema / $schema
        Added value: +"http://json-schema.org/draft-07/schema#"
      • removedInput schema / additionalProperties
        Removed value: -true
      • addedInput schema / properties
        Added value: +{
+  "k_number": {
+    "description": "510(k) or De Novo number, e.g. K252148 or DEN180001",
+    "pattern": "^(K|DEN)\\d{6}$",
+    "type": "string"
+  }
+}
      • addedInput schema / required
        Added value: +[
+  "k_number"
+]
    • Changeddevice_postmarket_lookup4 fields changed
      • addedInput schema / $schema
        Added value: +"http://json-schema.org/draft-07/schema#"
      • removedInput schema / additionalProperties
        Removed value: -true
      • addedInput schema / properties
        Added value: +{
+  "k_number": {
+    "description": "510(k) or De Novo number, e.g. K252148 or DEN180001",
+    "pattern": "^(K|DEN)\\d{6}$",
+    "type": "string"
+  }
+}
      • addedInput schema / required
        Added value: +[
+  "k_number"
+]
    • Changeddevice_risk_lookup4 fields changed
      • addedInput schema / $schema
        Added value: +"http://json-schema.org/draft-07/schema#"
      • removedInput schema / additionalProperties
        Removed value: -true
      • addedInput schema / properties
        Added value: +{
+  "product_code": {
+    "description": "FDA product code, e.g. FRN",
+    "maxLength": 3,
+    "minLength": 3,
+    "type": "string"
+  }
+}
      • addedInput schema / required
        Added value: +[
+  "product_code"
+]
    • Changedevidence_cohort_stats3 fields changed
      • addedInput schema / $schema
        Added value: +"http://json-schema.org/draft-07/schema#"
      • removedInput schema / additionalProperties
        Removed value: -true
      • addedInput schema / properties
        Added value: +{
+  "panel": {
+    "description": "Advisory panel, e.g. Radiology; omit for all",
+    "type": "string"
+  }
+}
    • Changedevidence_search3 fields changed
      • addedInput schema / $schema
        Added value: +"http://json-schema.org/draft-07/schema#"
      • removedInput schema / additionalProperties
        Removed value: -true
      • addedInput schema / properties
        Added value: +{
+  "applicant": {
+    "description": "Substring match on applicant/company name",
+    "type": "string"
+  },
+  "has_clinical_data": {
+    "type": "boolean"
+  },
+  "has_pccp": {
+    "description": "Included a Predetermined Change Control Plan",
+    "type": "boolean"
+  },
+  "limit": {
+    "maximum": 200,
+    "minimum": 1,
+    "type": "integer"
+  },
+  "panel": {
+    "description": "Advisory panel, e.g. Radiology",
+    "type": "string"
+  },
+  "product_code": {
+    "description": "FDA product code, e.g. QAS",
+    "maxLength": 3,
+    "minLength": 3,
+    "type": "string"
+  },
+  "reports_any_sensitivity_metric": {
+    "description": "Reported any sensitivity metric (canonical — includes per-finding sensitivities, not just the top-level slot). Not a claim of cross-device comparability.",
+    "type": "boolean"
+  }
+}
    • Changedfirm_compliance_history4 fields changed
      • addedInput schema / $schema
        Added value: +"http://json-schema.org/draft-07/schema#"
      • removedInput schema / additionalProperties
        Removed value: -true
      • addedInput schema / properties
        Added value: +{
+  "fei_numbers": {
+    "description": "Optional exact FDA FEI numbers; improves Form 483 attribution.",
+    "items": {
+      "pattern": "^\\d{6,12}$",
+      "type": "string"
+    },
+    "maxItems": 20,
+    "type": "array"
+  },
+  "firm_name": {
+    "description": "FDA applicant or company name, e.g. 'Medtronic'",
+    "maxLength": 160,
+    "minLength": 2,
+    "type": "string"
+  },
+  "limit": {
+    "description": "Maximum records per source and events in the timeline (default 50).",
+    "maximum": 100,
+    "minimum": 1,
+    "type": "integer"
+  },
+  "product_codes": {
+    "description": "Optional FDA product-code scope. When omitted, Constat discovers codes from applicant matches in its device corpus.",
+    "items": {
+      "maxLength": 3,
+      "minLength": 3,
+      "type": "string"
+    },
+    "maxItems": 8,
+    "type": "array"
+  },
+  "since": {
+    "description": "Earliest event date, YYYY-MM-DD. Defaults to five years ago.",
+    "pattern": "^\\d{4}-\\d{2}-\\d{2}$",
+    "type": "string"
+  }
+}
      • addedInput schema / required
        Added value: +[
+  "firm_name"
+]
    • Changedpostmarket_search3 fields changed
      • addedInput schema / $schema
        Added value: +"http://json-schema.org/draft-07/schema#"
      • removedInput schema / additionalProperties
        Removed value: -true
      • addedInput schema / properties
        Added value: +{
+  "applicant": {
+    "description": "Substring match on applicant/company name",
+    "type": "string"
+  },
+  "has_drift_signal": {
+    "type": "boolean"
+  },
+  "limit": {
+    "maximum": 200,
+    "minimum": 1,
+    "type": "integer"
+  },
+  "maude_trend_up": {
+    "description": "Code-level MAUDE trend above its own 3-year baseline",
+    "type": "boolean"
+  },
+  "min_recalls_24mo": {
+    "description": "Product-code recalls in trailing 24 months",
+    "maximum": 9007199254740991,
+    "minimum": 0,
+    "type": "integer"
+  },
+  "panel": {
+    "description": "Advisory panel, e.g. Radiology",
+    "type": "string"
+  },
+  "product_code": {
+    "description": "FDA product code, e.g. QIH",
+    "maxLength": 3,
+    "minLength": 3,
+    "type": "string"
+  },
+  "signal_specificity": {
+    "description": "Restrict the drift-signal filter to one tier: 'device' = attributable to this device (own line re-cleared, own applicant's recall, predicate neighbors) — the high-signal tier; 'product_code' = observed in its category",
+    "enum": [
+      "device",
+      "product_code"
+    ],
+    "type": "string"
+  }
+}
    • Changedpredicate_chain4 fields changed
      • addedInput schema / $schema
        Added value: +"http://json-schema.org/draft-07/schema#"
      • removedInput schema / additionalProperties
        Removed value: -true
      • addedInput schema / properties
        Added value: +{
+  "depth": {
+    "description": "Max ancestry depth (default 4)",
+    "maximum": 6,
+    "minimum": 1,
+    "type": "integer"
+  },
+  "k_number": {
+    "description": "510(k) or De Novo number, e.g. K252148 or DEN180001",
+    "pattern": "^(K|DEN)\\d{6}$",
+    "type": "string"
+  }
+}
      • addedInput schema / required
        Added value: +[
+  "k_number"
+]
    • Changedreimbursement_lookup3 fields changed
      • addedInput schema / $schema
        Added value: +"http://json-schema.org/draft-07/schema#"
      • removedInput schema / additionalProperties
        Removed value: -true
      • addedInput schema / properties
        Added value: +{
+  "cpt_code": {
+    "description": "Bare CPT code, e.g. 75580 or 0932T",
+    "pattern": "^\\d{4,5}[A-Z]?$",
+    "type": "string"
+  },
+  "k_number": {
+    "description": "FDA clearance number, e.g. DEN170073 or K252148",
+    "pattern": "^(K|DEN)\\d{6}$",
+    "type": "string"
+  }
+}
    • Changedreimbursement_search3 fields changed
      • addedInput schema / $schema
        Added value: +"http://json-schema.org/draft-07/schema#"
      • removedInput schema / additionalProperties
        Removed value: -true
      • addedInput schema / properties
        Added value: +{
+  "applicant": {
+    "description": "Substring match on device maker / applicant name",
+    "type": "string"
+  },
+  "cpt_category": {
+    "description": "CPT category",
+    "enum": [
+      "I",
+      "III",
+      "unknown"
+    ],
+    "type": "string"
+  },
+  "has_cms_rate": {
+    "description": "Only pathways with a known CMS dollar rate",
+    "type": "boolean"
+  },
+  "limit": {
+    "maximum": 200,
+    "minimum": 1,
+    "type": "integer"
+  },
+  "mechanism": {
+    "description": "Payment mechanism",
+    "enum": [
+      "ntap",
+      "cat_iii_apc",
+      "cat_i",
+      "hcpcs",
+      "lcd",
+      "none"
+    ],
+    "type": "string"
+  },
+  "ntap_status": {
+    "enum": [
+      "active",
+      "expired",
+      "granted",
+      "none"
+    ],
+    "type": "string"
+  }
+}
    • Changedreimbursement_stats3 fields changed
      • addedInput schema / $schema
        Added value: +"http://json-schema.org/draft-07/schema#"
      • removedInput schema / additionalProperties
        Removed value: -true
      • addedInput schema / properties
        Added value: +{}
    • Changedvehicle_risk_lookup4 fields changed
      • addedInput schema / $schema
        Added value: +"http://json-schema.org/draft-07/schema#"
      • removedInput schema / additionalProperties
        Removed value: -true
      • addedInput schema / properties
        Added value: +{
+  "make": {
+    "description": "e.g. honda",
+    "minLength": 2,
+    "type": "string"
+  },
+  "model": {
+    "description": "e.g. civic",
+    "minLength": 1,
+    "type": "string"
+  },
+  "year": {
+    "description": "model year, e.g. 2020",
+    "pattern": "^\\d{4}$",
+    "type": "string"
+  }
+}
      • addedInput schema / required
        Added value: +[
+  "make",
+  "model",
+  "year"
+]
    • Changedwatchlist_diff3 fields changed
      • addedInput schema / $schema
        Added value: +"http://json-schema.org/draft-07/schema#"
      • removedInput schema / additionalProperties
        Removed value: -true
      • addedInput schema / properties
        Added value: +{
+  "limit": {
+    "description": "Maximum changes to return (default 100).",
+    "maximum": 200,
+    "minimum": 1,
+    "type": "integer"
+  },
+  "product_codes": {
+    "description": "FDA product codes to poll. Omit for the default Radar watchlist.",
+    "items": {
+      "maxLength": 3,
+      "minLength": 3,
+      "type": "string"
+    },
+    "maxItems": 20,
+    "type": "array"
+  },
+  "since": {
+    "description": "Return changes on or after this ISO date or UTC timestamp. Defaults to the last seven days; pass the prior response's next_since for exact polling.",
+    "pattern": "^\\d{4}-\\d{2}-\\d{2}(?:T\\d{2}:\\d{2}:\\d{2}(?:\\.\\d{1,3})?Z)?$",
+    "type": "string"
+  }
+}
  3. 14 tool updates
    • Changedcohort_postmarket_stats3 fields changed
      • removedInput schema / $schema
        Removed value: -"http://json-schema.org/draft-07/schema#"
      • addedInput schema / additionalProperties
        Added value: +true
      • removedInput schema / properties
        Removed value: -{
-  "panel": {
-    "description": "Advisory panel, e.g. Radiology; omit for all",
-    "type": "string"
-  }
-}
    • Changeddevice_evidence_lookup4 fields changed
      • removedInput schema / $schema
        Removed value: -"http://json-schema.org/draft-07/schema#"
      • addedInput schema / additionalProperties
        Added value: +true
      • removedInput schema / properties
        Removed value: -{
-  "k_number": {
-    "description": "510(k) or De Novo number, e.g. K252148 or DEN180001",
-    "pattern": "^(K|DEN)\\d{6}$",
-    "type": "string"
-  }
-}
      • removedInput schema / required
        Removed value: -[
-  "k_number"
-]
    • Changeddevice_postmarket_lookup4 fields changed
      • removedInput schema / $schema
        Removed value: -"http://json-schema.org/draft-07/schema#"
      • addedInput schema / additionalProperties
        Added value: +true
      • removedInput schema / properties
        Removed value: -{
-  "k_number": {
-    "description": "510(k) or De Novo number, e.g. K252148 or DEN180001",
-    "pattern": "^(K|DEN)\\d{6}$",
-    "type": "string"
-  }
-}
      • removedInput schema / required
        Removed value: -[
-  "k_number"
-]
    • Changeddevice_risk_lookup4 fields changed
      • removedInput schema / $schema
        Removed value: -"http://json-schema.org/draft-07/schema#"
      • addedInput schema / additionalProperties
        Added value: +true
      • removedInput schema / properties
        Removed value: -{
-  "product_code": {
-    "description": "FDA product code, e.g. FRN",
-    "maxLength": 3,
-    "minLength": 3,
-    "type": "string"
-  }
-}
      • removedInput schema / required
        Removed value: -[
-  "product_code"
-]
    • Changedevidence_cohort_stats3 fields changed
      • removedInput schema / $schema
        Removed value: -"http://json-schema.org/draft-07/schema#"
      • addedInput schema / additionalProperties
        Added value: +true
      • removedInput schema / properties
        Removed value: -{
-  "panel": {
-    "description": "Advisory panel, e.g. Radiology; omit for all",
-    "type": "string"
-  }
-}
    • Changedevidence_search3 fields changed
      • removedInput schema / $schema
        Removed value: -"http://json-schema.org/draft-07/schema#"
      • addedInput schema / additionalProperties
        Added value: +true
      • removedInput schema / properties
        Removed value: -{
-  "applicant": {
-    "description": "Substring match on applicant/company name",
-    "type": "string"
-  },
-  "has_clinical_data": {
-    "type": "boolean"
-  },
-  "has_pccp": {
-    "description": "Included a Predetermined Change Control Plan",
-    "type": "boolean"
-  },
-  "limit": {
-    "maximum": 200,
-    "minimum": 1,
-    "type": "integer"
-  },
-  "panel": {
-    "description": "Advisory panel, e.g. Radiology",
-    "type": "string"
-  },
-  "product_code": {
-    "description": "FDA product code, e.g. QAS",
-    "maxLength": 3,
-    "minLength": 3,
-    "type": "string"
-  },
-  "reports_any_sensitivity_metric": {
-    "description": "Reported any sensitivity metric (canonical — includes per-finding sensitivities, not just the top-level slot). Not a claim of cross-device comparability.",
-    "type": "boolean"
-  }
-}
    • Changedfirm_compliance_history4 fields changed
      • removedInput schema / $schema
        Removed value: -"http://json-schema.org/draft-07/schema#"
      • addedInput schema / additionalProperties
        Added value: +true
      • removedInput schema / properties
        Removed value: -{
-  "fei_numbers": {
-    "description": "Optional exact FDA FEI numbers; improves Form 483 attribution.",
-    "items": {
-      "pattern": "^\\d{6,12}$",
-      "type": "string"
-    },
-    "maxItems": 20,
-    "type": "array"
-  },
-  "firm_name": {
-    "description": "FDA applicant or company name, e.g. 'Medtronic'",
-    "maxLength": 160,
-    "minLength": 2,
-    "type": "string"
-  },
-  "limit": {
-    "description": "Maximum records per source and events in the timeline (default 50).",
-    "maximum": 100,
-    "minimum": 1,
-    "type": "integer"
-  },
-  "product_codes": {
-    "description": "Optional FDA product-code scope. When omitted, Constat discovers codes from applicant matches in its device corpus.",
-    "items": {
-      "maxLength": 3,
-      "minLength": 3,
-      "type": "string"
-    },
-    "maxItems": 8,
-    "type": "array"
-  },
-  "since": {
-    "description": "Earliest event date, YYYY-MM-DD. Defaults to five years ago.",
-    "pattern": "^\\d{4}-\\d{2}-\\d{2}$",
-    "type": "string"
-  }
-}
      • removedInput schema / required
        Removed value: -[
-  "firm_name"
-]
    • Changedpostmarket_search3 fields changed
      • removedInput schema / $schema
        Removed value: -"http://json-schema.org/draft-07/schema#"
      • addedInput schema / additionalProperties
        Added value: +true
      • removedInput schema / properties
        Removed value: -{
-  "applicant": {
-    "description": "Substring match on applicant/company name",
-    "type": "string"
-  },
-  "has_drift_signal": {
-    "type": "boolean"
-  },
-  "limit": {
-    "maximum": 200,
-    "minimum": 1,
-    "type": "integer"
-  },
-  "maude_trend_up": {
-    "description": "Code-level MAUDE trend above its own 3-year baseline",
-    "type": "boolean"
-  },
-  "min_recalls_24mo": {
-    "description": "Product-code recalls in trailing 24 months",
-    "maximum": 9007199254740991,
-    "minimum": 0,
-    "type": "integer"
-  },
-  "panel": {
-    "description": "Advisory panel, e.g. Radiology",
-    "type": "string"
-  },
-  "product_code": {
-    "description": "FDA product code, e.g. QIH",
-    "maxLength": 3,
-    "minLength": 3,
-    "type": "string"
-  },
-  "signal_specificity": {
-    "description": "Restrict the drift-signal filter to one tier: 'device' = attributable to this device (own line re-cleared, own applicant's recall, predicate neighbors) — the high-signal tier; 'product_code' = observed in its category",
-    "enum": [
-      "device",
-      "product_code"
-    ],
-    "type": "string"
-  }
-}
    • Changedpredicate_chain4 fields changed
      • removedInput schema / $schema
        Removed value: -"http://json-schema.org/draft-07/schema#"
      • addedInput schema / additionalProperties
        Added value: +true
      • removedInput schema / properties
        Removed value: -{
-  "depth": {
-    "description": "Max ancestry depth (default 4)",
-    "maximum": 6,
-    "minimum": 1,
-    "type": "integer"
-  },
-  "k_number": {
-    "description": "510(k) or De Novo number, e.g. K252148 or DEN180001",
-    "pattern": "^(K|DEN)\\d{6}$",
-    "type": "string"
-  }
-}
      • removedInput schema / required
        Removed value: -[
-  "k_number"
-]
    • Changedreimbursement_lookup3 fields changed
      • removedInput schema / $schema
        Removed value: -"http://json-schema.org/draft-07/schema#"
      • addedInput schema / additionalProperties
        Added value: +true
      • removedInput schema / properties
        Removed value: -{
-  "cpt_code": {
-    "description": "Bare CPT code, e.g. 75580 or 0932T",
-    "pattern": "^\\d{4,5}[A-Z]?$",
-    "type": "string"
-  },
-  "k_number": {
-    "description": "FDA clearance number, e.g. DEN170073 or K252148",
-    "pattern": "^(K|DEN)\\d{6}$",
-    "type": "string"
-  }
-}
    • Changedreimbursement_search3 fields changed
      • removedInput schema / $schema
        Removed value: -"http://json-schema.org/draft-07/schema#"
      • addedInput schema / additionalProperties
        Added value: +true
      • removedInput schema / properties
        Removed value: -{
-  "applicant": {
-    "description": "Substring match on device maker / applicant name",
-    "type": "string"
-  },
-  "cpt_category": {
-    "description": "CPT category",
-    "enum": [
-      "I",
-      "III",
-      "unknown"
-    ],
-    "type": "string"
-  },
-  "has_cms_rate": {
-    "description": "Only pathways with a known CMS dollar rate",
-    "type": "boolean"
-  },
-  "limit": {
-    "maximum": 200,
-    "minimum": 1,
-    "type": "integer"
-  },
-  "mechanism": {
-    "description": "Payment mechanism",
-    "enum": [
-      "ntap",
-      "cat_iii_apc",
-      "cat_i",
-      "hcpcs",
-      "lcd",
-      "none"
-    ],
-    "type": "string"
-  },
-  "ntap_status": {
-    "enum": [
-      "active",
-      "expired",
-      "granted",
-      "none"
-    ],
-    "type": "string"
-  }
-}
    • Changedreimbursement_stats3 fields changed
      • removedInput schema / $schema
        Removed value: -"http://json-schema.org/draft-07/schema#"
      • addedInput schema / additionalProperties
        Added value: +true
      • removedInput schema / properties
        Removed value: -{}
    • Changedvehicle_risk_lookup4 fields changed
      • removedInput schema / $schema
        Removed value: -"http://json-schema.org/draft-07/schema#"
      • addedInput schema / additionalProperties
        Added value: +true
      • removedInput schema / properties
        Removed value: -{
-  "make": {
-    "description": "e.g. honda",
-    "minLength": 2,
-    "type": "string"
-  },
-  "model": {
-    "description": "e.g. civic",
-    "minLength": 1,
-    "type": "string"
-  },
-  "year": {
-    "description": "model year, e.g. 2020",
-    "pattern": "^\\d{4}$",
-    "type": "string"
-  }
-}
      • removedInput schema / required
        Removed value: -[
-  "make",
-  "model",
-  "year"
-]
    • Changedwatchlist_diff3 fields changed
      • removedInput schema / $schema
        Removed value: -"http://json-schema.org/draft-07/schema#"
      • addedInput schema / additionalProperties
        Added value: +true
      • removedInput schema / properties
        Removed value: -{
-  "limit": {
-    "description": "Maximum changes to return (default 100).",
-    "maximum": 200,
-    "minimum": 1,
-    "type": "integer"
-  },
-  "product_codes": {
-    "description": "FDA product codes to poll. Omit for the default Radar watchlist.",
-    "items": {
-      "maxLength": 3,
-      "minLength": 3,
-      "type": "string"
-    },
-    "maxItems": 20,
-    "type": "array"
-  },
-  "since": {
-    "description": "Return changes on or after this ISO date or UTC timestamp. Defaults to the last seven days; pass the prior response's next_since for exact polling.",
-    "pattern": "^\\d{4}-\\d{2}-\\d{2}(?:T\\d{2}:\\d{2}:\\d{2}(?:\\.\\d{1,3})?Z)?$",
-    "type": "string"
-  }
-}
  4. 2 tool updates
    • Addedfirm_compliance_history
    • Addedwatchlist_diff
  5. 3 tool updates
    • Changeddevice_evidence_lookup2 fields changed
      • changedInput schema / properties / k_number / description
        Previous value: -"510(k) number, e.g. K252148"New value: +"510(k) or De Novo number, e.g. K252148 or DEN180001"
      • changedInput schema / properties / k_number / pattern
        Previous value: -"^K\\d{6}$"New value: +"^(K|DEN)\\d{6}$"
    • Changeddevice_postmarket_lookup2 fields changed
      • changedInput schema / properties / k_number / description
        Previous value: -"510(k) number, e.g. K252148"New value: +"510(k) or De Novo number, e.g. K252148 or DEN180001"
      • changedInput schema / properties / k_number / pattern
        Previous value: -"^K\\d{6}$"New value: +"^(K|DEN)\\d{6}$"
    • Changedpredicate_chain2 fields changed
      • changedInput schema / properties / k_number / description
        Previous value: -"510(k) number, e.g. K252148"New value: +"510(k) or De Novo number, e.g. K252148 or DEN180001"
      • changedInput schema / properties / k_number / pattern
        Previous value: -"^K\\d{6}$"New value: +"^(K|DEN)\\d{6}$"
  6. 1 tool update
    • Changedpostmarket_search1 field changed
      • addedInput schema / properties / signal_specificity
        Added value: +{
+  "description": "Restrict the drift-signal filter to one tier: 'device' = attributable to this device (own line re-cleared, own applicant's recall, predicate neighbors) — the high-signal tier; 'product_code' = observed in its category",
+  "enum": [
+    "device",
+    "product_code"
+  ],
+  "type": "string"
+}
  7. 7 tool updates
    • Addedcohort_postmarket_stats
    • Addeddevice_postmarket_lookup
    • Changedevidence_search3 fields changed
      • changedInput schema / properties / product_code / description
        Previous value: -"FDA product code, e.g. QIH"New value: +"FDA product code, e.g. QAS"
      • addedInput schema / properties / reports_any_sensitivity_metric
        Added value: +{
+  "description": "Reported any sensitivity metric (canonical — includes per-finding sensitivities, not just the top-level slot). Not a claim of cross-device comparability.",
+  "type": "boolean"
+}
      • removedInput schema / properties / reports_sens_spec
        Removed value: -{
-  "description": "Reported both sensitivity and specificity",
-  "type": "boolean"
-}
    • Addedpostmarket_search
    • Addedreimbursement_lookup
    • Addedreimbursement_search
    • Addedreimbursement_stats
  8. 6 tool updates
    • First observeddevice_evidence_lookup
    • First observeddevice_risk_lookup
    • First observedevidence_cohort_stats
    • First observedevidence_search
    • First observedpredicate_chain
    • First observedvehicle_risk_lookup

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TDQS

A4/5.0
Disambiguation4/5

Most tools have clearly distinct purposes, e.g., device_evidence_lookup vs device_postmarket_lookup, but cohort_postmarket_stats and evidence_cohort_stats could cause minor confusion despite detailed descriptions. Overall, boundaries are well-defined.

Naming Consistency5/5

All tool names follow a consistent snake_case verb_noun pattern (e.g., device_evidence_lookup, reimbursement_search). The naming is predictable and easy to parse.

Tool Count5/5

With 14 tools covering premarket evidence, postmarket signals, risk, compliance, reimbursement, and more, the count is well-scoped for the FDA device evidence lifecycle. No tools feel redundant or missing.

Completeness5/5

The tool set comprehensively covers the FDA device evidence lifecycle: premarket lookup and search, postmarket stats and search, risk assessment, compliance history, reimbursement pathways, and predicate chain. The inclusion of a vehicle risk tool is a slight outlier but does not create a gap in the core domain.

Resources