Constat — 483 Risk Radar
Server Configuration
Describes the environment variables required to run the server.
| Name | Required | Description | Default |
|---|---|---|---|
No arguments | |||
Instructions
Guidance the server publishes about itself, which clients place ahead of the tool catalog so the model reads it before choosing anything.
This server publishes no instructions, or was last inspected before Glama recorded them.
Capabilities
Features and capabilities supported by this server
Protocol revision2025-11-25
| Capability | Details |
|---|---|
| tools | {} |
Tools
Functions exposed to the LLM to take actions
| Name | Description |
|---|---|
| device_risk_lookupA | Review a medical-device category's public FDA signals by three-letter product code (e.g. FRN = infusion pump). Returns recalls, MAUDE adverse-event trend, warning-letter matches, a normalized category signal, its driver contributions, and interpretation limits. It does not predict enforcement against a firm. |
| firm_compliance_historyA | Build a recent, source-bounded FDA public-record timeline for a device firm: matched recalls, warning letters, and Form 483 citations where exact FEI numbers are available. Product codes are discovered from Constat's AI/ML-device corpus or may be supplied explicitly. Returns attribution and coverage limits with the records; it is not a finding of noncompliance or a prediction of FDA action. |
| watchlist_diffA | Return machine-generated FDA public-record changes detected for monitored product codes since a caller-supplied date, plus each code's latest category snapshot and postmarket coverage. Defaults to Constat Radar's five-code watchlist and the last seven days. Analyst verdict text and internal review status are excluded; use next_since as the next polling cursor. |
| device_evidence_lookupA | Look up the structured premarket evidence FDA accepted for a specific AI/ML-enabled device by 510(k) number (e.g. K252148). Returns parsed summary fields — validation study design, sample sizes, endpoints, reported performance, predicate chain, PCCP — each with a verbatim source quote and page. Null means the summary did not state it. |
| evidence_searchA | Find AI/ML device clearances by filter — product code, panel, applicant, and whether the submission reported clinical data, any sensitivity metric, or a PCCP. Answers 'what evidence did FDA accept for devices like mine'. Returns matching records with their parsed evidence. Presence flags are descriptive: 'reports a sensitivity metric' is not 'reports a comparable sensitivity' — analysis units differ across devices. |
| predicate_chainA | Trace the predicate ancestry of a 510(k) device, with each cited predicate's age (how many years old the predicate was when the child cleared). Reveals how AI/ML devices chain to older predicates. |
| evidence_cohort_statsA | Reporting-rate stats across the parsed AI/ML corpus (optionally by panel). Each rate is a presence figure with its denominator — 'reported in X of Y audited devices' — never a pooled performance value. Excludes not-yet-parsed devices from every denominator and discloses the parse queue separately. Predicate age (median years between a clearance and its cited predicates) is included when decision-date coverage clears a 60% floor, and withheld otherwise. |
| device_postmarket_lookupA | Post-clearance intelligence for one AI/ML device by 510(k) number: its product code's recalls, MAUDE adverse-event level and trend, warning-letter and 483 matches for the applicant, plus per-device drift signals (adverse-event inflection, re-clearances of the same device line, software-recall patterns, predicate-cohort recall activity). Descriptive observables with sources — never a safety judgment. |
| postmarket_searchA | Find AI/ML devices by postmarket criteria — product code, panel, applicant, whether any drift signal exists, minimum recalls in 24 months, or a rising MAUDE trend. Returns per-device postmarket summaries with drift-signal counts. |
| cohort_postmarket_statsB | Postmarket presence rates across the snapshotted AI/ML device cohort (optionally by panel): share with any recall in 24 months, with a rising MAUDE trend, with any drift signal, with a warning-letter match — every rate with its denominator inline, never pooled across devices. |
| reimbursement_lookupA | Trace the clearance-to-payment pathway for an AI/ML device by FDA clearance number (K/DEN, e.g. DEN170073) OR bare CPT code (e.g. 75580). Returns every payment mechanism (NTAP add-on, Category I/III CPT + CMS rate, HCPCS, MAC LCD) with amounts, effective dates, and source links, plus any commercial/MAC payer coverage policies that reference the clearance or its codes. Answers 'who got paid, how much, through which mechanism, on what basis.' CPT codes are bare factual identifiers only — no procedure descriptors; follow the CMS source link for the official descriptor. |
| reimbursement_searchA | Find AI/ML device payment pathways by mechanism — e.g. 'devices that got NTAP', 'devices paid under a Category I CPT code', 'pathways with a known CMS dollar rate'. Filters: mechanism, CPT category, NTAP status, applicant. Returns pathways with amounts, effective dates, and sources. Use reimbursement_stats for the mechanism distribution (never a single pooled reimbursement rate). |
| reimbursement_statsA | Distribution of payment mechanisms across the AI/ML reimbursement corpus — pathway and distinct-device counts per mechanism (NTAP, Cat I, Cat III/APC, …) with the min/median/max dollar amounts for each. Deliberately never a single pooled 'reimbursement rate': NTAP add-on amounts and CMS rates are different measurements and are reported separately with their own spreads. |
| vehicle_risk_lookupA | Look up NHTSA safety history for a vehicle by make, model, and model year. Returns recall campaigns and complaint statistics (crashes, fires, injuries, top components). |
Prompts
Interactive templates invoked by user choice
| Name | Description |
|---|---|
No prompts | |
Resources
Contextual data attached and managed by the client
| Name | Description |
|---|---|
No resources | |
TDQS
Scored across 14 tools
Each tool has a clearly distinct purpose: device-level premarket/postmarket lookups, firm compliance history, search across evidence/postmarket/reimbursement, statistical aggregates, predicate tracing, watchlist diff, and even a vehicle safety lookup. The detailed descriptions further minimize ambiguity.
Tool names follow a consistent pattern: domain prefix (device_, firm_, evidence_, etc.) plus operation suffix (lookup, search, stats, diff, chain). All snake_case. The sole outlier vehicle_risk_lookup still follows the same pattern, maintaining overall consistency.
14 tools is on the higher end of the ideal range (3-15) but each tool serves a specific, non-redundant purpose within the regulatory intelligence domain. The count is reasonable given the breadth of covered areas (premarket, postmarket, reimbursement, and vehicle safety).
The tool set covers the key aspects of medical device regulatory intelligence: premarket evidence, postmarket surveillance, reimbursement, firm compliance, and trend monitoring. However, the inclusion of vehicle_risk_lookup (NHTSA) is a slight domain mismatch, and there is no tool for listing or searching product codes/panels directly, though these are used as filters elsewhere.