evidence_search
Search FDA 510(k) evidence for AI/ML devices by product code, panel, applicant, clinical data, sensitivity metrics, or PCCP. Returns matched records with parsed evidence.
Instructions
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.
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| limit | No | ||
| panel | No | Advisory panel, e.g. Radiology | |
| has_pccp | No | Included a Predetermined Change Control Plan | |
| applicant | No | Substring match on applicant/company name | |
| product_code | No | FDA product code, e.g. QAS | |
| has_clinical_data | No | ||
| reports_any_sensitivity_metric | No | Reported any sensitivity metric (canonical — includes per-finding sensitivities, not just the top-level slot). Not a claim of cross-device comparability. |