device_evidence_lookup
Look up FDA-accepted premarket evidence for AI/ML-enabled devices by 510(k) number. Returns parsed summary fields with verbatim source quotes.
Instructions
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.
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| k_number | Yes | 510(k) or De Novo number, e.g. K252148 or DEN180001 |