Observed arrival · 2026-08-31
Device Evidence: An FDA AI Device Transparency Scorecard
A searchable audit of FDA-authorised AI medical-device summaries, their evidence claims, and the clearance documents linked through each device’s lineage.
Field notes
The project treats a 510(k) clearance as a chain rather than an isolated document, following each device back through its predicates and recording where the public trail stops. Its scoring framework checks thirteen elements, from study design and sample size to AUC and patient outcomes; the homepage reports patient outcomes in only 1.2% of 1,462 summaries. Unreadable documents are kept separate from confirmed absences, while product-code pages expose differences in disclosure rates.
Observed signals
Read the marks
Editorial observations of this landing page, not a rating.
One card from the complete issue