The false positive paradox: Examining real-world clinical predictive performance of FDA-authorized AI devices for radiology using clinical prevalence

Abstract

Abstract 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 metrics like sensitivity and specificity do not necessarily translate into high positive predictive value (PPV) due to the influence of target disease prevalence. We show the importance of disclosing the false discovery (FDR) and false omission rates (FOR) and argue that this transparency enables clinicians to select AI systems that balance false positive and false negative costs in a clinically, ethically, and financially appropriate manner. Finally, we provide recommendations for what data should be provided to best serve practices and radiologists.

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