Reproducibility package: Are AI-enabled medical devices recalled more often than comparable devices? A same-category cohort study of FDA 510(k) clearances, 2004-2024
Year: 2026
Type: dataset
Abstract: Reproducibility package for a retrospective cohort study comparing recalls, adverse event reports, and reports of injury or death between devices on the US FDA AI-enabled medical device list and other Class II 510(k) devices cleared in the same product category and year (2004-2024; recall follow-up to September 30, 2026). Contents: analysis code (cohort reconstruction from hashed openFDA exports, Cox models with applicant-clustered variance, cause-specific and device-type analyses, manufacturer analyses, outcome-defined calendar-year placebo analysis and simulation, MAUDE linkage), the derived analytic cohort (58,979 submissions), all model outputs reported in the manuscript and appendix, the blinded two-reviewer source-document audit with consensus decisions, and source manifests with URLs, export dates and SHA-256 hashes. Raw FDA files are public and are not redistributed. See README.md for instructions.
Authors: Chang, Liang-Cheng, Chiu, Hsiu-Hsing
Institution: Shih Chien University
Language: English
Topic: Healthcare Regulation
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7224879255