Reproducibility package: Recalls and adverse event reports of AI-enabled medical devices compared with same-category devices (510(k) cohort study)

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.