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 and shared-event-clustered variance, cause-specific and device-type analyses, manufacturer analyses, outcome-defined calendar-year placebo analysis and simulation, MAUDE linkage, manuscript build), the derived analytic cohort (58,979 submissions), all model outputs reported in the manuscript and appendix, the source-document audit (56 records), 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. Correction in version 2.9. Version 2.3 described the second source-document review as a blinded human review. Both full reviews were AI-assisted: the first with Anthropic Claude Opus 5.5 during analysis (October 28, 2026) and the second with OpenAI ChatGPT 6.1 (October 30, 2026), blinded to the first review. The authors adjudicated the six disagreements. A co-author independently re-coded 20 of the 56 records without AI tools (20/20 agreement with the final categories); the completed form and comparison code are included. Version 2.9 also counts applicant size using only clearances before the index date, adds shared-event clustering, adds missing data-preparation scripts and figure sources, and records all changes in README.md.