FDA-Authorized Orthopaedic AI Devices: Frozen Dataset and Reproducibility Materials

Dataset title: FDA-Authorized Orthopaedic AI Devices: Frozen Dataset and Reproducibility Materials Associated research: Device function versus AI function in FDA-authorized orthopaedic planning and navigation devices: a cross-sectional analysis of regulatory decision documents. Description This repository supports an original cross-sectional study examining the distinction between device-level intended functions and the functions specifically attributed to artificial intelligence in FDA-authorized musculoskeletal medical devices. The study screened 1,614 FDA AI-enabled device authorizations and identified 138 eligible musculoskeletal authorizations. Among 60 surgical planning or intraoperative authorizations, the AI-component function was described in 49. Five of these 49 authorizations (10.2%) described AI-generated planning elements, proposals, or predictions. The research distinguishes AI-generated anatomical information from AI-generated planning decisions and examines the availability of numerical performance reporting in publicly accessible FDA regulatory documents. The deposited reproducibility package corresponds to the frozen analysis dataset (coding version v6, objective variables r2). Purpose To support research transparency, reproducibility, and examination of the classification framework and reported findings. Limitations The classifications reflect information disclosed in publicly available FDA regulatory documents. Absence of a documented AI function or performance metric should not be interpreted as evidence that the function or testing was absent.