A general framework for governing marketed AI/ML medical devices
Bibliographic record
Abstract
This project represents the first systematic assessment of the US Food and Drug Administration's postmarket surveillance of legally marketed artificial intelligence and machine learning based medical devices. We focus on the Manufacturer and User Facility Device Experience database-the FDA's central tool for tracking the safety of marketed AI/ML devices. In particular, we evaluate the data pertaining to adverse events associated with approximately 950 medical devices incorporating AI/ML functions for devices approved between 2010 through 2023, and we find that the existing system is insufficient for properly assessing the safety and effectiveness of AI/ML devices. In particular, we make three contributions: (1) characterize the adverse event reports for such devices, (2) examine the ways in which the existing FDA adverse reporting system for medical devices falls short, and (3) suggest changes FDA might consider in its approach to adverse event reporting for devices incorporating AI/ML functions.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.073 | 0.060 |
| Meta-epidemiology (narrow) | 0.002 | 0.002 |
| Meta-epidemiology (broad) | 0.002 | 0.006 |
| Bibliometrics | 0.008 | 0.005 |
| Science and technology studies | 0.007 | 0.021 |
| Scholarly communication | 0.021 | 0.031 |
| Open science | 0.010 | 0.008 |
| Research integrity | 0.018 | 0.012 |
| Insufficient payload (model declined to judge) | 0.016 | 0.007 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".