ReviewJournal of medical systems2023
The 510(k) Third Party Review Program: Promise and Potential.
Review in Journal of medical systems, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed.
- Clinical Evidence and FDA Recalls of Artificial Intelligence-Enabled Medical Devices.JAMA network open · 2026Article
- Commercial Translation of Electrochemical Biosensors: Supply Chain Strategy, Scale-Up Manufacturing, and Regulatory-Quality Considerations.Biosensors · 2026Review
- Scaling medical device regulatory science using large language models.NPJ digital medicine · 2026Article
- Predetermined Change Control Plans: Guiding Principles for Advancing Safe, Effective, and High-Quality AI-ML Technologies.JMIR AI · 2025Article
- From bench to bedside and back: translational cardiovascular interventions in veterinary medicine.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2025Review
- Energy-Based Medical Devices in Plastic Surgery: A Comparison of FDA-Approved Indications to Advertised Claims.Aesthetic surgery journal. Open forum · 2024Article
- Analysis of Trends in FDA-Recalled Hip Arthroplasty Devices: A Retrospective Review.JB & JS open accessArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Every year, the Food and Drug Administration (FDA) clears approximately 3,000 medical devices for marketing via the 510(k) pathway. These constitute 99% of all devices approved for human use and includes the premarket review of many devices incorporating newer technology such as artificial intelligence (AI), machine learning (ML), and other software. As the complexity of these novel technologies and the number of applications is expected to increase in the coming years, statutory changes such as the 2016 21
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.