Article

Beyond the Black Box: Avenues for Transparency in Regulating Radiological AI/ML-enabled SaMD via the FDA 510(k) Pathway

2024-07-12

Abstract excerpt

<h4>Background</h4> The majority of AI/ML-enabled software as a medical device (SaMD) has been cleared through the FDA 510(k) pathway, but with limited transparency on algorithm development details. Because algorithm quality depends on the quality of the training data and algorithmic input, this study aimed to assess the availability of algorithm development details in the 510(k) summaries of AI/ML-enabled SaMD....

Topics

Open a Topic to create a Post that cites this publication.

Identifiers and source

Literature Corpus work: 95fe1818-063e-54f8-be1a-dfda4e2809d2
DOI: 10.1101/2024.07.12.24309602

Open publication

Related research

Semantic proximity does not establish scientific evidence.

Click a neighbor to travelStep 1 · 12 closest

Beyond the Black Box: Avenues for Transparency in Regulating Radiological AI/ML-enabled SaMD via the FDA 510(k) PathwayDOI 10.1101/2024.07.12.24309602Read

The clinician-AI interface: intended use and explainability in FDA-cleared AI devices for medical image interpretationSemantic proximity Read

Public evidence on AI products for digital pathologySemantic proximity Read

The Challenge Dataset – simple evaluation for safe, transparent healthcare AI deploymentSemantic proximity Read

How AI is used in FDA-authorized medical devices: a taxonomy across 1,016 authorizationsSemantic proximity Read

Dynamic AI Risk Loop (DARL): A Continuous Risk Management Framework for AI-Enabled Health Information Systems in Medical Device SoftwareSemantic proximity Read

A Guide for the Deployment, Validation, and Accreditation of Clinical Digital Pathology ToolsSemantic proximity Read

Systematic post-publication accuracy assessment in medical educational content: development and pilot validation of a five-category taxonomic frameworkSemantic proximity Read

Artificial Intelligence and Failure Mode and Effect Analysis Framework to Reduce Diagnostic Errors in PathologySemantic proximity Read

Artificial Intelligence in Radiology: Why Retrospective Performance Does Not Ensure Clinical UtilitySemantic proximity Read

Exact Probability Distribution for the ROC Area Under CurveSemantic proximity Read

Why Radiomics Rarely Reaches the Clinic: Reproducibility, Validation and Evidence Gap – A Critical Narrative ReviewSemantic proximity Read

Evaluation of Gender Bias in the Evaluation of Synthetic Cardiovascular Disease Cases with Open Source LLMsSemantic proximity Read