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Early Recalls and Clinical Validation Gaps in Artificial Intelligence-Enabled Medical Devices.

作者信息

Lee Branden, Kramer Patrick, Sandri Sara, Chanda Ritika, Favorito Crystal, Nasef Olivia, Ross Joseph S, Sharfstein Joshua, Dai Tinglong

机构信息

Department of Orthopaedic Surgery, Johns Hopkins Medicine, Baltimore, Maryland.

School of Medicine, Johns Hopkins University, Baltimore, Maryland.

出版信息

JAMA Health Forum. 2025 Aug 1;6(8):e253172. doi: 10.1001/jamahealthforum.2025.3172.

DOI:10.1001/jamahealthforum.2025.3172
PMID:40844774
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12374217/
Abstract
摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f91/12374217/7192f3586eb8/jamahealthforum-e253172-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f91/12374217/515a3c8e08c9/jamahealthforum-e253172-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f91/12374217/7192f3586eb8/jamahealthforum-e253172-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f91/12374217/515a3c8e08c9/jamahealthforum-e253172-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6f91/12374217/7192f3586eb8/jamahealthforum-e253172-g002.jpg

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本文引用的文献

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NPJ Digit Med. 2024 Dec 3;7(1):351. doi: 10.1038/s41746-024-01357-5.
2
FDA-cleared artificial intelligence and machine learning-based medical devices and their 510(k) predicate networks.FDA 批准的人工智能和基于机器学习的医疗器械及其 510(k) 前序网络。
Lancet Digit Health. 2023 Sep;5(9):e618-e626. doi: 10.1016/S2589-7500(23)00126-7.
3
Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022.
2018年至2022年I类医疗器械召回中唯一设备标识符的可用性
JAMA Intern Med. 2023 Jul 1;183(7):735-737. doi: 10.1001/jamainternmed.2023.0727.
4
Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017.2008-2017 年美国食品和药物管理局 510(k) 审批和上市前批准的医疗器械召回风险。
JAMA Netw Open. 2021 May 3;4(5):e217274. doi: 10.1001/jamanetworkopen.2021.7274.