在整形外科手术中获得FDA批准的人工智能医疗设备
Branden Lee1, Mitchell Jay, Henry Fox
1From the Department of Orthopaedic Surgery, Johns Hopkins Medicine (Mr. Lee, Dr. Fox, Dr. Padley, and Dr. Levin); School of Medicine, Johns Hopkins University (Mr. Lee and Mr. Jay); Carey Business School, Johns Hopkins University, Baltimore, MD (Dr. Dai); Hopkins Business of Health Initiative, Johns Hopkins University, Washington, DC (Dr. Dai), and School of Nursing, Johns Hopkins University, Baltimore, MD (Dr. Dai).
概括
人工智能 (AI) 和机器学习在骨科手术中正在迅速发展. 对FDA批准的设备的审查显示了越来越多的采用,但强调了改善临床评估和监管标准的必要性,以确保安全实施.
科学领域:
- 整形外科手术 整形外科手术
- 医疗设备创新 医疗设备创新
- 人工智能在医学中的应用
背景情况:
- 人工智能 (AI) 和机器学习 (ML) 具有显著的潜力,可以增强骨科手术中的医疗护理.
- 现有的研究往往侧重于未来的应用,在了解目前批准的AI/ML医疗器械 (AIMD) 方面存在差距.
- 需要对FDA批准的骨科AIMD进行全面分析,以评估当前的趋势和监管状况.
研究的目的:
- 进行对FDA批准的基于AI/ML的医疗器械 (AIMDs) 进行综合分析,用于骨科手术.
- 根据指示,子专业,AI架构和商业化战略对这些设备进行分类.
- 评估随着时间的推移,AIMD许可和临床测试要求的演变.
主要方法:
- 截至2025年2月,对70个FDA批准的骨科手术指示的AIMD进行了回顾性分析.
- 根据指示用途,骨科子专业,发展史,AI架构和商业化方法进行分类.
- 对商业化设备的制造商地位,收购历史和总部所在国的分析.
主要成果:
- 骨科的AIMD清除率急剧上升,三年移动平均水平从3.0个设备/年 (2017-2019) 增加到16.6个 (2022-2024).
- 深度学习是占主导地位的人工智能技术 (57.3%的2022-2024年批准),脊椎手术是最常见的子专业 (42.9%).
- 虽然最初的批准往往缺乏临床试验 (2017-2019年为62.2%),但这一比例显著下降 (2022-2024年为19.7%),尽管只有8.6%接受了前性试验.
结论:
- 人工智能是骨科手术中快速发展的领域,FDA批准的增加证明了这一点.
- 有一种趋势是对AIMD进行更多的临床测试,远离缺乏任何验证的设备.
- 加强监管保障和强有力的临床评估标准对于基于证据的AI在骨科的采用和安全使用至关重要.
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