人工智能 (AI) 在牙科的发展趋势:探索FDA批准的牙科设备
Nighat Naved1, Samira Adnan2, Fahad Umer3
1Aga Khan University Hospital, Karachi, Pakistan.
BMC oral health
|November 29, 2025
概括
人工智能 (AI) 和机器学习 (ML) 牙科设备越来越多地得到FDA的批准,其中大多数专注于成像诊断. 为了安全地采用这些AI/ML牙科技术,需要更大的透明度和现实世界的验证.
科学领域:
- 牙科 牙科是指牙科的专业.
- 医疗成像医学成像
- 人工智能的人工智能
背景情况:
- 人工智能 (AI) 和机器学习 (ML) 越来越多地被整合到牙科中,以改善诊断和治疗计划.
- 监管部门的批准,特别是通过美国食品和药物管理局 (FDA) 510(k) 途径,对于AI/ML牙科设备的安全和有效临床采用至关重要.
研究的目的:
- 分析由FDA批准的基于AI/ML的牙科设备的趋势和特征.
- 了解AI/ML牙科技术整合到临床实践中的情况.
主要方法:
- 在2024年12月,对FDA的510 (k) 预售通知数据库进行了手动搜索.
- 使用的关键词包括"AI/ML设备"和"牙科",并提取了设备类型,批准年,临床适应症和来源的数据.
主要成果:
- 确定了52种AI/ML牙科设备,在2022年获得批准的数量最高 (15.38%).
- 口腔放射学 (48%) 占主导地位,其次是植入物学和再生手术 (32%).
- 大多数设备来自美国 (46.15%),但很大一部分 (60%) 没有披露AI/ML算法,50%缺乏公共部署数据.
结论:
- 大多数FDA批准的AI/ML牙科设备用于成像诊断.
- 提高对算法的透明度和强大的现实世界验证对于人工智能在牙科安全整合至关重要.
- 公平的考虑对于AI/ML牙科技术的广泛采用是必要的.
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