The integration of robotics in surgery has increased over the past decade, and advances in the autonomous capabilities of surgical robots have paralleled that of assistive and industrial robots. However, classification and regulatory frameworks have not kept pace with the increasing autonomy of surgical robots. There is a need to modernize our classification to understand technological trends and prepare to regulate and streamline surgical practice around these robotic systems. We present a systematic review of all surgical robots cleared by the United States Food and Drug Administration (FDA) from 2015 to 2023, utilizing a classification system that we call Levels of Autonomy in Surgical Robotics (LASR) to categorize each robot’s decision-making and action-taking abilities from Level 1 (Robot Assistance) to Level 5 (Full Autonomy). We searched the 510(k), De Novo, and AccessGUDID databases in December 2023 and included all medical devices fitting our definition of a surgical robot. 37,981 records were screened to identify 49 surgical robots. Most surgical robots were at Level 1 (86%) and some reached Level 3 (Conditional Autonomy) (6%). 2 surgical robots were recognized by the FDA to have machine learning-enabled capabilities, while more were reported to have these capabilities in their marketing materials. Most surgical robots were introduced via the 510(k) pathway, but a growing number via the De Novo pathway. This review highlights trends toward greater autonomy in surgical robotics. Implementing regulatory frameworks that acknowledge varying levels of autonomy in surgical robots may help ensure their safe and effective integration into surgical practice.

过去十年来，机器人技术在手术中的集成度不断提高，手术机器人自主能力的进步与辅助机器人和工业机器人的进步相当。然而，分类和监管框架并没有跟上手术机器人日益增强的自主性。有必要对我们的分类进行现代化改造，以了解技术趋势，并准备规范和简化围绕这些机器人系统的手术实践。我们对 2015 年至 2023 年美国食品药品监督管理局 (FDA) 批准的所有手术机器人进行了系统回顾，利用我们称为手术机器人自主级别 (LASR) 的分类系统对每个机器人的决策和操作进行分类。采取行动的能力从 1 级（机器人协助）到 5 级（完全自主）。我们于 2023 年 12 月检索了 510(k)、De Novo 和 AccessGUDID 数据库，纳入了符合我们对手术机器人定义的所有医疗设备。筛选了 37,981 条记录，识别出 49 台手术机器人。大多数手术机器人处于 1 级（86%），有些达到 3 级（有条件自主）（6%）。 FDA 认可 2 款手术机器人具有机器学习功能，据报道还有更多手术机器人在其营销材料中具备这些功能。大多数手术机器人是通过 510(k) 途径引入的，但越来越多的手术机器人是通过 De Novo 途径引入的。这篇评论强调了手术机器人更大自主性的趋势。实施承认手术机器人不同程度自主权的监管框架可能有助于确保其安全有效地融入手术实践。