Levels of autonomy in FDA-cleared surgical robots: a systematic review

Levels of autonomy in FDA-cleared surgical robots: a systematic review

2024 | Audrey Lee, Turner S. Baker, Joshua B. Bederson, Benjamin I. Rapoport
The article presents a systematic review of surgical robots cleared by the United States Food and Drug Administration (FDA) from 2015 to 2023, using a classification system called Levels of Autonomy in Surgical Robotics (LASR). The LASR scale categorizes surgical robots based on their decision-making and action-taking abilities from Level 1 (Robot Assistance) to Level 5 (Full Autonomy). The review identified 49 unique surgical robots, with most (86%) classified as Level 1 and some reaching Level 3 (Conditional Autonomy) (6%). Two robots were recognized by the FDA for machine learning capabilities, while more were reported in marketing materials. Most robots were introduced via the 510(k) pathway, but a growing number via the De Novo pathway. The review highlights trends toward greater autonomy in surgical robotics and emphasizes the need for regulatory frameworks that acknowledge varying levels of autonomy to ensure safe and effective integration into surgical practice. The authors suggest that a unified framework tailored to surgical robotics is necessary to develop regulatory standards and practice parameters, addressing legal and ethical considerations.The article presents a systematic review of surgical robots cleared by the United States Food and Drug Administration (FDA) from 2015 to 2023, using a classification system called Levels of Autonomy in Surgical Robotics (LASR). The LASR scale categorizes surgical robots based on their decision-making and action-taking abilities from Level 1 (Robot Assistance) to Level 5 (Full Autonomy). The review identified 49 unique surgical robots, with most (86%) classified as Level 1 and some reaching Level 3 (Conditional Autonomy) (6%). Two robots were recognized by the FDA for machine learning capabilities, while more were reported in marketing materials. Most robots were introduced via the 510(k) pathway, but a growing number via the De Novo pathway. The review highlights trends toward greater autonomy in surgical robotics and emphasizes the need for regulatory frameworks that acknowledge varying levels of autonomy to ensure safe and effective integration into surgical practice. The authors suggest that a unified framework tailored to surgical robotics is necessary to develop regulatory standards and practice parameters, addressing legal and ethical considerations.
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