Exploring Levels of Autonomy in FDA-Cleared Surgical Robots: A Systematic Review

The field of surgical robotics has seen rapid advancements in recent years, with the development of more complex and autonomous systems. A recent study published in the journal npj Digital Medicine provides a comprehensive review of the current categories of FDA-approved surgical robots based on their Levels of Autonomy in Surgical Robotics (LASR).

The study identified a total of 49 unique surgical robots that have received FDA clearance, with the majority of them falling under Level 1 systems, where the surgeon operates the robot continuously. However, there were also Level 2 and Level 3 systems identified, which demonstrated varying degrees of task autonomy.

One of the key findings of the study was the concept of predicate creep, where technology changes between 510(k) clearances may result in sudden shifts in the complexity of devices. This highlights the need for uniform definitions and standards for surgical robotics to ensure their safe and effective use in clinical practice.

The study also discussed the implications of introducing more autonomous devices into surgical practice, as well as the potential legal and ethical considerations surrounding the use of artificial intelligence and machine learning in surgical robotics.

Moving forward, the authors emphasize the importance of implementing regulatory frameworks that acknowledge the varying levels of autonomy in surgical robots to ensure their safe integration into surgical practice. By establishing clear guidelines and standards, we can mitigate risks and ensure that these innovative technologies are used responsibly in patient care.

As surgical robotics continue to evolve and become more autonomous, it is crucial that regulatory bodies, medical organizations, and healthcare professionals work together to establish guidelines that prioritize patient safety and efficacy. This study sheds light on the current landscape of surgical robotics and sets the stage for future advancements in this rapidly evolving field.

Reference:
Lee, A., Baker, T. S., Bederson, J. B., & Rapaport, B. I. (2024). Levels of autonomy in FDA-cleared surgical robots: a systematic review. npj Digital Medicine. doi:10.1038/s41746-024-01102-y.