FDA-approved surgical robots trend toward autonomy, study finds

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A caller reappraisal published successful nan diary npj Digital Medicine examines nan existent categories of surgical robots that person been approved by nan United States Food and Drug Administration (FDA) based connected Levels of Autonomy successful Surgical Robotics (LASR).

 Gorodenkoff / Shutterstock.com Study: Levels of autonomy successful FDA-cleared surgical robots: a systematic review. Image Credit: Gorodenkoff / Shutterstock.com

About surgical robots

The first surgical robot to person FDA clearance was nan Automated Endoscopic System for Optimal Positioning (AESOP) successful 1993. Through nan 510(k) Premarket Notification pathway, AESOP was assigned mean consequence and classified arsenic a Class II surgical device.

Compared to nan da Vinci Surgical System by Intuitive Surgical, successful which nan surgeon uses nan robotic limb to widen his reach, modern surgical robots are much analyzable and autonomous. For example, nan TSolution One is some nan planner and operator, whereas nan surgeon is responsible chiefly for supervising nan instrument.

To date, location remains nary defined level to categorize these different systems. Currently, nan only measurement to categorize these instruments is by utilizing nan strategy applied for business robots and self-driving vehicles.

Since 2015, nan FDA has advocated for nan word “robotically-assisted surgical devices” to stress that each cleared systems person nary robotic autonomy, arsenic they require nan surgeon’s nonstop and continuous control. The surgeon is wholly responsible for nan information of nan procedure.”

The automation of surgical robots is quickly progressing, arsenic is dependence connected artificial intelligence, specifically instrumentality learning (ML). As these systems proceed to advance, concerns regarding nan ineligible work for automated surgical procedures person emerged, arsenic good arsenic whether nan surgeon aliases robot tin beryllium considered responsible. It is besides important to find which competencies are required for further training earlier these devices tin beryllium used.

About nan study

The authors of nan existent study stress nan request for azygous definitions and standards for surgical robotics crossed regulatory, standards, and aesculapian organizations and bodies. The existent study besides examines nan comparative publication of nan surgeon and instrumentality during surgical procedures.

The reappraisal included each Class II surgical robots approved by nan FDA since 2015. Each robot was examined utilizing LASR criteria for autonomy classification.

What did nan study show?

A full of 49 unsocial surgical robots were identified, 86% of which were Level 1 systems operated continuously by nan surgeon and are different referred to arsenic 'Robot Assistance.' Four Level 2 'Task Autonomy' systems, which were designed done programming to execute a circumstantial surgical task autonomously, were besides identified.

Three Level 3 systems, presently nan astir autonomous FDA-approved systems, were identified. These systems grounds 'Conditional Autonomy,' arsenic they tin scheme nan process if presented pinch circumstantial diligent details. No Level 4 aliases Level 5 surgical robots were found; however, nan researchers talk nan anticipation of abrupt drastic shifts successful autonomy pinch comparatively insignificant technological advances.

Predicate creep - a repetitive rhythm of exertion changes betwixt 510(k) clearances that whitethorn consequence successful nan abrupt preamble of devices pinch precocious levels of complexity - has been identified successful surgical robotics.”

The first 15 robotic systems received clearance earlier 2015 and were subsequently approved for further capabilities. Thereafter, 24 robots were introduced from Level 1 to Level 3. Throughout this period, task automation increased, pinch mostly Level 2 robots introduced since 2017.

When classified by nan regulatory system, astir 90% of surgical robots received 510(k) clearance, whereas nan remaining systems were approved done nan De Novo pathway. Clinical testing information was supplied for regulatory support successful 19 cases, including each Level 3, 75% of Level 2, and 30% of Level 1 robots.

Two of nan robots claimed to person ML-enabled capabilities connected their websites; however, their FDA summaries lacked grounds of these claims.

When examined by specialty, orthopedic assistive robots targeting nan spine, knee, and hep comprised astir 33% of each caller systems. One of nan 3 precocious Level 3 systems was successful orthopedics for bony milling. Robotic systems for urology, wide surgery, and neurosurgery were besides identified.

Conclusions

In nan future, LASR-based frameworks will beryllium basal to guarantee that much autonomous devices meet support criteria emphasizing objective safety. Another anticipation is that each early advances successful autonomy will participate Class III aliases high-risk devices, frankincense making premarket support mandatory.

Although this whitethorn inhibit accelerated innovation, these processes will guarantee that stringent information standards are followed successful nan support of these caller devices. Importantly, because of these extended support processes, nan costs and long of these support processes whitethorn besides increase.

The usage of ML could origin important errors to look by repetitively strengthening biased decision-making based connected training data. This could go peculiarly concerning erstwhile automated tasks are performed.

The surgical mounting is cardinal to decision-making and consequence determination. Therefore, further investigation is needed to see nan objective business and nan robotics system's level of autonomy erstwhile determining risk.

Implementing regulatory frameworks that admit varying levels of autonomy successful surgical robots whitethorn thief guarantee their safe and effective integration into surgical practice.”

Journal reference:

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