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Area of Science:

  • Orthopaedic Surgery
  • Medical Device Innovation
  • Artificial Intelligence in Medicine

Background:

  • Artificial intelligence (AI) and machine learning (ML) offer significant potential to enhance medical care in orthopaedic surgery.
  • Existing research often focuses on future applications, leaving a gap in understanding currently approved AI/ML medical devices (AIMDs).
  • A comprehensive analysis of FDA-cleared AIMDs in orthopaedics is needed to assess current trends and regulatory status.

Purpose of the Study:

  • To conduct a comprehensive analysis of FDA-cleared AI/ML-based medical devices (AIMDs) for orthopaedic surgery.
  • To categorize these devices by indication, subspecialty, AI architecture, and commercialization strategy.
  • To evaluate the evolution of AIMD clearances and clinical testing requirements over time.

Main Methods:

  • Retrospective analysis of 70 FDA-cleared AIMDs for orthopaedic surgery indications as of February 2025.
  • Categorization based on indicated use, orthopaedic subspecialty, development history, AI architecture, and commercialization approach.
  • Analysis of manufacturer status, acquisition history, and country of headquarters for commercialized devices.

Main Results:

  • AIMD clearances in orthopaedics have surged, with a 3-year moving average increasing from 3.0 devices/year (2017-2019) to 16.6 (2022-2024).
  • Deep learning is the dominant AI technique (57.3% of 2022-2024 approvals), with spine surgery being the most common subspecialty (42.9%).
  • While initial clearances often lacked clinical testing (62.2% from 2017-2019), this rate decreased significantly (19.7% from 2022-2024), though only 8.6% underwent prospective trials.

Conclusions:

  • AI is a rapidly growing field in orthopaedic surgery, evidenced by increasing FDA clearances.
  • There is a trend towards greater clinical testing of AIMDs, moving away from devices lacking any validation.
  • Enhanced regulatory safeguards and robust clinical evaluation standards are crucial for the evidence-based adoption and safe use of AI in orthopaedics.