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The Arthrex NanoScope System is intended to be used as an endoscopic video camera to provide visible light imaging in a variety of endoscopic diagnostic and surgical procedures, including laparoscopy, orthopedic, plastic surgery, sinuscopy, spine, and urology. The device is also intended to be used as an accessory for microscopic surgery.

For pediatric patients, the Arthrex NanoScope System is indicated for use in laparoscopy and orthopedic procedures.

The Arthrex NanoScope System provides real-time visible light illumination and imaging. The system includes a non-sterile reusable camera control unit (CCU) console and sterile disposable camera handpieces. The system integrates high-definition camera technology, LED lighting, and an imaging management system into a single console with touchscreen interface.

The provided document describes the Arthrex NanoScope System, a medical device used for endoscopic video imaging. However, this document does not contain information about a study proving the device meets specific acceptance criteria related to a specific performance metric (e.g., accuracy, sensitivity, specificity) for an AI/ML algorithm that identifies or classifies something.

The performance data section (pages 5 and 6) outlines various non-clinical bench testing, including:

• Biocompatibility testing: Performed according to ISO 10993 standards.
• Electrical, Mechanical, and Thermal (EMT) safety testing: Performed according to ANSI/AAMI ES60601-1 and IEC 60601-2-18 standards.
• Electromagnetic Compatibility (EMC) testing: Performed according to IEC 60601-1-2 standards.
• Software testing: Performed according to FDA guidance and IEC 62304.
• Design verification testing: Included inspection, engineering analysis, and functional testing.

These tests confirm the device's conformance to safety, performance, and software quality standards relevant to an endoscopic imaging system, rather than demonstrating the performance of an AI model against specific clinical metrics like sensitivity or specificity. The submission aims to expand indications and report software and device modifications, relying on equivalence to predicate devices rather than a de novo clinical study proving AI performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML algorithm's performance, as the provided text does not describe such a study. The document explicitly states: "The Arthrex NanoScope System did not require animal testing or human clinical studies to support the determination of substantial equivalence." This further indicates that no clinical performance study, particularly one involving AI/ML and human-in-the-loop or standalone performance, was conducted as part of this submission.

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