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The Arthrex NanoScope system is intended to be used as an endoscopic video camera in a variety of endoscopic diagnostic and surgical procedures, including but not limited to: orthopedic, spine, laparoscopic, urologic, sinuscopic, and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.

The Arthrex NanoScope System provides image processing and digital documentation for endoscopic procedures. The system utilizes a handpiece which provides distal LED illumination to the surgical site using a fiber optic bundle surrounding a high-resolution camera sensor.

The provided text is a 510(k) premarket notification letter and summary for the Arthrex NanoScope System. It describes the device, its intended use, and arguments for substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance.

This document specifically states that:

• "Nonclinical (bench) testing was performed to demonstrate substantial equivalence to the predicate regarding thermal safety, electrical safety, optical performance, environmental conditions, power requirements, image capture, and video output and resolution."
• "An engineering analysis was performed to address the substantial equivalence of the field of view and the working diameter compared to the predicate device."

This indicates that the substantial equivalence was established through bench testing and engineering analysis for hardware performance, not through clinical studies or AI/ML performance evaluations against specific acceptance criteria. The device is an endoscopic video camera system, and the submission is to expand its indications for use (adding spine procedures) and extend the shelf life of a sterile component, not for a new AI/ML-driven diagnostic or assistive feature.

Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and study details from the provided text. The questions posed are highly relevant to AI/ML medical devices, but this document describes a traditional medical device submission (an endoscopic camera) where such metrics and studies are not typically required for regulatory clearance unless the device incorporates an AI/ML component with a diagnostic or assistive function.

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