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For illumination during surgery. Regular Monofilament - Inserts into any standard Fiberoptic Pic Set. Fine Monofilament - Inserts into any standard Fiberoptic Forceps.

The American Medical Devices Endolight™ Regular and Fine Monofilaments are for illumination during surgery. The Regular Monofilament inserts into any standard pic set. The Fine Monofilament inserts into any standard fiberoptic forceps. These fibers allow the surgeon to use bi-manual technique during surgical procedures. The devices are identical except for the fact that the Regular Monofilament is a 19 ga. fiber and the Fine Monofilament is a 20 ga. fiber.

This is a 510(k) premarket notification for a medical device (fiberoptic monofilaments for surgical illumination), not an AI/ML device. Therefore, the provided text does not contain information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement typically associated with evaluating AI/ML device performance.

The document focuses on demonstrating substantial equivalence to predicate devices, sterilization methods, and material descriptions. It does not involve any algorithm performance, human-in-the-loop studies, or standalone algorithm evaluations.

As such, I cannot extract the requested information regarding AI/ML device performance and evaluation from this document.

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