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Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

The Arthrosurface Bone Screws have a diameter of 2.0/2.7 mm and are made available in lengths varying from 8 mm to 24 mm with 2 mm increments. The bone screws have a snap-off feature and are designed to work with a powered wire driver, and are manufactured from implant grade stainless steel or titanium allov.

The provided text describes a 510(k) premarket notification for Arthrosurface Bone Screws and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The document is a traditional 510(k) submission for a physical medical device (bone screws), where substantial equivalence to a predicate device is demonstrated through comparisons of indications, materials, and non-clinical tests like a pyrogenicity test. It does not mention any AI/ML components, comparative effectiveness studies (MRMC), standalone algorithm performance, or the involvement of experts for establishing ground truth as would be relevant for AI/ML devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance as it pertains to AI/ML devices from this text.

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