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The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

General trauma screw for compression and fixation of bone. This submission adds a headed screw and snap off option as well as an optional washer to the previously cleared headless trauma screw with and without previously cleared modified surface treatment. The screws will be provided sterile and non-sterile in both solid and cannulated form, made of from titanium (with and without Modified Surface treatment) and

The provided document is a 510(k) summary for the Tyber Medical Trauma Screw. It describes the device's characteristics, intended use, and substantial equivalence to a predicate device, but it does not contain information about the acceptance criteria or a study proving that a device meets those criteria in the context of an AI/ML medical device.

The document pertains to a physical medical device (trauma screw) and primarily focuses on demonstrating substantial equivalence through non-clinical testing of mechanical properties, specifically static torsion. There is no mention of an algorithm, AI, or machine learning model.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies proving an AI/ML device meets them based on the provided text. The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are highly specific to AI/ML device evaluations and are not applicable to the content of this 510(k) summary for a trauma screw.

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