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The Tyber Medical BioTy® Nanotopography 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. The screw is intended for single use only.

A trauma screw with BioTy® Nanotopography Surface Treatment is designed to apply compression and fixation between two adjacent segments of cortical and/or cancellous bone.

This FDA document is for a medical device called the "Tyber Medical BioTy® Nanotopography Trauma Screw." It's a 510(k) premarket notification, meaning it's seeking to demonstrate substantial equivalence to previously marketed devices, rather than proving novel effectiveness. Therefore, the information provided focuses on non-clinical testing and comparison to predicates, not on clinical trials or AI performance.

Based on the provided text, I cannot answer the questions regarding acceptance criteria and study design for AI devices because:

• This is not an AI/ML device. The document describes a trauma screw with a specific surface treatment (BioTy® Nanotopography), which is a physical medical device, not a software algorithm or an AI system.
• No clinical study to prove AI performance is mentioned. The "Clinical Test Summary" explicitly states "n/a" (not applicable), indicating that no clinical trials were conducted or reported for this submission to evaluate the device's performance in humans. The testing performed was non-clinical (mechanical, invitro, pyrogenicity) to evaluate the physical characteristics and safety of the screw itself and its surface treatment.
• Acceptance criteria for AI performance are not relevant here. The acceptance criteria discussed in the document relate to the physical properties, safety, and substantial equivalence of the trauma screw to predicate devices, not to metrics like sensitivity, specificity, F1-score, or human reader improvement with AI assistance.

Therefore, since the input document does not pertain to an AI device or a clinical study for an AI device, I cannot provide the requested information.

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