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The NexFix™ Compression Pin is intended to be implanted for the fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis of the foot and ankle and hand and wrist.

The Nexa Orthopedics, Inc Implant is a one-piece device made of Stainless Steel or Titanium Alloy, intended for fixation of bone fractures, bone reconstruction, osteotomy or arthrodesis. The implant is designed in 10 sizes. The device is tapered and threaded on the leading end and smooth on the trailing end. The implant is used in the treatment of bone fractures or bone reconstruction, including osteotomy, and joint fusion. The design of the NexFix™ Compression Pin is similar to the predicate devices. No new materials or processes are used in the development of this implant.

This 510(k) summary describes a traditional medical device (a threaded pin for bone fixation), not an AI/ML-powered device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth for an AI device is not applicable and cannot be extracted from the provided text.

The document focuses on demonstrating substantial equivalence to predicate devices based on design characteristics, intended use, and materials. There is no mention of an algorithm, data analysis, or performance evaluation in the context of AI/ML.

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