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The Flex-Thread™ Ulna Intramedullary Nail System is intended for use in the fixation of fractures and osteotomies of the ulna.

The Flex-Thread™ Ulna Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the intramedullary canal of the ulnar diaphysis from an antegrade approach and cortical screws to provide stability and articular support in the proximal ulna and olecranon.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria for software or AI/ML.

The document is a 510(k) premarket notification for a medical device called "Flex-Thread™ Ulna Intramedullary Nail System". It focuses on establishing substantial equivalence to a predicate device through mechanical testing, not through performance metrics of a software or AI/ML component.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications, as these are not discussed in the context of the provided text. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states that "[n]on-clinical performance testing demonstrates that the Flex-Thread™ Una Intramedullary Nail System is substantially equivalent to the predicate device." The tests mentioned are mechanical tests such as static four-point bend, static torsion, bending fatigue, and bending fatigue of interlocking screws, along with insertion torque and implant tip deflection. These are physical product performance tests, not AI/ML performance evaluations.

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