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The Arthrex Bio-Transfix is intended to provide ACL graft fixation in the femur in orthopaedic procedures.

The Arthrex Bio-Transfix, composed of poly(L-lactide), is a cannulated pin having a diameter of approximately 5 mm and an overall length of 50 mm. One end is tapered 11.684 mm to a minor diameter of 1.422 mm. The other end has three barbs for cortical fixation and a spherical fitting for its driver.

The provided text is a 510(k) premarket notification for the Arthrex Bio-Transfix device, a non-metallic fixation pin for ACL graft fixation. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies.

Therefore, the requested information regarding acceptance criteria, study details, and performance metrics for the device in isolation (i.e., standalone performance, MRMC studies, sample sizes for test/training sets, expert qualifications, adjudication methods, and ground truth establishment) is not present in the provided document.

The document states that:

"The differences between the Arthrex Bio-Transfix and the predicate device do not raise any different questions regarding safety and effectiveness. Furthermore, the material is well characterized, and has been used in predicate devices with similar indications. The device, as designed, is as safe and effective as the predicate devices."

This indicates that the acceptance criteria for this 510(k) submission revolve around demonstrating material characterization and similarity to existing, legally marketed predicate devices that have already established their safety and effectiveness. The study to "prove the device meets the acceptance criteria" in this context is the substantive equivalence comparison presented in the 510(k) summary, rather than independent clinical trials with specific quantitative performance targets.

In summary, none of the requested detailed information regarding acceptance criteria, study design, performance metrics, ground truth, or expert involvement can be extracted from this 510(k) submission because its purpose is to demonstrate substantial equivalence, not to conduct a de novo performance study against explicit acceptance criteria.

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