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The Hammerdesis™ Interphalangeal Fusion System is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.

The Hammerdesis™ Interphalangeal Fusion system is composed of a counter rotation ring implant, recovery dowel and K-wire to be used in conjunction with a peg and hole fusion of the phalanges. The implant comes in two different sizes to accommodate differing anatomies. The counter rotation ring has axial spikes that prevent either side of the joint from rotating and allow fusion of the joint.

The provided text is a 510(k) summary for the Hammerdesis™ Interphalangeal Fusion System, a medical device. This document focuses on demonstrating the substantial equivalence of the device to existing predicate devices, primarily through mechanical performance testing.

It does not contain information about an AI/ML-driven device or diagnostic study. Therefore, I cannot provide a response addressing acceptance criteria and study details related to AI/ML device performance, such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document describes the device, its indications for use, technological characteristics, and performance data related to its mechanical properties. The performance data section states:

"The subject Hammerdesis™ Interphalangeal Fusion System was evaluated in static torsion test, static and dynamic cantilever bend testing, and axial pullout. The subject device demonstrated superior performance in comparison to that of the predicate (K131459); therefore, the subject device mechanical performance is considered substantially equivalent to the predicate (K131459)."

This indicates that the acceptance criteria for this device are based on its mechanical equivalence or superiority to the specified predicate device in these specific tests, rather than diagnostic accuracy metrics.

To answer your request, the provided document would need to be about a diagnostic AI/ML device, which it is not.

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