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The OSTEOTRANS™-OT Pin is intended for fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses or bone grafts, for example in the fixation of apical fragments and cancellous/non-load bearing fragments in the presence of appropriate immobilization.

The OSTEOTRANS™-OT Pins are the sterile, single-use bone pins manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Pins are provided with various shapes and sizes typical of other marketed fixation devices. Used properly, in the presence of adequate immobilization, the OSTEOTRANS™-OT Pins maintain accurate alignment of bone fractures and osteotomies.

The provided text is a 510(k) summary for a medical device (OSTEOTRANS™-OT Pin) seeking substantial equivalence to predicate devices. It focuses on device description, intended use, and comparison to existing products, rather than a detailed study proving performance against acceptance criteria in the context of an AI/ML device.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not present in the provided document.

This document describes a traditional medical device (bioabsorbable bone fixation pin) and its claims of substantial equivalence based on design and material similarities to predicate devices, and performance data demonstrating requisite strength and favorable degradation profile. It does not involve a software algorithm or AI, and therefore the concepts of test sets, ground truth established by experts, MRMC studies, or standalone algorithm performance are not applicable.

The "performance data" mentioned is likely related to bench testing of the pin's mechanical properties and degradation characteristics, not a clinical study with human subjects, or a study of an AI's diagnostic accuracy.

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