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The Small Fragment Locking Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

The technological characteristics of the Small Fragment Locking Plating System are the same as the predicate devices including design and material.

The provided text is a 510(k) summary for the "Small Fragment Locking Plating System." This document is a regulatory submission for a medical device and, as such, does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it typically include detailed performance metrics or clinical study results in the format requested.

510(k) submissions primarily focus on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies. The document states:

• "The technological characteristics of the Small Fragment Locking Plating System are the same as the predicate devices including design and material."
• "The Small Fragment Locking Plating System is substantially equivalent to the currently marketed Synthes and DePuy devices. No new issues of safety or efficacy have been raised."

Therefore, I cannot extract the information requested for acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from this document. These types of details would typically be found in engineering validation reports, biocompatibility testing reports, or potentially clinical study data if "new issues of safety or efficacy" were raised, which is stated not to be the case here.

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