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The Synthes (USA) Modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

The Synthes (USA) Modular Mini Fragment LCP System includes 2.0, 2.4, and 2.7 mm size implants. The system incorporates a series of locking compression plates and screws of varying lengths, thicknesses, and configurations including straight, condylar, T-, Y-, adaption plates. These plates are attached to bone via 2.0, 2.4, and 2.7 mm cortex and locking screws.

This looks like a 510(k) premarket notification for a medical device. Based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria.

The document is a submission for the "Synthes (USA) Modular Mini Fragment LCP System," and it focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against specific acceptance criteria through a clinical or performance study as would be described for a diagnostic AI device.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, or MRMC studies for this document. These types of studies and details are typically requested for AI/ML-driven diagnostic devices, which this product (a bone fixation system) is not.

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