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The Synthes 2.4/2.7 mm Locking Foot Module is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including the foot and ankle, particularly in osteopenic bone.

Synthes 2.4/2.7 mm Locking Foot Module consists of locking foot plates of various shapes and sizes to accommodate patient anatomy and orthopedic conditions in the foot and ankle. The plates are attached to bone via 2.4 and 2.7 mm cortex and locking screws.

This is a 510(k) summary for a medical device (Synthes USA 2.4/2.7mm Locking Foot Module), which primarily focuses on establishing substantial equivalence to a predicate device based on design, materials, and intended use. It does not contain information about studies related to software algorithm performance, acceptance criteria for an AI/CADe system, or clinical study data for device performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving device performance in the context of an AI/CADe system. The document does not describe such a study or performance metrics.

In summary, none of the requested information (points 1-9) can be extracted from the provided text because it pertains to a traditional hardware medical device clearance, not an AI/CADe device.

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