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Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.

External fixation devices are specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.

The provided text describes the reprocessed external fixation devices, their intended use, and substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical or comparative effectiveness studies involving human readers or standalone algorithm performance.

Instead, the document details "bench and laboratory testing" to demonstrate performance (safety and effectiveness) and that the "Reprocessed External Fixation Devices perform as originally intended." However, it does not provide specific metrics, sample sizes, or methodologies for this testing beyond "Validation of reprocessing" and "Function Testing."

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document focuses on regulatory approval (510(k) summary) based on substantial equivalence, rather than a detailed performance study with quantifiable acceptance criteria.

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