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The SOLCO 4CIS® General Plate System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femur, pelvis, metacarpals, metatarsals, humerus, ulna, radius, hand and middle foot bones.

The SOLCO 4CIS & General Plate System consists of One-third Tubular plate, Small self compression plate, Reconstruction plate (Straight, Curved), Narrow self Small Sole Compression plate. SOLCO 4CIS® General Plate. SOLCO 4CIS® General Plate comproblem participants sizes of implants to accommodate the individual byother with from pure titanium material.

The provided document is a 510(k) summary for the SOLCO 4CIS® General Plate System, a bone fixation plate. It details the device, its intended use, and substantial equivalence to predicate devices. However, this document does not contain the information requested in the prompt regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Performance Data" section merely states: "Mechanical testing was conducted in accordance with ASTM F382 and Nicenames." This indicates that some form of performance testing was done, but it does not provide specific acceptance criteria or the results of those tests.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory submission details and intended use, not on the specifics of a performance study with detailed acceptance criteria and results.

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