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The Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Screws are intended for fracture fixation of large bones and large bone fragments including femoral necla fractures; slipped capital femoral epiphyses; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodeses.

The Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Screws (SCFE) have a cannulated shaft, are self-tapping with a cancellous thread that can be guided into position via a 2.8 mm guide wire, and range in overall lengths from 45 mm - 130 mm, and have 10 mm and 20 mm thread lengths. Oval washers of 1 mm and 2 mm are also available to use with the screws for precise depth placement in bone. The screws and washers are available in stainless steel.

I am sorry, but the provided text is a 510(k) summary and associated FDA correspondence for a medical device (Synthes 7.3 mm Cannulated Slipped Capital Femoral Epiphysis Screws). This type of document focuses on establishing substantial equivalence to a predicate device based on similar design, materials, and intended use, rather than presenting a performance study with acceptance criteria and detailed quantitative results as would be typical for an AI/algorithm-based device.

Therefore, the requested information for acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, and comparative effectiveness studies is not present in this document. This document does not describe a study that uses AI or an algorithm.

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