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The Synthes Peri-Prosthetic Screws are intended for fixation of various long bones, such as the humerus, femur and tibia, in conjunction with Synthes locking plates that accept 4.0/5.0 mm locking screws. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and fixation of non-unions or malunions.

The new Synthes 4.0/5.0mm Peri-prosthetic Locking Screws feature a self-tapping blunt tip, stardrive mechanism, and have a flat head profile with rounded edges. They are available in lengths ranging from 8mm to 12mm. The threads on the head of each locking screw are designed to engage with the threaded holes of currently marketed Synthes LCP® plating systems.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) summary and FDA clearance letter for the "Synthes Peri-Prosthetic Screws," which details the device description, intended use, classification, and substantial equivalence to predicate devices, but does not include the specifics of performance testing or clinical studies to meet acceptance criteria.

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