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ReFIX Screws are intended for use in the fixation and/or alignment of fragments of fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or alignment of apical fragments, osteochondral fragments and cancellous/non-load bearing bone fragments.

For example, ReFIX Screws are intended for use in fractures of the ankle, colles, distal radius, hand and wrist, humeral condyle, malleolus, metacarpals, olecranon, phalanges and the radial head; fusions of metacarpals, metatarsals and phalanges; and correction of hallux valgus.

ReFIX™ Screws are comprised of Internal Fracture Fixation Devices based upon biodegradable polymer fixation systems. Biodegradable polymers are widely used in the orthopaedic specialty. The ReFIX Screws are manufactured from PLLA and PLGA. The Screws are available in diameters ranging from 2.7mm to 6.0mm. ReFIX Screws are available in lengths ranging from 30mm to 60mm. The Screws are sized and trimmed intraoperatively using the ReFIX instrumentation according to the surgical technique. The sizes and materials are designed to address the indications cited.

I'm sorry, but this document does not contain the information requested. This document is a 510(k) summary for a medical device (ReFIX™ Internal Fixation Screws), which primarily focuses on establishing substantial equivalence to previously approved predicate devices.

The information you are requesting, such as acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity), sample sizes for test and training sets, details about ground truth establishment, expert qualifications, and specific study designs (like MRMC or standalone studies), is typically found in detailed study reports or clinical trial summaries, which are not provided in a 510(k) summary focused on substantial equivalence.

A 510(k) summary generally demonstrates that a new device is as safe and effective as a legally marketed predicate device, often by comparing materials, intended use, and operational principles, rather than providing detailed performance metrics from a specific study against predefined acceptance criteria.

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