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The LTJ Screws (3.75mm solid and 4.5mm cannulated) are intended to be used in skeletally mature patient as stand-alone bone screws for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Optional washers are available for the 3.75 solid screws.

The purpose of this Special 510(k) is to add additional references to the LTJ Screws and Washer system. These new references are provided in titanium alloy compliant with ASTM F136 and have the same design and dimensions as the cleared LTJ Screws and Washer provided in stainless steel alloy compliant with ASTM F138. The LTJ Screws are partially threaded solid headless 3.75 mm screws and partially threaded cannulated headed 4.5 mm screws provided in various length ranging from 26 mm to 50 mm. The headless implants can be associated to an LTJ diameter 8 mm Washer. It is essential to handle and insert implants with LTJ instruments specifically designed for this purpose.

I am sorry, but the provided text only contains regulatory information about AzurMeds Inc.'s LTJ Screws and Washer, including its classification, indications for use, and a comparison to predicate devices. It mentions that "Mechanical testing was performed under ASTM F543 requirements" and that "These tests showed the subject device to be substantially equivalent in terms of performance to the predicate LTJ Screws and Washer (K200987)."

However, the document does not contain any information about acceptance criteria, detailed study results, sample sizes for test or training sets, expert qualifications, or adjudication methods. Therefore, I cannot generate the requested table and information about the device's performance against acceptance criteria.

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