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Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion implants. The size of Kirschner wire should be adapted to the specific indications

The Precifit Medical Kirschner wire is a stainless steel (316LVM) wire available with two point styles: smooth and threaded. The wires are available in various diameters (1.0 - 2.5mm) and lengths (120 -200mm). One end is fixed on standard surgical power tool equipment for insertion. The Precifit Medical Kirschner wire is supplied non-sterilized by the end user. It is intended for single use only.

This document is a 510(k) premarket notification for the Precifit Medical Kirschner Wires and does not contain information about an AI/ML powered device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, and AI/ML specific metrics.

The document pertains to a medical device (Kirschner Wires) that are physical implants used for bone fixation, not a digital health product or algorithm. The sections referring to "Non-clinical testing" and "Clinical testing" confirm that the device conforms to an international standard (ISO 5838-1 (2013)) and that clinical testing was not required to demonstrate substantial equivalence. This indicates a traditional medical device submission, not one involving AI/ML performance evaluation.

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