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The PRO-TOE® Hammertoe Fixation Systems are indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Cannulated Implants in the PRO-TOE® Hammertoe Fixation Systems, with the PRO-TOE® X-FLEX, can be used with Implantable K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The Implantable K-Wres are indicated for use in fixation of bone reconstructions, and as guide pins for insertion of other implants. Additionally, Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toe following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.

The PRO-TOE® X-FLEX Hammer Fixation System is a super-elastic, nitinol device which provides active compression across the proximal interphalangeal joint (PIPJ). Unlike competitive nitinol devices on the market, the PRO-TOE® X-FLEX may be stored at room temperature, eliminating the need for freezer storage.

The device is offered in 3 sizes both available in 0° and 10° angulations. The implant is provided sterile and pre-packaged with a K-wire and Pusher instrument. The Pusher instrument is a polycarbonate molded component which is used to perform the final seating of the implant to a pre-determined depth.

This document describes the PRO-TOE® X-Flex Hammertoe Fixation System, a medical device. It does not contain information related to software or AI performance. The provided text is a 510(k) summary for a medical device submitted to the FDA for market clearance. The information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is typically associated with evaluating the performance of AI/ML-driven diagnostic devices or algorithms rather than implantable hardware.

Since the device is a physical fixation system for hammertoes and not a diagnostic or AI-powered tool, the requested information categories are not applicable to the content of this document. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical evidence, specifically performance testing (static and fatigue bend testing, localized corrosion resistance testing), manufacturing materials, and design characteristics. It explicitly states "N/A" for clinical evidence.

Therefore, I cannot extract the requested information from the provided text as it pertains to AI/ML device evaluation.

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