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The EzFuze Implants have the following Indications for Use:
Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.

The Vilex EzFuze Implant System includes single-piece devices intended for the fixation of PIP joints in lesser toes and digits. Two styles are offered: EzFuze Implant with barbed prongs on both ends and Hybrid EzFuze Implant with a screw design at one end and the other end includes barbed prongs. The EzFuze and Hybrid EzFuze Implants are offered straight or with a 10° bend.

This document is a 510(k) summary for the EzFuze™ Implant System. It outlines the device's indications for use, technological characteristics, and its substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance metrics, or any study details that would typically be described in an AI/algorithm-based device submission.

This is a submission for a physical medical device (an implant for bone fixation), not an AI-powered software or diagnostic tool. Therefore, the questions related to AI device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to the content provided.

Based on the provided text, I cannot provide the requested information because the document describes a physical medical implant, not an AI software/device.

To answer your request, I would need a document related to an AI/algorithm-based medical device.

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