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The Exactech® Equinoxe® PHx® Fracture System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Specific clinical indications for ORIF are as follows: fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The 3.5mm diameter Exactech® EPIC Screws of the Epic Extremity Plate System (cleared under K153340) are also intended for use with the Exactech® Equinoxe® PHx® Fracture System for Open Reduction Internal Fixation procedures of the proximal humerus.

The Exactech® Equinoxe® PHx® Fracture System is a set of plate and screw components for use in Open Reduction Internal Fixation (ORIF) applications for fractures of the proximal humerus. The Exacteche Equinoxe® PHx® Fracture System includes various sizes of fracture plates and fixation screws and is to be used with the 3.5mm diameter Exactech® EPIC locking and non-locking style screws (cleared under K153340). The Exactech® Equinoxe® PHx® Fracture System with the Exactech® EPIC Screws are intended to be used for internal fixation of fractures, fracture dislocations, non-unions, and osteotomies of the proximal humerus.

The Exactech® EPIC Screws were previously cleared with the Epic Extremity Plate System with an indication for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. This is an indication change only for the 3.5mm EPIC locking and non-locking screws.

This 510(k) summary describes a medical device, the Exactech® Equinoxe® PHx® Fracture System with Exactech® EPIC Screws, and its substantial equivalence to predicate devices, but it does not include information about acceptance criteria and a study proving device meets acceptance criteria in the way typically expected for an AI/software as a medical device (SaMD) submission.

This document is for a physical orthopedic implant (plate and screw system for bone fixation), not an AI or software device. The "performance criteria" and "testing" described are for mechanical and biocompatibility aspects of the physical hardware, not for diagnostic accuracy, sensitivity, specificity, or other performance metrics usually associated with AI/SaMD.

Therefore, I cannot provide the requested information in the format specific to AI/SaMD for this document. The concepts of "test set," "training set," "ground truth," "experts for ground truth," "adjudication method," and "MRMC comparative effectiveness study" are not applicable to the information provided in this 510(k) summary for a physical orthopedic device.

If you have a document related to an AI/SaMD, I would be happy to analyze it for the requested information.

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