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The Pegged All-Poly (ASTM F648) Glenoid is a one piece design intended to reproduce the function of the natural glenoid. The design of this glenoid component allows use in the right or left shoulder. The implant is cemented into the subchondral bone of the glenoid cavity providing a cement mantle of approximately 1-2 mm.

The Pegged All-Poly Glenoid Component features a flat back, two grooved pegs and a circumferential dovetail cement groove on the medial surface to provide translational and rotational stability to the implant as well as to enhance cement fixation. The peg grooves allows for intraoperative trimming in the event of shallow glenoid anatomy. The concave lateral surface of the glenoid implant accommodates the humeral head. The geometry of the component is nonconstrained. Titanium pins in the inferior and superior aspects of the component assist in postoperative evaluation.

This 510(k) summary describes a medical device (Intermedics Orthopedics, Inc. Select® Shoulder All-Poly Glenoids) and does not contain information about a study proving its performance against acceptance criteria in the context of an AI/algorithm-driven device. Therefore, I cannot extract the requested information.

The document describes a physical medical implant (a glenoid prosthesis) and discusses its design, materials, and substantial equivalence to other existing glenoid prostheses on the market. It mentions "contact area testing" but provides no details on acceptance criteria, reported performance values, study design, sample sizes, expert involvement, or any of the other AI/algorithm-specific metrics requested.

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