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The Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.

The Arthrex Univers II Shoulder Pegged Glenoid is manufactured in three sizes from UHMWPE. The glenoid articular (lateral) surface is concave and articulates with the humeral head of the Univers or Univers II humeral stems. The fixation (medial) surface is convex and is designed with three pegs for cement interdigitation fixation.

The provided text describes the Arthrex Univers II Shoulder Pegged Glenoid, a shoulder prosthesis. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of AI/ML performance.

This document is a 510(k) summary for a medical device (a shoulder prosthesis), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from a clinical or AI/ML study. The determination of substantial equivalence for a non-AI/ML device typically relies on a comparison of design, materials, manufacturing processes, and intended use with a legally marketed predicate device, rather than quantitative performance metrics from a specific study against acceptance criteria.

Therefore, I cannot provide the requested information. The document explicitly states: "The Arthrex Univers II Shoulder Pegged Glenoid is substantially equivalent to the predicate Arthrex Univers Shoulder Prosthesis in which the basic features and intended uses are the same. Any differences between the Arthrex Univers II Shoulder Pegged Glenoid and the predicate Arthrex Univers Shoulder Prosthesis or Univers II Shoulder Prosthesis are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the new Arthrex Univers II Shoulder Pegged Glenoid is substantially equivalent to the currently marketed predicate device."

This indicates that the primary "proof" of meeting safety and effectiveness is through demonstrating substantial equivalence to an existing device, not through a new performance study with acceptance criteria as typically seen for AI/ML devices.

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