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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 Prosthesis consists of a stem for attachment to the humerus, a spherical head for replacing the humeral head, and a trunnion construct to connect the stem to the spherical head. The modified device is identical to the cleared predicate (K010124) except for how it addresses two of the three key angles that can be adapted to match the geometry of the humeral head.

This is a 510(k) summary for a medical device, the Arthrex Univers II Shoulder Prosthesis, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and training sets is not applicable in the context of AI/ML performance evaluation.

This document describes a medical device submission based on "substantial equivalence" to a predicate device (Arthrex Shoulder Prosthesis (Univers Shoulder), K010124). For devices cleared via 510(k), particularly those seeking substantial equivalence to a predicate, the "study" demonstrating that the device meets "acceptance criteria" often refers to non-clinical testing (e.g., mechanical, materials, biocompatibility) and a comparison of the new device's characteristics and intended use to those of the predicate device. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Therefore, I cannot provide the requested information as it is not present in the provided text, nor would it typically be part of a 510(k) for a non-AI medical implant.

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