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The Trabecular Metal™ Reverse Shoulder System Vivacit-ETM Vitamin E Highly Crosslinked Polyethylene Liners are indicated for:

• the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint;
• ununited humeral head fractures of long duration;
• irreducible 3-and 4-part proximal humeral fractures;
• avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.

The Zimmer Trabecular Metal Reverse Shoulder System Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners are a series of liners manufactured from Vitamin E (a-tocopherol) blended, highly crosslinked ultrahigh molecular weight polyethylene (HXPE) and are designed for use with the Zimmer Trahecular Metal (TM) Reverse Shoulder System in the reverse shoulder application. The liners provide a bearing interface between the TM Reverse Humeral Stem and the glenosphere component. They are offered in two different diameters (36mm and 40 mm) and three thicknesses (+0mm, +3mm and +6mm). The liners are also offered as either 60° standard liners or 65° retentive liners. The retentive liners cover a larger surface of the glenosphere component.

The provided text is a 510(k) summary for the Zimmer® Trabecular Metal™ Reverse Shoulder System, specifically focusing on the Vivacit-ETM Vitamin E Highly Crosslinked Polyethylene Liners. It is a regulatory submission to the FDA, not a study report for an AI/ML medical device. Therefore, it does not contain the information requested about acceptance criteria, device performance from a test set, ground truth establishment, or clinical study details for an AI/ML device.

The document indicates that clinical performance data was not needed for this device, as it is a modification of an already cleared device. The "Non-Clinical Performance and Conclusions" section describes laboratory testing for the physical components of the shoulder system (e.g., locking mechanism, torque, fatigue, wear), which are not measures of AI/ML device performance.

Therefore, I cannot provide the requested information based on the given text.

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