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The Arthrex Univers Revers Modular Glenoid System is in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's ioint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.

The Arthrex Univers Revers Modular Glenoid System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

The Arthrex Univers Revers Modular Glenoid System is porous coated and is intended for cementless use with the addition of screws for fixation.

The Arthrex Univers Revers Modular Glenoid System cleared under K173900 consists of a monoblock or modular baseplate that is centrally anchored by a central screw or post for cementless use with peripheral screws, a glenosphere, and humeral insert as part of the Univers Revers Shoulder Prosthesis System, K142863.
This Special 510(k) introduces size 45 glenospheres manufactured from Cobalt Chromium (CoCr) and as well as combination humeral inserts manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE), same materials as K173900.

The provided text is an FDA 510(k) Summary for the Arthrex Univers Revers Modular Glenoid System. It describes the device, its indications for use, and how it was determined to be substantially equivalent to a predicate device.

However, this document does NOT contain information about a study proving the device meets acceptance criteria for an AI/ML-enabled medical device.

The 510(k) summary focuses on the mechanical and material properties of the shoulder prosthesis components (glenospheres and humeral inserts). The acceptance criteria and "study" described are related to:

• Mechanical testing: Fatigue testing, corrosion testing, and PE/Cup interface testing. These demonstrate that the new sizes of the device perform equivalently to the predicate device in terms of physical integrity.
• Biocompatibility testing: Bacterial Endotoxin testing. This ensures the device meets pyrogen limit specifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML-enabled medical device meets its acceptance criteria based on the provided text, as the document is about a mechanical orthopedic implant, not an AI/ML device.

To answer your request, I would need a document detailing the evaluation of an AI/ML-enabled medical device.

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