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The Univers Revers CA humeral head and adapters are indicated for:
• salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed
humeral stem, to an anatomic hemi-shoulder replacement; or
• conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator
cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement
when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has
been implanted.
The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and
a functional deltoid muscle is necessary to use the device.

The subject device is a line extension to the Arthrex Univers Revers CA Heads and Adapters cleared in
K151527. The subject device components are smaller and are made of the same materials (cobalt
chromium, titanium, and UHMWPE) as the predicate. The subject devices are designed for use with the
Arthrex implantable devices cleared in K221232, K230366, K161782, K142863 and K170414. The
subject devices are labeled with MRI conditional claims in accordance with Arthrex labeling cleared
under K230513.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study as the provided text does not contain information about an AI/ML device or software. The document is an FDA 510(k) clearance letter for a medical device called "Univers Revers CA Head and Adapter," which is a shoulder prosthesis. The performance data section refers to mechanical and biocompatibility testing, not AI/ML algorithm performance.

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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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