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Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; non-union humeral head fracture; displaced 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult management problems where arthrodesis or resectional arthroplasty are not acceptable. The AEQUALIS Shoulder System is intended for cemented use only.

The AEQUALIS Shoulder System is intended to treat conditions such as extensive soft tissue damage to the gleno-humeral joint, osteoarthritis, rheumatoid otheritis, traumatic arthritis, and osteonecrosis following severe trauma to the joint. The usual goal of such surgery is to restore the shoulder joint to its best working condition and to reduce or eliminate pain. The SEQUALIS Shoulder System is intended to accomplish these goals. With the AEQUALIS Shoulder System the natural glenoid elements of the shoulder may be conserved or replaced as warranted by the state of disease of injury. Through the AEQUALIS Shoulder System is primarily intended for use as a cemented total shoulder replacement system, it is equally useful as a hemi-shoulder. The modular nature of this system allows for the later conversion of a primary hemi-arthroplasty to a total shoulder replacement. The present Device Modification submission corresponds to the addition of 3 long humeral stems to 3 Inc pressite 2010 stem/neck angle, with the same indications for use already covered by the previous 510(k) clearance.

This is an orthopedic device submission, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study design for AI/ML performance is not applicable and cannot be extracted from the provided text.

The document describes the AEQUALIS Shoulder System, a total-shoulder and hemi-shoulder system, and a modification adding three long humeral stems. The submission is a Special 510(k) for device modification, indicating a comparison to a legally marketed predicate device (AEQUALIS Shoulder system, K952928, and Select Shoulder CoCr Humeral stem, K962315) to establish substantial equivalence.

The "study that proves the device meets the acceptance criteria" in this context refers to demonstrating substantial equivalence to a predicate device, typically through documentation of design specifications, materials, manufacturing processes, and sometimes bench testing or biocompatibility testing, rather than performance metrics of an AI algorithm.

Therefore, the table for acceptance criteria and device performance, and all subsequent points related to AI/ML study design, cannot be created or answered from this document.

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