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The Arthrex Shoulder Humeral Fracture Prosthesis is indicated for severe pain or significant disability resulting from degenerative, rheumatoid, or traumatic disease or injury of the glenohumeral joint. This includes traumatic or pathological conditions of the shoulder resulting in fracture of the glenohumeral joint, including impression fractures, comminuted fracture, humeral head fracture, displaced 3-or4-fraqment proximal head fractures, avascular necrosis of the humeral head, and fractures of the anatomical neck. The Arthrex Shoulder Humeral Fracture Prosthesis is designed for cemented or non-cemented use. This device may be used for hemi or total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.

The device consists of: a stem body with a height adjustment mechanism in the neck section, composed of titanium (Ti6Al4V); a metal head support also of titanium; the prosthesis head composed of Cr-CO alloy. This device may be used for total shoulder repair, utilizing the appropriate Arthrex Univers Glenoid component, which is to be cemented in place.

This device is a shoulder prosthesis, and the provided text is a 510(k) summary and an FDA clearance letter. These documents describe the device, its intended use, and its substantial equivalence to predicate devices, but they do not contain any information about acceptance criteria or a study proving that the device meets specific performance metrics.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The provided text only touches upon:

• Intended Use: Severe pain or significant disability from degenerative, rheumatoid, or traumatic disease/injury of the glenohumeral joint, including various types of fractures and avascular necrosis. It can be used for hemi- or total shoulder repair.
• Substantial Equivalence: The primary basis for clearance is that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness.

In summary, the provided information does not include the details necessary to answer your request about acceptance criteria and a study proving their fulfillment.

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