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The Zimmer Trabecular Metal Reverse Shoulder System is indicated for the following:

Reverse application:

• 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.

Hemiarthroplasty/Total application:

• 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 where arthrodesis or resectional arthroplasty is not acceptable.

The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications).

The Trabecular Metal humeral and reverse base plate components are intended for either cemented or uncemented use. The reverse base plate requires two screws for initial fixation.

The Zimmer Trabecular Metal™ Reverse Shoulder System is a modular total shoulder prosthesis that was designed specifically to include patients with non-functional rotator cuffs. It was developed to either encompass a traditional shoulder prostheses, a reverse design or be transformed into a hemi-prosthesis depending on clinical cases encountered during the surgical procedure.

The provided text is a 510(k) summary for a medical device called the "Zimmer Trabecular Metal™ Reverse Shoulder System," submitted to the FDA. It does not contain information about acceptance criteria or a study that proves the device meets those criteria.

Instead, this document is a premarket notification for a new device, demonstrating its substantial equivalence to previously cleared predicate devices. The information provided focuses on the device's description, intended use, comparison to predicates, and regulatory classification.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth establishment, as this information is not present in the provided text.

The "Performance Data (Nonclinical and/or Clinical):" section explicitly states: "Non-clinical testing demonstrated that the Zimmer Trabecular Metal Reverse Shoulder System is as safe and effective as the predicate devices." This general statement does not provide specific acceptance criteria or detailed study results. The FDA's clearance (K052906) indicates that they found it "substantially equivalent" based on this information and comparison to predicates, not necessarily on a detailed study against pre-defined performance acceptance criteria unique to this device that would be included in this summary.

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