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

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.

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.

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 humeral components are intended for either cemented use. The reverse base plate is intended for uncemented use, and requires two screws for fixation. When used in a total shoulder application, the all-polyethylene glenoid components are intended for cemented use only. In the USA, the Trabecular Metal Glenoid must be cemented under the base (see surgical technique for details) or fully cemented in place.

The proposed Base Plates and Humeral Stems are a line extension of the Zimmer Trabecular Metal Reverse Shoulder System, which consists of conventional and reverse, semi- and non-constrained shoulder prostheses for total or hemiarthroplasty applications.

I am sorry, but based on the provided text, there is no information about acceptance criteria, reported device performance, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment.

The document is a 510(k) premarket notification for the Zimmer Trabecular Metal Shoulder System, primarily focusing on its substantial equivalence to previously cleared predicate devices. It lists the device's indications for use, its classification, and mentions that non-clinical performance testing was conducted according to FDA guidance. However, it explicitly states:

"Clinical data and conclusions were not needed for this device."

This indicates that a study with the detailed performance criteria and methodologies you requested was not a requirement for the clearance of this specific device based on the information provided in this document.

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