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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 Non-Porous 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 hemi-arthroplasty applications. The proposed devices differ from the predicate humeral stems in that the proposed devices do not have Trabecular Metal in the proximal region of the stem.

This document is an FDA 510(k) clearance letter for a medical device (Zimmer Trabecular Metal™ Reverse Shoulder System, Non-Porous Humeral Stems). It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria in the context of an AI/ML medical device.

The provided text focuses on the regulatory clearance process for a shoulder implant, including:

• Substantial equivalence determination to predicate devices.
• Indications for Use.
• Device description and comparison to predicates.
• Mention of non-clinical performance data (fatigue testing, stability testing) but no details on acceptance criteria or results.
• A clear statement that "Clinical data and conclusions were not needed for this device." This explicitly means no clinical study, as understood for AI/ML device performance evaluation, was performed or required for this 510(k) submission.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies because the document pertains to a physical orthopedic implant and its FDA clearance, not an AI/ML medical device or its performance evaluation against defined criteria in a clinical or validation study setting.

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