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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. fn the USA. the Trabecular Metal Glenoid must be cemented under the base (see surgical technique for details) or fully cemented in place.

The Zimmer Trabecular Metal Reverse Shoulder System consists of conventional and reverse, semi- and non constrained shoulder prostheses for total or hemiarthroplasty applications.

The provided text is a 510(k) premarket notification document for a medical device, the Zimmer® Trabecular Metal™ Reverse Shoulder System. This document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a study designed to establish acceptance criteria or device performance in the manner of an AI/ML product.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, ground truth, and expert involvement for an AI medical device cannot be extracted from this document. This document primarily describes the device's indications for use, its classification, and a labeling modification based on non-clinical MRI compatibility testing.

However, based on the limited information related to "performance" in this document, I can provide the following, interpreting "acceptance criteria" and "device performance" in the context of the MRI compatibility evaluation mentioned:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified beyond "the components of the Zimmer Trabecular Metal Reverse Shoulder System". It implies testing of the physical components themselves.
• Data Provenance: Not specified, but the testing was conducted to meet US FDA guidance.
• Retrospective/Prospective: Neither. This was a non-clinical testing of physical implants.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth, in this context, would be the physical properties and behavior of the implants when subjected to MRI conditions, measured directly according to established test methods. No human experts were involved in "establishing ground truth" in the diagnostic sense. The "ground truth" for MRI compatibility is determined by established physical phenomena and measurement standards for magnetic fields, heating, and artifact generation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This was physical testing of implants against engineering standards, not a diagnostic assessment requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study was done. This document is not about an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This document is not about an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For theMRI compatibility, the "ground truth" was established by direct physical measurement and evaluation of the components' properties (e.g., magnetic susceptibility, induced heating, artifact generation) under specified MRI conditions, in accordance with the referenced FDA guidance.

8. The sample size for the training set

• Not applicable. This document is not about an AI/ML product, so there is no training set.

9. How the ground truth for the training set was established

• Not applicable. There is no training set.

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