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Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united 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 for total shoulder arthroplasty. Humeral heads with heights greater than 27 mm may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional non-constrained arthroplasty is not acceptable. The Trabecular Metal Glenoid must be fully or partially cemented in place in the USA.

The device is a monoblock glenoid component comprised of a Trabecular Metal base with an articular surface comprised of direct compression molded polyethylene. The TM Glenoid is designed to interface & articulate with Zimmer B/F humeral components and is available in one thickness option of 5 mm, and the same outer geometry and dimensions as the B/F glenoids cleared in K022377 and K031449.

The provided 510(k) summary describes a medical device, the "Trabecular Metal Glenoid," but it does not contain information about acceptance criteria or a study proving the device meets said criteria.

This 510(k) clearance is for a change in manufacturing technique to increase the interfacial area between UHMWPE and the Trabecular Metal glenoid base. The primary basis for substantial equivalence is that the device has the same external geometry, dimensions, articulation geometry, minimum polyethylene thickness, and size options as predicate devices.

The document states:

• "An engineering analysis showed that the increased area of polyethylene infiltration does not adversely affect device strength and increases the area of attachment between the UHMWPE and the Trabecular Metal glenoid base." This is the entire extent of the "performance data" mentioned.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what can be inferred or directly stated from the document, and what cannot:

Acceptance Criteria and Study Details for the Trabecular Metal Glenoid (Based on provided 510(k) Summary K043061)

1. Table of Acceptance Criteria and Reported Device Performance

Note: These are inferred "acceptance criteria" based on the described engineering analysis. The document does not explicitly list quantitative acceptance criteria values.

2. Sample size used for the test set and the data provenance

• Not provided. The document refers to an "engineering analysis," which typically involves bench testing, but no details on sample size, methodology, or data provenance (e.g., country of origin, retrospective/prospective) are mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Not provided. The "engineering analysis" likely refers to mechanical testing or simulation, not a clinical study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

• Not applicable / Not provided. This typically applies to clinical studies or image interpretation, which are not described here.

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, an MRMC study was not done. This device is a shoulder implant, not an AI-powered diagnostic tool.

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

• No, a standalone algorithm performance study was not done. This device does not involve an algorithm.

7. The type of ground truth used

• Not applicable. The "engineering analysis" likely relied on physical measurements, material properties, and mechanical stress/strain calculations, rather than a "ground truth" derived from clinical outcomes or expert consensus.

8. The sample size for the training set

• Not applicable / Not provided. This project involves a medical device (implant) and an engineering analysis, not a machine learning model that requires a training set.

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

• Not applicable. As above, no training set or machine learning model is involved.

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