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Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, theumatic 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 nonconstrained arthroplasty is not acceptable. In the USA, the device must be cemented under the base (see surgical technique for details) or fully cemented in place.

The device is a monoblock glenoid component comprised of a Trabecular Metal base with an articular surface composed of direct compression molded polyethylene (UHMWPE). 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 articular geometry and dimensions as the B/F Glenoid implants cleared in K022377 and K031449.

This document is a 510(k) premarket notification for a medical device, the Zimmer Trabecular Metal Glenoid. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain acceptance criteria for device performance or a study that proves the device meets such criteria.

Instead, this is a regulatory submission focused on demonstrating that the new device's technological characteristics, materials, and intended use are similar enough to previously cleared devices that it can be marketed without undergoing a new premarket approval process. The information provided is primarily for regulatory clearance rather than a performance study report.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance: This document does not establish performance acceptance criteria or report device performance against them.
2. Sample size used for the test set and the data provenance: There is no mention of a clinical or ex-vivo test set used to demonstrate performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such test set is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document discusses "documentation" that was provided to demonstrate substantial equivalence, focusing on:

• Intended use/indications for use
• Materials (Trabecular Metal and UHMWPE, similar to numerous other cleared Zimmer devices)
• Technological characteristics (same external articulating geometry, dimensions, minimum polyethylene thickness, sizing options as predicate).
• Basic principles of operation.

It also highlights that modifications were made to:

• Increase interfacial area for attachment between Trabecular Metal and UHMWPE.
• Increase interfacial area between UHMWPE and bone cement mantle.
• Decrease likelihood of center pilot post damage during impaction/insertion.
• Increase overall fatigue and static strength of the Trabecular Metal base.

These points describe design improvements and comparisons to predicate devices, but they do not constitute a performance study with acceptance criteria and measured outcomes. For a 510(k) submission like this, the "study" is often a comparison of technical specifications, materials, and intended use to a legally marketed predicate device, rather than a clinical trial demonstrating specific performance metrics against an acceptance threshold.

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