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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. This device was cleared in K022377. 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 profile options as the B/F allpolyethylene glenoid.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Trabecular Metal Glenoid:

This document is a 510(k) Summary for a medical device called the Trabecular Metal Glenoid. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence for regulatory clearance.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• The document states "Component stability testing was performed per ASTM F 2080-00 for the subject and predicate devices and cementing techniques."
• Sample Size: The exact number of samples (e.g., individual glenoid components tested) is not explicitly stated. However, it implies multiple samples were tested to generate "displacement data."
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It describes laboratory testing of the device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not applicable. This study is a mechanical performance test (component stability testing) against an ASTM standard, not a clinical study involving human assessment of ground truth. Therefore, there were no "experts" establishing ground truth in the traditional sense of a clinical trial. The "ground truth" here is the performance against the defined parameters of the ASTM F 2080-00 standard.

4. Adjudication Method for the Test Set:

• None. As this is a mechanical performance test, there is no need for an adjudication method for a test set in the way one would adjudicate clinical data. The results are based on objective measurements of displacement during cyclic loading.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No. This document describes a mechanical performance study, not a clinical MRMC study. There is no assessment of human reader performance, with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Yes, in spirit. The performance described is for the device itself ("algorithm only" in the context of mechanical testing), not involving human interaction as part of the primary performance evaluation. The "displacement data" is a direct measurement of the device's physical properties under specific loading conditions.

7. The Type of Ground Truth Used:

• The ground truth is based on mechanical performance specifications/standards, specifically ASTM F 2080-00 for component stability. The "ground truth" is that the device should demonstrate similar or equivalent stability performance to the predicate device under the defined testing parameters.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set" of data. The "training" for such a device is its design, manufacturing processes, and adherence to established engineering principles.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As above, there is no "training set" for a physical device in the context described in the prompt. The "ground truth" for the device's design and manufacturing is established through engineering specifications, material science, and adherence to quality control standards.

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