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The Zimmer Trabecular Metal Reverse Shoulder System is indicated for the following:

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.

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.

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 Trabecular Metal humeral and reverse base plate components are intended for either cemented or uncemented use. The reverse base plate requires two screws for initial fixation.

The Zimmer Trabecular Metal™ Reverse Shoulder System is a modular total shoulder prosthesis that was designed specifically to include patients with non-functional rotator cuffs. It was developed to either encompass a traditional shoulder prostheses, a reverse design or be transformed into a hemi-prosthesis depending on clinical cases encountered during the surgical procedure.

The provided document describes the acceptance criteria and a non-clinical study for the Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a separate "test set" in the context of evaluating a medical imaging or AI device. Instead, it refers to non-clinical performance testing. No sample size for a test set (e.g., number of patients or images) is provided, as this is a medical device and not a diagnostic AI system with patient data.

The data provenance is non-clinical testing, meaning it likely involved bench testing, mechanical simulations, and material characterization rather than human subject data. The country of origin for the data is not explicitly stated beyond the submitter's location (Warsaw, IN, USA).

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

Not applicable. As this is a medical implant system and not an AI-driven diagnostic device evaluated with a test set requiring expert ground truth annotations, this information is not relevant to the described study. The "ground truth" for this type of device would be established by engineering and material science standards for safety and efficacy.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of "ground truth" establishment by experts or adjudication methods in the context of this non-clinical performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this submission (a shoulder implant device).

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

Not applicable. This is a physical medical device (shoulder implant), not a software algorithm. Therefore, "standalone performance" in the context of an algorithm without human-in-the-loop is not relevant. The "standalone performance" of this device would refer to its physical function and integrity, which was assessed through non-clinical testing.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance evaluation is established through engineering standards, material specifications, and biomechanical principles. This includes demonstrating mechanical strength, durability, and biocompatibility that are comparable to or better than the predicate device. The document explicitly states "Non-clinical testing demonstrated that the Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm are as safe and effective as the predicate devices." This implies that the 'ground truth' for establishing safety and effectiveness relied on established scientific and engineering methodologies for implantable devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable. As there is no training set for an AI model, this question is not relevant.

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