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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Revision where other devices or treatments have failed
4. Correction of functional deformity
5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
6. Difficult clinical management problems, including cuff tear Difficult cinnoul mailing methods of treatment may not be suitable or may be inadequate.

The Versa-Dial™ Humeral Head Prosthesis is intended for use with the Comprehensive The Versa-Dial - Trainer either cemented or uncemented (press-fit) usc.

The Versa-Dial™ Humeral Head Prosthesis is intended for use with the glenoid The Velsa-Dai- Thumeral Includer System, either all polyethylene for cemented components of the "Ho-Modala" Biological fixation with optional screw fixation) use.

The Versa-Dial™ Humeral Head Prosthesis is a metallic humeral head designed to function as the articulating surface component of the Comprehensive Humeral Fracture System (K030710) and incorporates the glenoid components of the Bio-Modular® Shoulder System (K023063) that are either all polyethylene for cemented use or Bio-Modular® (biological fixation with optional screw fixation) use. The Versa-Dial™ Humeral Head Prosthesis are manufactured of Co-Cr-Mo alloy conforming to ASTM F 75.

This FDA 510(k) summary for the Versa-Dial Humeral Head Prosthesis indicates that clinical testing was NOT required for this device. Therefore, there is no study to prove the device meets acceptance criteria in the traditional sense of a clinical trial or performance study against specific criteria.

Instead, the device gained clearance based on demonstrated substantial equivalence to legally marketed predicate devices through non-clinical mechanical testing.

Here's the breakdown of the information requested, based on the provided document:

1. Table of acceptance criteria and the reported device performance

Since clinical testing was not performed, there are no specific performance acceptance criteria or reported device performance metrics in the way one would expect from a diagnostic or AI device study. The acceptance criterion for mechanical testing would generally be "meets or exceeds the mechanical properties of the predicate device" or "meets relevant ASTM standards for shoulder prostheses."

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

• Sample Size: Not applicable. Mechanical testing is typically performed on a limited number of manufactured units of the device and its predicate, not a "test set" of patients or data points. The document does not specify the number of prostheses tested for the mechanical evaluation.
• Data Provenance: Not applicable in the context of clinical data. The mechanical testing would have been conducted in a laboratory setting, likely by Biomet or a contract laboratory.

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

• Not applicable. There was no clinical ground truth established for a test set of human subjects.

4. Adjudication method for the test set

• Not applicable. There was no clinical test set 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. This device is a shoulder prosthesis, not an AI-assisted diagnostic tool.

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

• No. This device is a shoulder prosthesis, not solely an algorithm. The "standalone" performance of the device refers to its mechanical integrity, which was assessed through non-clinical testing.

7. The type of ground truth used

• The "ground truth" for this device's approval was based on demonstrating mechanical equivalence to previously approved, legally marketed predicate devices and compliance with relevant material standards (ASTM F 75). This is a regulatory "ground truth" rather than a clinical or pathological one.

8. The sample size for the training set

• Not applicable. There was no "training set" in the context of an AI/algorithm.

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

• Not applicable. There was no "training set."

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