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• 1. Non-inflammatory degenerative ioint 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 arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Humeral components with a MacroBond surface coating are indicated for either cemented or uncemented press-fit applications.

Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation).

Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.

The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular Shoulder Stems, the glenoid components of the Bio-Modular Shoulder System, and the glenoid components of the Comprehensive Shoulder System.

The Titanium Versa-Dial Humeral Head Prosthesis are indicated for patients with suspected cobalt allov sensitivity. The wear properties of Titanium and Titanium allovs are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Titanium Versa-Dial™ Humeral Head Prosthesis consists of a series of various-sized modular humeral heads with variable offset between 0.5mm and 4.5mm. The humeral heads consist of a shell head and a taper adaptor. The taper adaptor is impacted into the head in a certain position to achieve the desired amount of offset. The system can be used with Biomet's Comprehensive® Shoulder System or Biomet's BioModular® Shoulder System.

The document does not describe the acceptance criteria for a medical device in terms of performance metrics like accuracy, sensitivity, or specificity, nor does it detail a study proving the device meets such criteria. This document is a 510(k) premarket notification summary for the "Titanium Versa-Dial™ Humeral Head Prosthesis."

Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical testing and engineering evaluations, rather than a clinical performance study with acceptance criteria.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and reported device performance:

The document does not present a table like this because it's not a study reporting performance against specific clinical acceptance criteria. The acceptance refers to engineering criteria for mechanical performance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Test set sample size: Not specified. The testing mentioned is non-clinical (torsional separation, axial disassembly, engineering analysis of wear), not involving patient data. The "test set" would refer to physical device samples or theoretical models for these non-clinical evaluations.
• Data provenance: Not applicable in terms of patient data. The non-clinical testing would have been conducted by Biomet Manufacturing Corp. or their contracted labs.

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

• Not applicable. The ground truth for engineering tests is based on established engineering principles and measurement techniques, not expert consensus on clinical findings.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This concept is relevant for clinical studies where multiple human readers interpret data, typically in diagnostic imaging or pathology. For non-clinical engineering tests, the results are objectively measured.

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 is a medical device for orthopedic surgery (humeral head prosthesis), not an AI diagnostic or assistance tool. Therefore, MRMC studies involving human readers and AI are not relevant.

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

• No. This is a physical implantable device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical tests, the "ground truth" is based on:
  • Objective physical measurements: For torsional separation and axial disassembly strength.
  • Engineering analysis and scientific principles: For wear behavior comparison, likely relying on material science, biomechanics, and simulation or established wear models.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI-based device, so there is no training set in that context. The device design and materials are based on established engineering knowledge and previous predicate device designs.

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

• Not applicable for the reasons mentioned above.

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