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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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The Versa-Dial™ Humeral Head Prosthesis Is intended for:

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. Corrector of the proximal humerus where other methods of treatment are deemed Inadequate.
   indequate: 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 blological fixation applications. (Metal backed glenoid components offer optional screw fixation.)

Polyethylene glenold 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, and the glenold components of the Blo-Modular® Shoulder System.

The device is a single-use implant.

The Versa-Dial™ Humeral Head Prosthesis consists of a series of varioussized modular humeral heads with variable offset between 0.5mm and 4.5 mm. Each modular head consists of a 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 Blomet's Comprehensive® Shoulder System or Biomet's BioModular® Shoulder System depending upon which taper is used (i.e., in order to use with the Comprehensive® shoulder stem, the Comprehensive® Taper Adaptor must be used).

The provided document describes a 510(k) Premarket Notification for the Versa-Dial™ Humeral Head Prosthesis. This type of submission to the FDA focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Here's a breakdown of why and what information is present:

Missing Information (and why):

• 1. A table of acceptance criteria and the reported device performance: Not present. 510(k) submissions typically do not involve pre-defined performance acceptance criteria for clinical outcomes in the same way a PMA (Premarket Approval) would. The focus is on demonstrating that the new device is as safe and effective as a predicate device.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set data from the manufacturer is provided.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set data or expert-reviewed ground truth is mentioned.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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: Not applicable. This is a medical device (prosthesis), not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable (no clinical training data presented).
• 9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "proving" the device (in the context of a 510(k)):

The proof provided in this 510(k) document is centered around demonstrating substantial equivalence to predicate devices. This is achieved by:

• Device Description and Comparison to Predicates: The document details the Versa-Dial™ Humeral Head Prosthesis and explicitly states, "The technological characteristics (material, design, sizing, indications) of the Versa-Dial™ Humeral Head Prosthesis are similar or identical to the predicate devices." It also notes a redesign of the taper adaptor material (TT-6Al-4V vs. Co-Cr-Mo) and changed indicia, implying these changes do not alter substantial equivalence.
• Non-Clinical Testing: The document states: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This non-clinical testing (likely mechanical, material, and performance bench testing) is the primary "study" mentioned to support the device's functionality. No specific metrics or acceptance criteria for this non-clinical testing are provided in this summary, but the FDA's acceptance of the 510(k) implies these tests met regulatory expectations for substantial equivalence.
• Clinical Testing: The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This is very common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data and comparison to predicates.

In summary, for a 510(k) submission like this, the "acceptance criteria" are implicitly met by demonstrating that the device is substantially equivalent to legally marketed predicate devices, primarily through engineering analysis, material comparison, and non-clinical bench testing, and without the need for de novo clinical trials or pre-defined performance metrics against a clinical ground truth.

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