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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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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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