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The VerSys Beaded FullCoat Calcar Hip Prosthesis is designed to achieve biologic fixation to bone and is indicated for:

Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, disability due to previous fusion, previously failed endoprostheses and/or total hip components in the affected extremity, and acute femoral neck fractures.

Hemi-hip replacement for the following: fracture dislocation of the hip, elderly, debilitated patients when a total hip replacement is contraindicated, irreducible fractures in which adequate fixation cannot be obtained, certain high subcapital fractures and comminuted fractures, secondary avascular necrosis of the femoral head, pathological fractures of the femoral neck, and osteoarthritis in which the femoral head is primarily affected.

Like its predicate, the VerSys Beaded FullCoat Calcar Hip Prosthesis is a modular femoral stem manufactured from Co-Cr-Mo alloy and has a sintered Co-Cr-Mo alloy bead porous surface coating. The modified device features a calcar region designed with 10 and 20mm build-up heights in both straight and bowed hip stems.

The document provided describes a premarket notification (510(k)) for the VerSys® Beaded FullCoat Calcar Hip Prosthesis, not a study assessing the performance of Artificial Intelligence (AI) or a software product against acceptance criteria.

The information primarily focuses on establishing substantial equivalence to a predicate device, which is a regulatory pathway for medical devices in the United States. Therefore, most of the questions pertaining to acceptance criteria and a study proving a device's performance with specific metrics like sensitivity, specificity, or human improvement with AI assistance are not applicable to this document.

However, I can extract the relevant information regarding the device description, intended use, and the performance data that was provided for its clearance.

Acceptance Criteria and Study for VerSys® Beaded FullCoat Calcar Hip Prosthesis

Given that this is a 510(k) submission document for a physical medical device (hip prosthesis) and not an AI/software product, the concept of "acceptance criteria" and "device performance" as typically applied to AI studies (e.g., sensitivity, specificity, human-in-the-loop improvement) is not directly presented in the same format.

Instead, the "acceptance criteria" for a 510(k) submission are primarily related to demonstrating substantial equivalence to a legally marketed predicate device. This involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The "study" in this context is the comparison and analysis performed to support this substantial equivalence.

Summary of Relevant Information from the Document:

1. Table of Acceptance Criteria and Reported Device Performance:

• No explicit table of quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) or direct "reported device performance" metrics (like clinical trial outcomes comparing the new device to a standard) is provided in this 510(k) summary.
• The primary "acceptance criterion" for this submission is substantial equivalence to the predicate device.
• The "reported device performance" is a finite element analysis (FEA) demonstrating equivalence.

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

• Not applicable. This submission does not involve a "test set" or "data provenance" in the context of an AI/software study. The "testing" involved a finite element analysis, which is a computational simulation. The "data" would be the engineering specifications and material properties of the devices.

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

• Not applicable. As this is a mechanical device and a 510(k) submission, there is no "ground truth" established by experts in the context of diagnostic accuracy for a test set. Engineering and materials science expertise would be involved in the design and analysis.

4. Adjudication method for the test set:

• Not applicable. No test set or adjudication method is described in the context of an AI/software study.

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 physical hip prosthesis, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant to this submission.

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

• Not applicable. This is a physical hip prosthesis, not an algorithm.

7. The type of ground truth used:

• Not applicable in the AI context. For a physical device like this, the "ground truth" for design validation and safety would be established through industry standards, biocompatibility testing, mechanical testing (fatigue strength, wear, etc.), and clinical history of similar devices. The document specifically mentions Finite Element Analysis (FEA) as the performance data. FEA uses mathematical models and simulations to predict how a product reacts to forces, heat, fluid flow, and other physical effects. Its "ground truth" or validation would come from physical tests of prototypes or established engineering principles.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning model.

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

• Not applicable. There is no "training set" as this is not an AI/machine learning model.

In summary: The provided document is a regulatory submission (510(k)) for a revision hip prosthesis. The "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to a predicate device through engineering analysis (Finite Element Analysis) rather than clinical performance data or AI algorithm validation against specific metrics.

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