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The VerSys Beaded MidCoat Low Head Center 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 MidCoat Low Head Center Hip Prosthesis is a straight, modular femoral stem manufactured from Co-Cr-Mo alloy and has a sintered Co-Cr-Mo alloy bead porous surface coating. The prosthesis features a 12/14 Morse-type proximal neck taper to mate with the corresponding 12/14 bore of a femoral head component. Proximal body geometry of the prosthesis is trapezoidal.

This document is a 510(k) summary for the Zimmer VerSys R Beaded MidCoat Low Head Center Hip Prosthesis, which aims to demonstrate substantial equivalence to a predicate device. As such, it does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, expert ground truth, or comparative effectiveness with AI.

Instead, the document states that "Non-clinical performance testing demonstrated that the device is equivalent to the predicate." It focuses on showing that the new device's modifications do not change its intended use or fundamental scientific technology compared to the predicate device, the VerSys Hip System Beaded Hip Prosthesis (K973714).

Therefore, I cannot provide the requested information in the format specified because the provided text does not describe a study with acceptance criteria and a reported device performance in the way typically seen for AI/software devices. The submission is for a physical medical implant (hip prosthesis), and the "performance testing" referenced is likely mechanical and material testing to ensure equivalence, not a study involving human readers or AI.

Here's an attempt to address the points based on the available information, noting that many will be "Not Applicable" or "Not Provided" due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not provided. The testing mentioned is "non-clinical performance testing," which would typically involve physical samples of the prosthesis rather than a data test set.
• Data Provenance: Not applicable, as this refers to physical device testing, not a dataset.

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

• Not applicable. Ground truth as typically defined for AI/software (expert labels on data) is not relevant for this type of device submission. The "ground truth" would be the established performance characteristics of the predicate device, determined through engineering and mechanical testing standards.

4. Adjudication method for the test set

• Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, this type of study is not relevant for a physical hip prosthesis.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

• Not explicitly stated, but for physical device equivalence, the ground truth would typically be established engineering specifications, mechanical test results (e.g., fatigue strength, wear resistance), and material property standards, all benchmarked against the predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable.

In summary, the provided document is a 510(k) premarket notification for a physical medical device. It focuses on demonstrating "substantial equivalence" to a previously cleared predicate device through non-clinical performance testing, rather than presenting a performance study with detailed acceptance criteria and expert-labeled ground truth as would be expected for a software or AI medical device.

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