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The V40 Zirconia Femoral Heads are intended to be used with modular femoral components in primary and secondary cementless total hip replacement procedures. These devices are intended to articulate with a polyethylene cup or a metal backed polyethylene cup component to reconstruct painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis, subcapital fracture, or a revision of a failed femoral prosthesis.

This device is a modular femoral head component which is affixed to a femoral stem component and articulates with a polvethylene acetabular cup or a metal backed polvethylene acetabular cup to reconstruct painful and/or severely disabled ioints resulting from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, avascular necrosis, subcapital fracture or a revision of a failed femoral prosthesis. The Zirconia Femoral Heads described in this submission are a modification of a previously cleared Zirconia head (K952418). The modification is a change in the supplier of the device and the introduction of additional sizes.

The provided text describes a 510(k) premarket notification for "V40 Zirconia Femoral Heads," which are components of a hip replacement system. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study proving performance against acceptance criteria in the way a clinical trial for a novel drug or a complex AI diagnostic device would.

Here's an analysis based on the given text, filling in what information is available and noting what is not:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The V40 Zirconia Femoral Heads are a Class II medical device, specifically a component of a hip joint prosthesis. The submission seeks to demonstrate substantial equivalence to previously cleared devices (Howmedica® V40 Zirconia Femoral Head (K952418) and Howmedica® 32mm Zirconia Femoral Head (2° 52') (K920577)). The "study" mentioned here refers to testing conducted to ensure the physical properties of the new device meet established safety and performance benchmarks, rather than a clinical study involving patients.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that testing included ultimate compression strength and axial distraction. The specific quantitative acceptance criterion is only provided for ultimate compression strength, derived from an FDA Guidance Document. For axial distraction, the criteria are not explicitly stated, but the clearance implies satisfactory performance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size for the mechanical tests (ultimate compression strength and axial distraction). It only states "All heads tested for ultimate compression strength" failed at loads higher than 46 kN, implying a representative sample was tested.

• Sample Size for Test Set: Not explicitly stated (implied to be a representative sample of V40 Zirconia Femoral Heads).
• Data Provenance: The testing was conducted by Howmedica Inc. for their proprietary product, likely in a laboratory setting. The country of origin for the data is implicitly the USA, where the company is based and seeking FDA clearance. The data is prospective in the sense that it was generated specifically for this 510(k) submission to demonstrate compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and submission. The "ground truth" for mechanical testing like compression strength or axial distraction is determined by physical measurement against engineering specifications and regulatory guidance, not by expert consensus or interpretation as would be the case for an AI diagnostic device.

4. Adjudication Method for the Test Set

This information is not applicable. Mechanical testing results are objective measurements rather than subjective interpretations requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

This is not applicable as this is a physical medical device (femoral head) and the submission is not for an AI-assisted diagnostic or treatment system. Therefore, there is no human-in-the-loop performance improvement to measure.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable. This device is a physical component, not an algorithm. Its performance is inherent in its material properties and design, demonstrated through mechanical testing.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Engineering Specifications: Designed to meet certain mechanical properties.
• Regulatory Guidance Documents: Specifically, the "FDA Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems," which provided the 46 kN threshold for ultimate compression strength.

8. Sample Size for the Training Set

This is not applicable. This is a physical device, not a machine learning algorithm, so there is no training set in the context of AI.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as #8.

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