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The DePuy Ceramic Femoral Head is indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and to reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

The DePuy Ceramic Femoral Head is composed of an alumina composite material and is available in a 36mm head diameter with a +12-offset option. The internal bore of the ceramic femoral head, which is designed to interlock with the external taper on the femoral hip stem, is available in a 12/14 Articul/eze taper option. The ceramic head is designed to mate with a corresponding DePuy femoral hip stem and provide the femoral articular surface of a total hip replacement.

The DePuy Ceramic Femoral Head is a ceramic femoral ball prosthesis, intended for use as the femoral head component in total hip arthroplasty procedures.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not describe a specific clinical test set or study for the DePuy Ceramic Femoral Head. Instead, the basis for substantial equivalence is primarily a comparison to a previously cleared predicate device (DePuy Ceramic Femoral Heads, K031803).

Therefore, there is no information on:

• Sample size used for a test set.
• Data provenance (e.g., country of origin, retrospective or prospective nature).

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

Since no specific test set or clinical study for this particular device is described as part of the 510(k) submission, there is no information regarding experts used to establish a "ground truth." The acceptance is based on substantial equivalence to a predicate device.

4. Adjudication Method for the Test Set

As there is no described test set or clinical study for the DePuy Ceramic Femoral Head in this submission, there is no information on an adjudication method.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided document. The submission relies on substantial equivalence to a predicate device, not on demonstrating improved human reader performance with AI assistance (which is not applicable here as this is a physical medical device, not an AI-based diagnostic tool).

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

This is a physical medical device (ceramic femoral head), not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not applicable and was not conducted or described.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance is the established safety and effectiveness of the legally marketed predicate device (K031803). The manufacturer asserts that the new device is substantially equivalent to this predicate based on core characteristics.

8. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning models. Since this is a physical medical device and its clearance is based on substantial equivalence to a predicate, there is no training set in the context of an algorithm.

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

As explained above, the concept of a "training set" with associated ground truth in the context of an algorithm is not applicable to this device's submission. The "ground truth" for acceptance is the predicate device's clearance.

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