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The DePuy Delta 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 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 intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head.

The DePuy Delta Ceramic Femoral Head is composed of an alumina composite material and is available in a 36mm head diameter with +9 and +12 offset options. The internal bore of the ceramic femoral head taper is available in an 11/13 S-ROM option. The Delta Ceramic head is designed to mate with DePuy femoral hip stems with a corresponding taper design. The ceramic femoral head mechanically locks with the femoral hip stem via a taper junction, and articulates with a polyethylene acetabular component.

This is a traditional medical device, not an AI/ML device. Therefore, the concepts of "acceptance criteria," "test set," "training set," "ground truth," and "AI assistance" are not applicable in the context of this device.

The DePuy Delta Ceramic Femoral Head is a physical orthopedic implant. Its approval is based on demonstrating substantial equivalence to previously cleared predicate devices (K031803 and K040644), meaning it has the same intended use, indications, design, manufacturing methods, sterilization, and packaging. The document provided outlines the device's description, indications for use, and the basis of this substantial equivalence.

There is no study described that "proves the device meets acceptance criteria" in terms of performance metrics like sensitivity, specificity, AUC, or reader improvement with AI assistance, because these are not relevant for this type of device. Performance for this class of device is typically assessed through mechanical testing, biocompatibility studies, and clinical experience with the predicate devices, rather than algorithmic performance evaluation.

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