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The Portland Ceramic (Biolox-Forte) Femoral Head has the following indications for use:

• The patient should be skeletally mature.

· The patient's condition should be due to one or more of the following:

1. Osteoarthritis.

2. Rheumatoid arthritis.

3. Tumor conditions involving the upper third of the femur or of the Acetabular.

4. Ankylosing spondylitis.

5. Psoriatic arthritis.

6. Old osteomyelitis - with a long infection-free period and a normal WBC, ESR and Creactive protein.

7. Non union of femoral neck fracture or avascular necrosis of the femoral head.

8. Post-traumatic fracture/dislocation of the hip.

9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.

10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.

11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

The Portland Portland Ceramic (Biolox-Forte) Femoral Head is provided as a single component. The device is manufactured from an Alumina Oxide (Biolox-Forte) and is available in various sizes. The internal bore of the femoral head is designed to taper look (12/14) with the external male taper on a femoral hip stem providing articulation with a suitable acetabular module.

The provided document pertains to a 510(k) premarket notification for the Portland Ceramic (Biolox-Forte) Femoral Head, a ceramic femoral head prosthesis. It describes the device, its indications for use, and a summary of testing performed to demonstrate substantial equivalence to predicate devices.

However, the document does not contain information typically associated with acceptance criteria and studies for AI/ML-driven medical devices.
Instead, it details the regulatory submission for a physical medical implant. Therefore, the questions about AI/ML device performance, ground truth, expert adjudication, and training/test set sizes are not applicable to this document.

The "SUMMARY of TESTING" section states that "Portland Orthopaedics, Ltd. has provided analytical and mechanical testing to demonstrate the substantial equivalence of and compliance to standards for the Ceramic (Biolox-Forte) Femoral Head." This suggests that the acceptance criteria for this medical device relate to its material properties, mechanical performance, and compliance with established standards for ceramic femoral heads, rather than diagnostic accuracy or algorithmic performance.

Without further information on the specific analytical and mechanical testing conducted, it is not possible to provide a table of acceptance criteria and reported device performance in the format requested for AI/ML devices.

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