Search Results

The Portland Cobalt Chrome 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 C-reactive 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 Cobalt Chrome Femoral Head is provided as a single component. The device is manufactured from a cobalt chrome alloy and is available in various sizes. The internal bore of the femoral head is designed to taper lock (12/14) with the external male taper on a Portland Orthopaedics femoral hip stem providing articulation with a suitable acetabular module.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any specific acceptance criteria.

The document is a 510(k) summary for the Portland Cobalt Chrome Femoral Head, which is a regulatory submission to the FDA. It primarily focuses on demonstrating "substantial equivalence" to existing legally marketed devices.

Here's what the document does include:

• Description of the Device: Details on its material (cobalt chrome alloy), design (taper lock), and intended use (articulation with an acetabular module and femoral hip stem).
• Indications for Use: A list of conditions for which the device is intended to be used (e.g., osteoarthritis, rheumatoid arthritis, certain hip fractures or revisions).
• Substantial Equivalence Information: States that the device is substantially equivalent to cobalt chrome femoral heads from Biomet and Exacted due to similarities in design, intended use, material, and manufacturing.
• Summary of Testing: Mentions that "Portland Orthopaedics, Ltd. has provided analytical and mechanical testing to demonstrate the substantial equivalence of and compliance to standards for the Cobalt Chrome Femoral Head." However, it does not provide any details about the specific tests performed, the acceptance criteria for those tests, or the results.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or expert involvement as this information is not present in the provided text.

Ask a specific question about this device