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The Hemisphere™ Cemented Cup is intended for single use with bone cement in primary or revision arthroplasty surgery. Indications include:

• Osteoarthritis, rheumatoid arthritis, or other osteoarthroses of the hip joint;
• Certain femoral neck fractures;
• Idiopathic avascular (osteo) necrosis;
• Post-traumatic arthritis;
• Benign or malignant bone tumors where sufficient bone is present to seat the prosthesis;
• Previously failed implant

The Hemisphere™ Cemented Cup is intended for use with the Primaloc™ Cemented Hip (K962448) and Headloc™ CoCr femoral heads (K953977), both manufactured by Ortho Development Corporation, and other commercially available hip prosthesis, which have also received FDA clearance.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called the Hemisphere™ Cemented Cup. It primarily details the regulatory clearance for the device and its intended uses.

The document does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, or ground truth establishment relevant to the performance evaluation of an AI/ML medical device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided input. This document is a regulatory approval, not a technical performance study report.

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The Headloc™ Ceramic Femoral Head for the Primaloc™ Cemented Hip System is intended for single-use cemented implantation during primaryrevision surgery. The ceramic head allows for primary articulation between the acetabular cup and femoral stem to restore patient mobility. Indications for use are:

• Osteoarthritis, rheumatoid arthritis, or other osteoarthroses;
• Certain femoral neck fractures or dislocations;
• Post-traumatic arthritis;
• Idiopathic avascular necrosis of the femoral head;
• Benign or malignant bone tumors where sufficient bone stock exists to seat the prosthesis;
• Previous failed surgery;
• Total hip replacement where the surgeon indicates a ceramic head

The Headloc™ Ceramic Head may be used with the Primaloc™ Cemeted Hip System which is cleared for use under Premarket Notification K962448.

Headloc™ Zirconia Ceramic Heads

I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance results, study details (sample sizes, provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or ground truth establishment relevant to an AI/ML device.

The document is a 1997 FDA 510(k) clearance letter for a medical device called "Headloc™ Zirconia Ceramic Heads" and outlines its intended use and regulatory classification. It does not describe any studies comparing its performance against specific acceptance criteria in the context of AI/ML or diagnostic accuracy.

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