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The ODC™ B2 Bipolar Cup for the Primaloc™ Hip System is intended for single-use cementless implantation during primary or revision arthroplasty surgery. The bipolar cup allows for primary articulation between the acetabulum and femoral stem to restore patient mobility. Indications for use are:

• . Osteoarthritis, theumatoid arthritis, or other osteoarthrosis of the hip joint;
• 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:
• Previously failed surgery ●

The ODC™ B2 Bipolar Cup may be used with the Primaloc™ Cementless Hip System, which is cleared for use under Premarket Notification K953977.

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The provided document is a 510(k) clearance letter from the FDA for the ODC™ B2 Bipolar Cup. This type of document declares that a medical device is substantially equivalent to a predicate device already on the market. It does not contain information about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval based on equivalence, not on detailed performance study data.

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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.

Not Found

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™ Cementless Hip System is intended for single-use cementless implantation during primary revision 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

Not Found

This document is a 510(k) clearance letter from the FDA for the Headloc™ Alumina and Zirconia Ceramic Heads, dated July 9, 1997. It is a clearance for a medical device and not a study proving device performance or detailing acceptance criteria and performance against those criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted from the provided text.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices, not a scientific report on its performance.

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