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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.

Not Found

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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