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The Corin Adaptor Sleeve is indicated for use with a Corin Unipolar Modular Head and a Howmedica Osteonics femoral hip stem with a V40™ trunnion in partial hip replacement procedures for patients suffering from pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.

The Corin Adapter Sleeve is a tapered sleeve component with a female V40™ taper to provide locking with a Howmedica Osteonics' femoral stem with a V40™ taper. In addition, the sleeve has a tapered male exterior surface that provides locking with a Corin Unipolar Modular Head. The Corin Adapter Sleeve is fabricated from Ti-6AI-4V alloy per ASTM F-136.

The provided document is a 510(k) summary for the Corin Adaptor Sleeve. It states that the device is substantially equivalent to legally marketed predicate devices in regards to intended use, design, materials, and operational principles. This type of submission (510k) usually relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with detailed acceptance criteria and performance data.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets specific performance criteria in the way typically seen for a new device requiring efficacy studies. The information requested regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this type of regulatory submission.

The document primarily focuses on:

• Device Description: The Corin Adaptor Sleeve is a tapered component designed to connect a Corin Unipolar Modular Head to a Howmedica Osteonics femoral hip stem with a V40™ taper. It is made from Ti-6AI-4V alloy.
• Indications for Use: For partial hip replacement in patients with certain conditions (osteoarthritis, rheumatoid arthritis, avascular necrosis, femoral neck fracture) where the femoral head is affected, the acetabular cavity is normal, and acetabular replacement is not needed or desired.
• Substantial Equivalence: The device is considered substantially equivalent to existing predicate devices like the V40™/C-Taper Adaptor Sleeve and the Unitrax Unipolar System.

In summary, the 510(k) process for this device relies on demonstrating equivalence to predicate devices, not on presenting new performance studies against specific acceptance criteria.

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