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The B2C hip stem system is intended to be used as a press fit or cemented femoral hip component as part of a total hip arthoplasty. The stem geometry has been designed to be either implanted with or without cemented into the femoral cavity. The stems are to be used to restore the femoral side of a total joint arthoplasty and is used in conjunction with an acetabular cup. The indications for use of the B2C hip system are as follows: Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies. Salvage of previous unsuccessful procedures such as osteosynthesis, joint reconstruction, arthrodesis, hemi or total hip arthroplasty. Bipolar head or Austin Moore type head revision. Fracture or avascular necrosis of the femoral head in the elderly. Replacement of acetabular and stem component in total hip arthroplasty. Primary arthroplasty of the acetabular in dysplastic hips.

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I apologize, but the provided text (pages 0, 1, and 2) does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The text consists of an FDA 510(k) clearance letter for the "Lepine, B2C Hip System" and its statement of intended use.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is concerned with the regulatory clearance of a medical device (a hip stem system) based on substantial equivalence to a predicate device, rather than a detailed performance study with specific acceptance criteria as you've outlined.

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