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The Balanced Knee® System Revision is intended for cemented use only in knee arthroplasty procedures whose indications include:

1. Loss of joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Moderate valgus, varus, or flexion deformities.
6. Revision procedures where other treatments or devices have failed
   The Balanced Knee® System Revision is indicated in the salvage of previously failed surgical attempts where femoral bone loss may require the use of augments or stem extensions.

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I am sorry, but based on the provided document, the information required to answer your request is not present. This document is a 510(k) clearance letter from the FDA for the "Balanced Knee System Revision" and details its indications for use. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

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