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Total knee components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are absent or incompetent and the collateral ligaments remain intact. Smith & Nephew, Inc. High Performance Knee components are indicated for use only with cement and are single use devices.

The High Performance Knee consists of femoral, tibial insert and patellar components to be used with existing Genesis II tibial trays. The High Performance Knee is a total knee system which provides the ability for greater flexion to those patients who have the anatomical capability to allow a greater flexion range.

The provided text describes a medical device, the "High Performance Knee," and its regulatory clearance (510(k)). However, it does not contain information about acceptance criteria for a study, a study that proves the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement in such a study.

The document is a summary of safety and effectiveness, along with the FDA's 510(k) clearance letter. It focuses on demonstrating "substantial equivalence" to predicate devices, rather than presenting a performance study with specific acceptance criteria and results.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided input. The document explicitly states:

"A review of the mechanical test data indicated that the High Performance Knee is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure."

This statement implies that mechanical testing was performed, but it does not provide the specific "acceptance criteria" for that testing, the detailed "reported device performance" against those criteria, or any of the other study details requested. The focus is on demonstrating equivalence, not on a new performance study with independent acceptance criteria.

Missing Information:
All requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert involvement, MRMC studies, or standalone performance is not present in the provided text.

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