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When used with the AGC and Maxim Knee systems, the indications for use of the Cement-On Femoral Stem include: 1) painful and disabled knee joint resulting from osteoarthrits, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved, 2) failure of a previous joint replacement procedure, 3) correction of varus, valgus, or post traumatic deformity and 4) correction of unsuccessful osteotomy or arthrodesis.

This device is for use with bone cement.

The Cement-On Femoral Stem enhances fixation of prothesis to bone while still being able to maintain the posterior cruciate ligament. The stem is indicated when the soft tissues of the knee are intact but significant bony loss or fracture warrents the use of an intramedullary stem.

The Cement-On Femoral Stem is a Co-Cr &mm distal augment with an attached 120mm long intramedullary stem. The stem is angled at 7 · valgus and is fixed to the surface of the primary femoral component with bone cement.

The device is to be used with the appropriate AGC and Maxim knee components and is available in six different sizes.

The provided text is a "Summary of Safety and Effectiveness" for a medical device (Cement-On Femoral Stem). It describes the device, its intended use, potential risks, and claims substantial equivalence to other devices on the market. However, this document does not contain the specific information required to describe acceptance criteria and a study proving those criteria are met.

Here's why and what's missing:

• Acceptance Criteria: The document mentions "potential risks" but does not define specific, quantifiable acceptance criteria (e.g., minimum tensile strength, maximum wear rate, specific clinical success rates, etc.) that the device must meet.
• Study Details: While it implies equivalence to other devices, it doesn't describe a specific study that evaluated the performance of this particular device against defined acceptance criteria. There's no mention of sample size, data provenance, ground truth establishment, expert involvement, or statistical results.

Therefore, I cannot populate the requested table and answer the questions based only on the provided input.

To answer your request, I would need a different document, such as a clinical study report, a design verification and validation report, or a regulatory submission that includes performance data and acceptance criteria.

If such a document were provided, I would look for sections detailing:

• Performance Specifications/Acceptance Criteria: Often found in design control documents or regulatory submissions.
• Clinical Study or Bench Test Results: Specifically, data that directly addresses the performance metrics.
• Study Design: Information on sample size, patient population (for clinical studies), data collection methods.
• Ground Truth: How outcomes were determined (e.g., based on expert consensus, pathology, long-term follow-up).
• Reader Studies: If applicable, details on MRMC studies.

Without this information, any attempt to fulfill your request would be speculative and not based on the provided text.

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