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The Profix Plus Tibial Insert when used with the Profix Knee System is designed for patients with the following indications: 1) Rheumatoid arthritis 2) Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result. 3) Failed osteotomies, unicompartmental replacement, or total knee replacement. 4) Constrained Systems are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Profix Plus Tibial Insert is also indicated for use where a knee cannot be stabilized by soft tissue release. The Profix Plus Tibial Insert is part of a system that is indicated for use only with cement and is a single use device.

The Profix Plus Tibial insert is designed to work with the Profix Knee System to provide for the option of rotational constraint. The tibial insert is a single use device. The Profix Knee System is for Cemented use only.

The provided document, "EXHIBIT 4 Summary of Safety and Effectiveness" for the Smith & Nephew Orthopaedics Profix Plus Tibial Insert, does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

The document primarily focuses on:

• Product Description: "Profix Plus Tibial Insert" as a single-use device, part of the Profix Knee System.
• Indications for Use: Listing specific types of arthritis and situations where the device is indicated (e.g., failed osteotomies, constrained systems for ligament deficiencies).
• General Statement on Testing: A very high-level and unquantified statement: "This device has been tested and produced acceptable results that indicate that the product should perform well."

Therefore, I cannot provide the requested information in the table or answer the specific questions (sample size, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set details) because this data is not present in the input document.

The document is a summary of safety and effectiveness, but it lacks the scientific study details typically associated with proving acceptance criteria for medical devices. It seems to be a regulatory submission document that describes the device and its intended use, rather than a detailed report of performance studies.

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