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The MJS Posterior Stabilized Knee System is indicated for use in total knee replacement procedures for patients suffering from:

• 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. .

The Posterior stabilized system is intended for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact and extra joint stability is required.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the MJS Posterior Stabilized Knee System. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the acceptance of an AI/ML-enabled medical device.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates the approval is based on substantial equivalence to existing devices, not on a new study demonstrating performance against specific acceptance criteria in the context of an AI/ML system.

Therefore, I cannot extract the requested information from the provided text for the following reasons:

• The device is a knee implant system, not an AI/ML-enabled medical device. The questions you've asked are specific to the evaluation and acceptance of AI/ML systems (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance).
• The document is an FDA 510(k) clearance letter. This type of document confirms substantial equivalence to a predicate device, which is a regulatory pathway that typically does not involve the detailed performance studies or AI-specific evaluation methodologies implicit in your questions.
• No performance data, acceptance criteria, or study details are present. The letter confirms the device can be legally marketed but does not provide any technical specifications, study methodologies, or results that align with your request.

To answer your questions accurately, I would need a document detailing the clinical or technical performance study of an AI/ML-enabled medical device, including its acceptance criteria and results.

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