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Indicated for use only with bone cement for patients suffering from: Severe knee joint pain, loss of mobility and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, Correction of functional deformities. Posttraumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, Varus or flexion trauma. Knee fractures untreatable by other methods.

The Genius / Genuin Total Knee System has 3 major components:

• Femoral component
• Tibial component - Includes Tibial Tray and Tibial Insert
• Patellar component

The provided text describes a 510(k) premarket notification for a medical device called the "Genius / Genuin Total Knee System." It does not contain information on acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML algorithm. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance (mechanical testing and material characterization).

Therefore, I cannot provide the requested information. The document explicitly states:

• Clinical Performance Data/Information: "Not provided as the device is proven to be substantially equivalent to predicate device."
• Acceptance Criteria for an AI device: Not present.
• Study proving device meets acceptance criteria: Not present.

The information provided pertains to the mechanical and material aspects of a knee implant, not an AI or algorithm-driven medical device.

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