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The RI.KNEE Adjustable Tibia Cut Guide is intended to be used in conjunction with the CORI surgical system during total knee arthroplasty.

The subject RI.KNEE Adjustable Tibia Cut Guide is a set of surgical instrument components used during total knee arthroplasty (TKA) to make the resections to the tibia by guiding a surgical saw through the saw slot. The cut guide is used with the Smith and Nephew (Blue Belt Technologies) CORI surgical system. The subject Tibia Cut Guide offers an alternative to the tibia cut guides currently available in the CORI system and provides direct attachment of the tibia tracker to reduce surgical steps for tibia tracker fixation.

The provided text does not contain any information about an AI/ML device or its performance. The document is a 510(k) premarket notification for a physical medical device, the "RI.KNEE Adjustable Tibia Cut Guide," which is a surgical instrument.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, human reader performance, or ground truth establishment for an AI/ML device, as there is no such device described in the input.

The document discusses:

• The device's intended use: a surgical instrument used during total knee arthroplasty.
• Its classification: Class II, Stereotaxic Instrument.
• Performance data from non-clinical testing: Summative Usability Evaluation, Function and Robustness Testing, Biocompatibility, Cleaning, and Sterilization. These are standard tests for physical surgical instruments, not AI/ML algorithms.
• Substantial equivalence to a predicate device (Real Intelligence Cori).

There is no mention of any AI or machine learning components in the RI.KNEE Adjustable Tibia Cut Guide, nor any studies that would involve human-in-the-loop performance with an AI, MRMC studies, or ground truth establishment relevant to AI/ML model training or testing.

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