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The JAWS Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis and fragment fixation of the bones and joints of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.

The JAWS Nitinol Staple System includes three styles of bone staples having various sizes to accommodate a variety of small bone applications. The implants and instruments are sold sterile.

The provided text describes a 510(k) premarket notification for the JAWS Nitinol Staple System, focusing on substantial equivalence to a predicate device and MRI safety and compatibility testing. It does not describe an AI/ML powered device, and therefore does not contain information on acceptance criteria for an AI model, a study proving an AI model meets acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Performance Testing" section states that "MR Safety and Compatibility Testing has been completed and presented in the submission as recommended in the FDA Guidance 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment' issued May 20, 2021, including FDA-recognized standards tests for the following potential hazards."

Therefore, I cannot fulfill your request for an AI/ML-specific acceptance criteria and study description based on the provided document. The document describes a physical medical device (bone staples) and its testing for safety and compatibility in an MRI environment.

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