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The InfinityTM Fixation System is intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption of a ligament using soft tissue grafts. Examples of such procedures include anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, and lateral ligament.

The CONMED Infinity™ Fixation System is a family of metal buttons and nonabsorbable Hi-Fi suture for suspensory fixation of tendon to bone used in ligament reconstruction procedures. The Infinity™ Fixation System is provided individually packaged, single-use, sterile. The anchor, suture, and disposable driver are EO Sterilized.

This is a 510(k) summary for a medical device called the "Infinity™ Fixation System," which is intended for soft tissue to bone fixation in ligament reconstruction procedures. The document does not describe acceptance criteria in the way you've outlined for an AI/ML device. Instead, it details performance testing for a traditional medical device (a mechanical fixation system).

Therefore, I cannot provide the specific information you requested in bullet points 1 through 9 because the provided text does not contain information related to AI/ML device acceptance criteria or studies involving AI/ML components.

The document focuses on demonstrating substantial equivalence to a predicate device ("ConMed Linvatec XO Button") for a mechanical device through:

• Device Description and Intended Use: Comparing the Infinity™ Fixation System to the predicate device.
• Technological Characteristics: Highlighting similarities in how the devices work (e.g., providing suspension fixation, pre-attached sutures).
• Performance Data: Listing various types of engineering and biological tests conducted (e.g., Ultimate Fixation Strength, Biocompatibility, Sterilization, Shelf-life) to show the device performs as intended and is safe and effective. These are standard tests for orthopedic fixation devices, not AI/ML performance metrics.

To reiterate, there is no mention of:

• A table of acceptance criteria and reported device performance for an AI/ML component.
• Sample sizes for test sets related to AI/ML, data provenance, or explicit ground truth establishment methods for an AI/ML model.
• Expert involvement for establishing AI/ML ground truth or adjudication methods.
• MRMC studies or standalone AI/ML performance.
• Training set details for an AI/ML model.

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