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The KATOR Suture Anchor is intended for fixation of suture to bone in rotator cuff repairs and Achilles tendon repairs.

The KATOR Suture Anchor is a device which is preloaded with suture and is designed to attach soft tissues to bone.

This document, a 510(k) premarket notification from the FDA, pertains to a medical device (KATOR Suture Anchor) and does not describe or contain information about a study proving that a device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product.

Instead, this document is a Traditional 510(k) approval for a physical medical device (suture anchor). The "tests" mentioned are nonclinical (mechanical) tests to ensure the device's physical performance, not diagnostic performance of an AI algorithm.

Therefore, I cannot provide the requested information for an AI/SaMD product based on this document. The document lists:

• Device Name: KATOR Suture Anchor
• Regulation Name: Smooth or threaded metallic bone fixation fastener
• Regulatory Class: Class II (physical device)
• Product Code: MBI (physical device)
• Predicate Device: Arthrex Corkscrew FT (K061665) - also a physical device.

The "Nonclinical Testing" section states:
"The device performance was characterized through the following tests:

• Static and Dynamic Performance
• Suture Knot Strength"

These are mechanical tests, not performance studies for a diagnostic AI.

To answer your request about acceptance criteria and a study for an AI/SaMD, I would need a document that describes the clinical performance evaluation of an AI or software device, typically involving a test set, ground truth establishment, and statistical analysis of diagnostic metrics. This document does not contain that information.

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