(86 days)
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.