(30 days)
The Betta Link™ Knotless Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.
Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.
The Betta Link™ Knotless Anchor System consists of an inserter and PEEK (Polyether-ether-ketone) non-absorbable anchor. The device is a manual surgical device and is comprised of a handle and PEEK anchor on a proximal (to user) edge of the inserter shaft.
The inserter shaft ends with a dedicated "fork" tip which holds the anchor. The handle is designed for hammering the inserter into the pilot hole to deploy the anchor. When the anchor is inserted into bone and the inserter is removed the fixation is achieved.
This is a 510(k) premarket notification for a medical device called the Betta Link™ Knotless Anchor System. This document does not pertain to an AI/ML device, therefore the requested information for acceptance criteria and study proving device meets the criteria is not applicable in the context of AI/ML performance.
The provided document describes a traditional medical device submission for a knotless anchor system used in soft tissue to bone fixation. The document focuses on demonstrating substantial equivalence to a predicate device through nonclinical testing (biocompatibility, sterilization, and various mechanical/functional tests) rather than AI/ML performance metrics.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as these aspects are not present in the provided text.
§ 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.