(14 days)
The Mitek Panalok RC Loop Anchor is indicated for use in soft tissue to bone fixation in association with adequate post-operative immobilization as follows: Shoulder: Rotator cuff repair.
The Panalok RC Loop Anchor System is a preloaded absorbable disposable suture anchor/inserter assembly designed to allow soft tissue repair to bone with enhanced suture-sliding capabilities. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(L-lactide) polymer.
The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.
The document is a 510(k) summary for the Panalok RC Loop Anchor, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed performance studies against specific acceptance criteria.
Therefore, I cannot fulfill your request with the given input.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.