(198 days)
The Smith & Nephew SURETAC® Fixation Device is indicated for rotator cuff repair.
The PGA/TMC SureTac is composed of bioresorbable and biocompatible polymers that have been used in various surgical procedures for many years. Polyglycolic Acid (PGA) and Trimethylene carbonate (TMC) copolymer degrades and resorbs In Vivo by hydrolysis and are metabolized by the body. In animal studies PGA/TMC, also know as, Maxon have been shown to be biocompatible in both soft tissue and bone tissue.
The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, data provenance, expert ground truth, adjudication methods, or MRMC studies. The document is a 510(k) summary for a medical device (SURETAC® Expanded Indication II) focusing on its substantial equivalence to previously marketed predicate devices for the indication of rotator cuff repair.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.
§ 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.