(153 days)
The Stainless Steel Soft Suture Wire is intended for general orthopedic surgery such as Sternulli Closure, nature bones and patella fracture fixation. The device is also intended for soft tissue approximation such as abdominal wound closure and hernia repair.
Suture Wire (87 LRN)
This document is a 510(k) clearance letter from the FDA for a medical device called "Stainless Steel Soft Suture Wire." It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria, device performance studies, or details regarding ground truth, expert opinions, or sample sizes.
Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the input document. The document is a regulatory approval, not a technical report detailing performance studies.
§ 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.