(69 days)
The SyndesMetrics Syndesmosis Repair System is intended for repair in the ankle including indications for:
Ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures.
The SyndesMetrics Syndesmosis Repair System consists of a Fibular Anchor and a Tibial Anchor which are connected by a length of suture. The implant is marketed with previously cleared ultra-high molecular weight polyethylene (UHMWPE) 3.5mm OrthoTape® (K150438) which is provided sterile packaged from Teleflex, Inc.
The provided text describes a medical device, the SyndesMetrics Syndesmosis Repair System, and its 510(k) submission to the FDA. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.
The document is a 510(k) clearance letter for a physical medical device (SyndesMetrics Syndesmosis Repair System) that is intended for ankle syndesmosis fixation. The clearance is based on substantial equivalence to predicate devices, and the supporting data are non-clinical (mechanical testing).
Therefore, I cannot provide the requested information because the input text does not describe an AI/ML-based device or a study with acceptance criteria related to its performance. The "Nonclinical Testing" section explicitly states: "Clinical data were not needed to support the safety and effectiveness of the subject device."
§ 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.