(86 days)
TriMed Ripcord devices are intended for use to supplement repair or during healing of ligament injuries or deficiencies of the extremities.
The TriMed RipCord device is indicated to be used as an adjunct in combination with compatible TriMed fixation implants to provide fixation during the healing process in syndesmotic trauma, such as fixation of syndesmosis disruptions in connection with Weber B and C ankle fractures.
The TriMed RipCord Suture Button implant (RipCord Device) is a non-bioabsorbable suture/button implantable device used as an aid for the treatment of ligament injuries, deficiencies, or reconstruction. The TriMed RipCord Suture Button Implant comprises of, a far side 316L stainlesssteel Button, near side 316L stainless-steel button, and ultra-high molecular weight polyethene (UHMWPE) braided suture. The implantable device is packaged with various ancillary instruments to aid in insertion. The implantable devices and various ancillary instruments are provided sterile and are single use.
This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI performance, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not applicable to this document.
The document provided describes a TriMed RipCord Device, which is a non-bioabsorbable suture/button implantable device used for ligament injuries. The submission focuses on demonstrating substantial equivalence to a predicate device based on non-clinical performance data (mechanical testing) and technological characteristics, not a clinical study involving AI.
Specifically, the document states:
- "Clinical testing was not necessary for the determination of substantial equivalence." (Page 4, Section (b)(2))
- The device was tested for cyclic endurance, static load displacement, pull-through needle testing, cyclical shear endurance, bacterial endotoxins, cytotoxicity, sensitization, and irritation. These are mechanical and biocompatibility tests, not AI performance evaluations.
- The conclusion for substantial equivalence is based on "mechanical testing data demonstrates that the cyclic fatigue, maximum static loading, needle pull through, and cyclical shear of the subject device is substantially equivalent to that of the predicate device for the desired indications." (Page 4, Section (b)(3))
Therefore, I cannot extract the requested information as it is not present in 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.