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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.

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