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The FiberStitch™ Meniscal Repair Device is intended for use as a suture retention device to facilitate endoscopic soft tissue procedures.
The FiberStitch™M Meniscal Repair Device is indicated for use in meniscal repair procedures.

The FiberStitch™ devices are an all-inside meniscal repair device. The devices include two non-absorbable polyester implants, pre-tied with #2-0 non-absorbable sutures and preloaded into a needle delivery system. The adjustable depth penetration limiter is preset to approximately 18mm from the tip of the needle. It can be adjusted down in 2 (mm) increments to approximately 10mm.

I am sorry, but the provided text describes a medical device called "FiberStitch™ Implant" and its 510(k) summary for FDA clearance. This document outlines the device's indications for use, comparison to predicate devices, and nonclinical testing that was performed.

However, the text does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML-driven medical device, which would typically involve performance metrics like sensitivity, specificity, AUC, etc., derived from a test set with established ground truth.

Therefore, I cannot provide the requested information in the format you specified. The information about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this regulatory document for this type of medical device.

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