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The USGI g- Cath Tissue Anchor Delivery Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures, e.g., fistula closure, perforation/leak closure and repair of dilated gastric tissue.

The g-Cath Tissue Anchor Delivery Catheter is a sterile, single patient use device that contains a nitinol/polyester tissue anchor pair within the catheter lumen. The anchor pair is deployed through the catheter lumen to compress and approximate tissue.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and related FDA correspondence for a medical device (g-Cath Tissue Anchor Delivery Catheter), primarily focusing on its description, intended use, and substantial equivalence to a predicate device for market clearance.

The text does not contain any details regarding:

• Acceptance criteria for device performance.
• A study design, sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided input.

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