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The device is used for endoscopic clip placement within the gastrointestinal(GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3cm, bleeding ulcers, arteries less than 2mm, polyps less than 1.5cm in diameter and diverticula in the colon. Anchoring to affix jejunal feeding tubes to the wall of the small bowel. Closure of Gl tract lumenal perforations less than 20mm that can be treated conservatively.

The Single Use Hemoclip is a sterile, single use device that consists of metal clip that detaches from the introducer to maintain approximation of tissue to achieve hemostasis and endoscopic marking in the gastrointestinal tract. The device is provided sterile (EO). The large clip opening design meets various clinical treatment demands. It can be opened and closed repeatedly and can achieve repositioning. The 360 rotatable design is convenient for clinical use. lt consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

The provided document is a 510(k) summary for a medical device (Single Use Hemoclips) and does not describe a study involving acceptance criteria and device performance in the context of AI or software. Instead, it details the substantial equivalence of the subject device to a predicate device through non-clinical bench testing.

Therefore, I cannot provide the requested information about acceptance criteria and study details related to device performance, sample sizes, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, training set details, or how ground truth was established for a study because this information is not present in the given text.

The document focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance by the FDA.

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