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The device is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract.

The injection needle is intended to be used with an endoscope to perform endoscopic vascular or submucosal injection in the GI tract, which consists of needle, connector tube, outer tube, outer tube, outer tube, protective sleeve, front handle, injection handle, front handle cover and boosting tube. The proposed device is used to puncture the target tissue where guided by the endoscope. The fluid is injected to the target through the proposed device by an injector which is connected the proposed device.

The provided text is a 510(k) summary for an Injection Needle, a medical device used with an endoscope for various injections in the GI tract. It does not describe an AI/ML-enabled device nor does it contain information about acceptance criteria or studies related to AI/ML device performance.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided document.

The document focuses on demonstrating substantial equivalence of the new Injection Needle to a predicate device (Single Use Injector NM600/610) based on non-clinical tests (biocompatibility, sterility, package integrity, etc.) and direct comparison of design and intended use specifications, as is common for traditional medical devices in a 510(k) submission. No clinical study was performed.

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