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The Disposable Polyp Snare is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract. The snare can be used with or without high-frequency current.

The subject device is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract.

The subject device consists of a handle section, a tube section and a loop section. The loop section is inserted into the tube section and is extended and retracted by operating the handle section.

The tube section and the loop section are inserted into the gastrointestinal tract through the endoscope. The loop is extended from the tube to resect the target tissue. The resection is performed with or without high-frequency current.

The shape of the loop includes oval, crescent, hexagonal, rhombus, dual-width oval, and polygonal. Users can choose the shape of the snare according to their preference and the characteristic of the lesion.

The provided text is a 510(k) summary for a medical device (Disposable Polyp Snare) and does not contain information about software as a medical device (SaMD) or an AI/ML device. Therefore, it does not describe acceptance criteria, the study that proves a device meets those criteria, or the other specific details requested in the prompt related to AI/ML or SaMD performance.

The document pertains to a physical medical device and its substantial equivalence to a predicate device based on non-clinical performance testing. The "510(k) Summary," specifically section 8 "Summary of non-clinical testing," outlines the tests conducted to support its marketing claims and confirm safety and effectiveness.

Based on the provided text, I cannot provide the requested information for the following reasons:

• Device Type: The device is a "Disposable Polyp Snare," which is a physical endoscopic accessory, not an AI/ML or software device.
• Study Type: The document explicitly states "No clinical tests were performed" (Section 9). The "non-clinical testing" summarized in Section 8 refers to physical performance tests (e.g., strength, maneuverability, cutting ability), sterilization, shelf-life, biocompatibility, and electrical safety, not the performance of an AI algorithm.
• Ground Truth/Experts/Sample Size (for AI): Since this is not an AI/ML device, there is no mention of training sets, test sets for AI performance, expert consensus for ground truth, or adjudication methods for AI performance evaluation.

In summary, the provided document does not contain the type of information needed to answer your detailed questions about acceptance criteria and study data for an AI/ML or SaMD product.

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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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