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This video enteroscope is for the optical visualization of the upper gastrointestinal tract. This includes the Esophagus, Stomach, Duodeum and Small Bowel. It is intended for observation, diagnosis and endoscopic treatment.

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The provided text is a 510(k) clearance letter and an "Indications for Use" statement for a medical device called the "GASTRO INTESTINAL SYSTEM EN-410WM." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the information requested regarding acceptance criteria, device performance, study design, sample sizes, ground truth establishment, or expert involvement.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

This means the device's clearance is based on its substantial equivalence to an existing FDA-approved device, not on a new, comprehensive clinical study demonstrating specific performance metrics against defined acceptance criteria. The 510(k) pathway often relies on demonstrating that a new device performs as intended and is as safe and effective as a predicate device, rather than requiring extensive new clinical trial data that would rigorously establish acceptance criteria and performance against them as would be seen in a premarket approval (PMA) application.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, and performance metrics as this information is not present in the provided text.

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