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The EG-3400, Video Gastroscope, is intended to provide optical visualization (vja a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes, but is not limited to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Small Bowel. The instrument is introduced per orally when indications consistent with the requirement for procedure(s) are observed in Adult and Pediatric patient populations.

The EG-3400, Video Gastroscope, must be used with a Video Processor (a software controlled device). The endoscope has a flexible insertion tube, a control body, and umbilicus. The umbilicus provides connection to the video processor. The control body includes controls for up/ down/ left/ right angulation, air/water delivery, suction, and an accessory inlet port. The device contains light carrying bundles, to illuminate the body cavity, and a charge couple device (CCD) to collect image data. The instrument contains a working channel through which biopsy devices, or other devices, may be introduced (the instrument is supplied with two biopsy forceps). The Video Processor contains a 300 watt xenon lamp which provides white light that is filtered, via a Red, Green, Blue color wheel, and is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the color strobes to the body cavity and the CCD collects image data for each strobe of color. The video processor stores the CCD information until all three color strobes are completed and a full color frame is compiled. Image data and other screen display information are formatted and presented to the video outputs of the video processor for display.

This document is a 510(k) summary for a medical device called the EG-3400, Video Gastroscope. It is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, there is no information presented about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance.

The document explicitly states:

"The submission for substantial equivalence was not based on an assessment of clinical performance data."

This single sentence directly indicates that no clinical performance study, and therefore no study that would involve acceptance criteria and reported device performance as requested in your prompt, was conducted or submitted for this particular 510(k) application.

Therefore, I cannot populate the table or answer the specific questions you've posed. The document is primarily focused on describing the device, its intended use, and its comparison to predicate devices based on specifications and components, not clinical performance.

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