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The EG-3800T, Video Gastroscope, is intended to provide optical visualization (via 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-3800T, 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, two (2) accessory inlet ports, and a suction channel selector. The device contains light carrying bundles, to illuminate the body cavity, and a charge couple device (CCD) to collect image data. The instrument contains two (2) working channels 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 the Pentax EG-3800T, Video Gastroscope, and it indicates that the submission for substantial equivalence was not based on an assessment of clinical performance data. Therefore, it does not contain the information required to answer your request.

Specifically, the document does not describe an acceptance criterion or a study that proves the device meets any such criteria. It explicitly states that substantial equivalence was not based on clinical performance data.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number or qualifications of experts.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance.
7. Type of ground truth used.
8. Training set sample size.
9. How training set ground truth was established.

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