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The ED-3410, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract and Biliary Tract. The Upper Gastrointestinal Tract and Biliary Tract includes, but is not limited to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile Duct, Hepatic Duct, and Cystic Duct. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

The ED-3410, Video Duodenoscope, 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, elevator control, 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 (ED-3410, Video Duodenoscope) submitted to the FDA in 1996. The information provided is primarily for regulatory clearance and device description, not a clinical study report with acceptance criteria and performance data.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies because this information is not present in the provided text.

The document explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This means a study demonstrating the device meets specific performance criteria, as you've outlined, was not conducted or submitted for this particular regulatory filing.

The 510(k) summary focuses on comparing the ED-3410 to predicate devices to establish substantial equivalence based on technological characteristics and intended use, rather than presenting clinical trial results.

In summary, none of the requested information regarding acceptance criteria and performance studies can be provided from the given text.

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