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The EC-3800L, Video Colonoscope, is intended to provide optical visualization of, and therapeutic access to, the Lower Gastrointestinal Tract. The Lower Gastrointestinal Tract includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel. The instrument is introduced per rectally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

The EC-3800L, Video Colonoscope, 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, CO2 delivery, 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 is not medical device software. The provided text describes a traditional medical device (a video colonoscope) and not a software device that would typically have detailed acceptance criteria and a study proving those criteria as described in the prompt.

Therefore, I cannot extract the requested information from the provided text. The document refers to a "510(K) Summary" for a physical device, the "EC-3800L, Video Colonoscope," which was prepared on 02/04/95. This is a submission to the FDA for market clearance, where the device's equivalence to existing, legally marketed devices (predicates) is asserted.

Key points from the text confirming this:

• DEVICE: EC-3800L, VIDEO COLONOSCOPE - Clearly a hardware medical device.
• DATE SUMMARY PREPARED: 02/04/95 - This predates widespread use and regulation of complex AI/ML-driven medical device software for diagnostic purposes.
• The submission for substantial equivalence was not based on an assessment of clinical performance data. - This explicitly states that clinical performance studies (which would typically involve acceptance criteria and efficacy evaluation) were not the basis for clearance. Instead, substantial equivalence to predicate devices (FC-38LA Fiber Colonoscope, VB-1530/1830 Video Bronchoscope, EPM-3300 Video Processor) was the claim.
• Device Description: Describes physical components like "flexible insertion tube," "control body," "umbilicus," "light carrying bundles," and "charge coupled device (CCD)."

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