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The EC-3800TL, Video Colonscope, 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-3800TL, 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/ downl left/ right angulation, air/water delivery, suction, two (2) accessory inlet ports, and 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.

The provided text describes a 510(k) summary for the PENTAX EC-3800TL Video Colonoscope, cleared in 1995.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

Based on the provided document, no information is available regarding acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI or diagnostic accuracy.

The document is a 510(k) submission summary for a video colonoscope, focusing on its design, intended use, and comparison to predicate devices for substantial equivalence. It predates the widespread use of AI in medical devices and focuses on the physical and functional aspects of the scope itself, not on diagnostic performance metrics or human-AI interaction.

Therefore, I cannot populate the requested information because the provided text does not contain it.

Here's a breakdown of why this information is missing:

• Type of Device: The EC-3800TL is a video colonoscope, a physical instrument for visualization and therapeutic access. This submission focuses on its hardware specifications and safety, not on diagnostic algorithms or performance metrics of AI in interpreting images.
• Date of Submission (1995): This predates the typical application of AI in medical imaging interpretation, especially regarding performance studies with human readers, ground truth establishment, and large datasets for training/testing.
• Focus of 510(k) Submission: The document explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This further confirms that no performance study, as you've requested, was conducted or presented in this summary.

Therefore, I cannot create the table or answer the specific questions about acceptance criteria, sample sizes, expert involvement, or AI-related studies because the provided document does not contain this information.

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