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The EC-3840L/F, Video Colonoscope, is intended to provide visualization (via a video monitor) 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-3840LF, Video Colonoscope (L or F in model number denotes length), 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, Forward Water Jet, 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 510(k) summary describes a medical device, the EC-3840L/F, Video Colonoscope, and declares its substantial equivalence to previously cleared devices. It explicitly states that the submission for substantial equivalence was NOT based on an assessment of clinical performance data.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving the device meets those criteria because the provided text clearly indicates that no such studies were submitted or relied upon for this specific clearance.

Here's a breakdown of why each requested point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The submission explicitly states it was "not based on an assessment of clinical performance data."
2. Sample sized used for the test set and the data provenance: Not available. No clinical performance data was submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. No clinical performance data was submitted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available. No clinical performance data was submitted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available. This device is a video colonoscope, not an AI-assisted diagnostic tool. No clinical performance data was submitted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. This is a colonoscope, not an algorithm. No clinical performance data was submitted.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not available. No clinical performance data was submitted.
8. The sample size for the training set: Not available. This device is a colonoscope, not a machine learning algorithm. No "training set" of data would be relevant in this context.
9. How the ground truth for the training set was established: Not available. This device is a colonoscope, not a machine learning algorithm.

Conclusion:

The provided 510(k) summary for the PENTAX EC-3840L/F Video Colonoscope does not include information on acceptance criteria or studies proving device performance because its clearance was based on substantial equivalence to predicate devices, not on new clinical performance data. Therefore, all questions related to clinical study design, performance metrics, and data provenance cannot be answered from this document.

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