Search Results

The ED-3440T, Video Duodenoscope, is intended to provide 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 restricted 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-3440T, 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/ downl left/ right angulation, air/water delivery, suction, elevator control lever, 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 prone. 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 for the Pentax ED-3440T Video Duodenoscope does not contain the information required to populate a table of acceptance criteria and reported device performance, nor does it describe a study that proves the device meets acceptance criteria.

The document explicitly states:

"The submission for substantial equivalence was not based on an assessment of clinical performance data."

This means that no clinical study was conducted or reported to demonstrate the device meets any specific performance criteria. The submission relied on comparisons to previously cleared predicate devices (Pentax EC-3800L, Pentax FD-34A, Pentax EPM-3300) based on specifications, standard components, and optional accessories, rather than clinical performance data.

Therefore, for all the requested sections, the answer is that the information is not provided in the given document.

Here's a breakdown of why each section cannot be answered:

1. A table of acceptance criteria and the reported device performance:

   • No acceptance criteria are mentioned.
   • No reported device performance data is provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • No test set or clinical study is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • No test set or clinical study is mentioned, thus no ground truth experts were involved.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • No test set or clinical study is mentioned, thus no adjudication method was used.

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:

   • No MRMC study was done, and AI is not mentioned as part of this device. This is a video duodenoscope, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This is a medical device (duodenoscope), not an algorithm. Standalone performance is not applicable in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • No ground truth was established as no clinical performance data was provided.

8. The sample size for the training set:

   • No training set is mentioned as no clinical performance data was provided.

9. How the ground truth for the training set was established:

   • No training set is mentioned and no ground truth was established.

Ask a specific question about this device