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The Ultrasound Video Gastroscope EG-3630UR is intended to provide ultrasonic and optical visualization of, and therapeutic access to, the Upper GI tract including esophagus, stomach, duodenum/small bowel in adult and pediatric patient populations.

The EG-3630UR, Ultrasound Video Gastroscope, must be used with a Pentax Video Processor (software controlled device) and must be used with Ultrasound Scanner (software controlled device). The endoscope has a Flexible Insertion Tube, a Control Body, PVE Umbilical Connector, and Scanner Umbilical Connector. The PVE Connector connects to the Video Processor and has connections for illumination, video signals, air/water and suction. The Scanner Connected at the Ultrasound Scanner. The Control Body includes controls for up/ down/ left/ right angulation, air/water delivery, suction selection/ control, balloon insufflation, and an accessory inlet port. The device contains light carrying bundles to illuminate the body cavity, a charge couple device (CCD) to collect image data, and a radial array ultrasound transducer to collect ultrasonic 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 lamp that provides white light that is filtered, via a Red, Green, and Blue color filter wheel, and is focused at the PVE Connector 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 image 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 ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are received and signals are passed to the Ultrasound Scanner for display. The instrument is immersable (with the use of supplied cleaning accessories) except for the Ultrasound Scanner Connector (as described in the Endoscope operator Manual cleaning instructions).

The provided text describes a 510(k) premarket notification for the "Ultrasound Video Gastroscope EG-3630UR". However, it explicitly states:

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

This means the submission did not include a study to prove the device meets acceptance criteria based on clinical performance. Instead, the substantial equivalence was based on a comparison of specifications, standard components, and optional accessories to predicate devices.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study proving these criteria, as such a study was not part of this 510(k) submission.

Summary of what can be derived from the provided text:

• Device: EG-3630UR, Ultrasound Video Gastroscope
• Intended Use: To provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract (Esophagus, Stomach, Duodenum, Small Bowel) in adult and pediatric patient populations.
• Basis for 510(k) Clearance: Substantial equivalence to predicate devices (FG-36UX, EG-2940, EPM-3300, EUB-525, EUB-6000) based on specifications and features, not clinical performance data.

Therefore, the following information is NOT available from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

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The EG-3400, Video Gastroscope, is intended to provide optical visualization (vja a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes, but is not limited to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Small Bowel. The instrument is introduced per orally when indications consistent with the requirement for procedure(s) are observed in Adult and Pediatric patient populations.

The EG-3400, Video Gastroscope, 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, 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 called the EG-3400, Video Gastroscope. It is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Based on the provided text, there is no information presented about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance.

The document explicitly states:

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

This single sentence directly indicates that no clinical performance study, and therefore no study that would involve acceptance criteria and reported device performance as requested in your prompt, was conducted or submitted for this particular 510(k) application.

Therefore, I cannot populate the table or answer the specific questions you've posed. The document is primarily focused on describing the device, its intended use, and its comparison to predicate devices based on specifications and components, not clinical performance.

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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.

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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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The EC-3840TL, Video Colonscope, 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-3840TL, 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 umbilious provides connection to the video processor. The control body includes controls for up/ downl left/ right angulation, air/water delivery, suction, forward water jet, 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.

This 510(k) summary for the Pentax EC-3840TL Video Colonoscope does not provide information on acceptance criteria or a study proving the device meets said criteria, as it explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information. The K961563 submission focuses on demonstrating substantial equivalence to predicate devices (EC-3800TL Video Colonoscope and EPM-3300 Video Processor) through device specifications, standard components, and accessories, rather than clinical performance studies with specific acceptance criteria.

The submission is from 1996, and regulatory requirements have evolved significantly since then. Modern 510(k) submissions for similar devices would typically include clinical performance data and detailed acceptance criteria.

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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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