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The EG-3630UR, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy

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. The endoscope the PVE Connects to the Video Processor and has connections for illumination, video commoner and suction. The Scanner Connector is 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 marge 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 winte right 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 eonbes mage 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 is a 510(k) Summary for the EG-3630UR Ultrasound Video Gastroscope. It describes the device, its intended use, and its comparison to predicate devices for substantial equivalence.

However, the document explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical performance data."

This means that a study proving the device meets specific acceptance criteria based on performance (e.g., accuracy, sensitivity, specificity) was not included or relied upon for this 510(k) clearance. Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them because such a study was not presented in this submission.

The 510(k) process for this device focused on demonstrating substantial equivalence to legally marketed predicate devices primarily through comparison of specifications, standard components, and accessories, not through a clinical performance study. The FDA's clearance letter confirms this approach, stating, "We have determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a clinical performance study.

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The EG-3630UR, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediations.

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Endoscopy (B, M, Color Doppler, Amplitude Doppler modes of operation are new applications)

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 Insettion 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, may be introduced (the instrument is supplied with two biopsy forcessor 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 oolor 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 is a 510(k) summary for the PENTAX EG-3630UR, an Ultrasound Video Gastroscope. This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than directly presenting a study to prove acceptance criteria for the new device. Therefore, much of the requested information regarding a study proving acceptance criteria is not explicitly stated in this document.

However, based on the information provided, we can infer some details and state what is not present:

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

The document does not provide a table of acceptance criteria and reported device performance for the EG-3630UR. Instead, it states that the submission for substantial equivalence "was not based on an assessment of clinical performance data." This indicates that performance data against specific acceptance criteria for the new device was not a primary component of this particular 510(k) submission.

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

This information is not provided because the submission explicitly states it was "not based on an assessment of clinical performance data." Therefore, there would not have been a test set of data in the context of proving performance.

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)

This information is not provided. As mentioned, the submission was not based on clinical performance data, so no such experts or ground truth establishment for a test set are reported here.

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

This information is not provided.

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

This information is not provided. The device described is a physical endoscope with ultrasound capabilities, not an AI-assisted diagnostic tool.

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

This information is not provided. The device is a human-operated instrument, not an algorithm.

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

This information is not provided.

8. The sample size for the training set

This information is not provided. Since the submission was not based on clinical performance data, there is no mention of a training set for an algorithm or model.

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

This information is not provided.

Summary based on the provided text:

The provided 510(k) summary for the PENTAX EG-3630UR, an Ultrasound Video Gastroscope, is focused on establishing substantial equivalence to existing predicate devices (FG-36UX Fiber Ultrasound Gastroscope and EUB-6500 Ultrasound Diagnostic Scanner). It explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical performance data."

Therefore, the document does not contain the details of a study proving the device meets specific acceptance criteria in terms of clinical performance. The substantial equivalence argument typically relies on comparing technological characteristics, intended use, and safety/effectiveness principles to already legally marketed devices, rather than a de novo clinical performance study against pre-defined acceptance criteria.

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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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