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The EG-3830UT, 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 organ; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced 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: Intra-luminal, Endoscopy.

The EG-3830UT, Ultrasound Video Gastroscope, must be used with a Pentax Video Processor (software controlled device) and must be used with an Ultrasound Diagnostic Scanner. The endoscope has a Flexible Insertion Tube, a Control Body, a PV Connector, and a Scanner Umbilical Connector. The PV Connector is connected at the Video Processor, and 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 for illumination, video signals, air/water and suction. 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 endoscope contains a charge couple device (CCD) to collect image data. The CCD is focused at the body cavity and the CCD collects image data for each strobe. The Video Processor stores the CCD information until all three color strobes are completed and a full color image is computed. The endoscope light carrying bundles present the color white light that is filtered, via a Red, Green, and Blue Color Wheel, at the Lightguide Prong. The ultrasound transducer delivers ultrasonic pulses, reflections of the pulses are processed by the Ultrasound Scanner for display. The instrument is immersable (That the Endoscope operator Manual cleaning instructions).

The provided text is a 510(k) summary for the Pentax EG-3830UT Ultrasound Video Gastroscope. It describes the device, its intended use, and a comparison to predicate devices, but it does not include detailed acceptance criteria or a study proving the device meets specific performance criteria.

Instead, the submission for substantial equivalence explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This indicates that a clinical study with acceptance criteria was not performed as part of this 510(k) submission. The FDA clearance is based on its substantial equivalence to previously cleared devices (K023401, K032503, K013722), meaning its technological characteristics and intended use are similar enough that it does not raise new questions of safety or effectiveness.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert adjudication, as this information is not present in the provided document.

Here's a summary of what can be extracted from the document regarding the "study" context, and why most of your questions cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

• Not applicable. The document explicitly states that the submission for substantial equivalence was not based on clinical performance data. Therefore, no acceptance criteria for performance and no reported performance against such criteria are provided.

2. Sample size used for the test set and the data provenance

• Not applicable. No test set or clinical study was conducted for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No ground truth was established from a test set as no clinical study was performed.

4. Adjudication method for the test set

• Not applicable. No test set or adjudication was performed.

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 applicable. This device is an Ultrasound Video Gastroscope, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

• Not applicable. This is a hardware device (gastroscope with ultrasound capabilities), not an algorithm.

7. The type of ground truth used

• Not applicable. No ground truth for performance assessment was established as no clinical performance study was conducted. The clearance is based on substantial equivalence to predicate devices, meaning their safety and effectiveness characteristics are considered similar enough.

8. The sample size for the training set

• Not applicable. This refers to machine learning models. The device is a medical instrument.

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

• Not applicable. This refers to machine learning models. The device is a medical instrument.

Key takeaway from the document: The 510(k) clearance for the EG-3830UT Ultrasound Video Gastroscope was based on its substantial equivalence to previously cleared predicate devices, as opposed to de novo clinical performance data and acceptance criteria specifically generated for this submission.

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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 FG-36UX, Fiber Ultrasound 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 Pediatric patient populations.

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

The endoscope has a flexible insertion tube, a control body, and Umbilicus is bifurcated where one endoscope nas a nextion miscrion table a contains connections for air/water and suction. The other umbilicus Connector is connected to the ultrasound scanner. The control body includes controls for up/ down/ left/ right angulation, an accessory elevator control, air/water delivery, suction selection/ control, forward water jet port, balloon insulflation, an accessory interport, and the endoscopic image viewing occular. The device contains light banoon insurration, an accessory inter port, another to optically visualize the anatomy, and an ultrasound transducer to collect ultrasonic image data. The instrument contains a working channel through which biopsy transacer of concer annasonia mage cause the instrument is supplied with two biopsy forceps). A convex linear devices, of other us views, may of and adoced (the pulses are received and signals are passed to the array transadeer dor 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 510(k) summary for the FG-36UX Fiber Ultrasound Gastroscope does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The 510(k) states that "The submission for substantial equivalence was not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to predicate devices based on specifications, optional accessories, and standard set components, rather than clinical performance studies with acceptance criteria.

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The EG-3830UT, 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 Pediatric patient populations.

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

The EG-3830UT, 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 Corvector. 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 I.ightguide 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).

Please note: The provided document is a 510(k) summary for a medical device (EG-3830UT Ultrasound Video Gastroscope and EUB-525 Ultrasound Diagnostic Scanner). As such, it focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed results of a study designed to meet specific acceptance criteria in the way one might find for a novel device or AI-powered solution.

Therefore, many of the requested details, particularly those related to acceptance criteria, specific performance metrics, sample sizes for training/test sets, expert ground truthing, and MRMC studies, are not available in this type of regulatory submission. The 510(k) process primarily relies on showing that the new device is as safe and effective as a legally marketed predicate device, often through technological comparison and established methods, rather than new clinical effectiveness studies with pre-defined acceptance criteria.

Based on the provided document, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for the device's diagnostic capabilities. Instead, the "acceptance criteria" for a 510(k) revolve around demonstrating substantial equivalence to a predicate device in terms of intended use, technology, and safety/effectiveness.

The document states:
"The submission for substantial equivalence was not based on an assessment of clinical performance data." This explicitly indicates that a study with defined performance acceptance criteria for the device itself was not conducted or provided in this submission.

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not applicable and not provided. The submission states that it was "not based on an assessment of clinical performance data."
• Data provenance: Not applicable. No clinical data presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No clinical data or ground truthing by experts was presented for a defined test set.

4. Adjudication method for the test set

• Not applicable. No clinical data or ground truthing process described.

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, an MRMC comparative effectiveness study was not done. This is explicitly stated by "The submission for substantial equivalence was not based on an assessment of clinical performance data." Furthermore, this device (from 2003) is an ultrasound video gastroscope and diagnostic scanner, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply.

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

• No, a standalone algorithm performance study was not done. This device is hardware (ultrasound video gastroscope and scanner) and software, providing imaging. It's not an algorithm intended for standalone diagnostic interpretation in the way "AI" often implies.

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

• Not applicable. No clinical data or ground truth derived from expert consensus, pathology, or outcomes data was used for assessing the device's performance in this submission. The "ground truth" for this 510(k) was the existence and safety/effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" for an algorithm.

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

• Not applicable, as there is no training set for an AI/machine learning model.

Summary of what the document does provide regarding substantial equivalence:

The document establishes substantial equivalence by:

• Intended Use Comparison: Demonstrating that the EG-3830UT and EUB-525 have the same intended use (optical and ultrasonic visualization, therapeutic access to the Upper GI Tract for adult and pediatric patients) as the predicate devices.
• Technological Characteristics Comparison: Providing a description of the device's components and functions, including the flexible insertion tube, control body, CCD for image data, and radial array ultrasound transducer, and stating that "comparison tables were provided to illustrate the comparisons to the predicated devices in summary." While the tables themselves are not included in this excerpt, the submission explicitly states such comparisons were made.
• Safety and Effectiveness: Implied by the comparison to legally marketed predicate devices shown to be safe and effective. The absence of new clinical performance data means the safety and effectiveness are derived from the predicate.

Predicate Devices:

• EG-3830UT, Video Ultrasound Gastroscope (Manufacturer: PPIC; PMN#: K023401)
• EUB-525, Ultrasound Diagnostic Scanner (Manufacturer: Hitachi America; PMN#: K981434)

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The EG-3830UT, 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 Pediatic patient populations.

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

The EG-3830UT, 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, 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 Lightenide Prong. The endoscope light carrying bundles present 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 document is a 510(k) summary for the PENTAX EG-3830UT Ultrasound Video Gastroscope, intended for use with the EUB-6000 and EUB-6500 Ultrasound Diagnostic Scanners. It details the device, its intended use, and a comparison to predicate devices, but does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document states: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This explicitly indicates that no clinical study was performed to assess the performance of the device against specific acceptance criteria.

Therefore, the following information cannot be extracted 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 the effect size of human readers improving with AI vs without AI assistance
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

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices based on specifications, components, and indications for use, rather than on new performance data against acceptance criteria.

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The EB-1830T3. Video Bronchoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Pulmonary Tract. The Pulmonary Tract includes, but is not restricted to, the organs; tissues; and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, and bronchial Tree (including access beyond the stem). The instrument is introduced per oral or per nasal when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.

The EB-1830T3. Video Bronchoscope, 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 and connections for suction. The umbilicus provides connection to the video processor. The control body includes controls for up/ down angulation, 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 an illumination system that is focused at the connected video endoscope lightguide prong. The endoscope light carrying bundles present the video processor illumination to the body cavity and the CCD collects image data and other screen display information are formatted and presented to the video outputs of the video processor for display.

The provided document is a 510(k) summary for the Pentax EB-1830T3 Video Bronchoscope, indicating its substantial equivalence to a predicate device. However, this document does not contain information on acceptance criteria or the study that proves the device meets those criteria, as it explicitly states that the submission for substantial equivalence was not based on an assessment of clinical performance data.

Therefore, I cannot provide the detailed information requested in your prompt based solely on the provided text. The document focuses on regulatory approval based on comparison to an existing device, rather than detailed performance study results.

Here's a breakdown of why each point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: Not available. The document states, "The submission for substantial equivalence was not based on an assessment of clinical performance data." This means performance metrics and acceptance criteria for those metrics are not presented.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical performance data assessment was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 applicable. This device is a bronchoscope, not an AI-assisted diagnostic tool, and no clinical performance studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (bronchoscope), not a standalone algorithm.
7. The type of ground truth used: Not applicable, as no performance data based on ground truth is presented.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set in that context.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (VB-1830, K934920) through comparisons of intended use, device description, and design control activities, without including performance data from a clinical study.

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The FG-36UX. Fiber Ultrasound 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 (Mode of Operation: B, M, Color Doppler, Amplitude Doppler)

The FG-36UX, Fiber Ultrasound Gastroscope, can be used with any Lightsource (with the appropriate lightguide receptacle) and must be used with Ultrasound Scanner (software controlled device). The endoscope has a flexible insertion tube, a control body, and Umbilicus is bifurcated where one connector is connected to the Lightsource and connections for air/water and suction. The other umbilicus bifurcation is connected at the ultrasound scanner. The controls for up/ down/ left/ right angulation, an accessory elevator control, air/water delivery, suction selection/ control, forward water jet port, balloon insufflation, an accessory inlet port, and the endoscopic image viewing ocular. The device contains light carrying bundles, one to illuminate the body cavity another to optically visualize the anatomy, and an 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). A convex linear array 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 FG-36UX Fiber Ultrasound Gastroscope and its associated FDA substantial equivalence letter. It describes the device, its intended use, and its comparison to predicate devices. However, this document does not contain any information about acceptance criteria, clinical studies, device performance metrics, sample sizes, ground truth establishment, or expert reviews.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other details about a study proving the device meets acceptance criteria, as this information is not present in the provided input.

The document explicitly states: "The submission for substantial equivalence was not based on an assessment of clinical performance data." This indicates that the 510(k) clearance was granted based on substantial equivalence to existing devices, without requiring a clinical study demonstrating performance against specific criteria.

Ask a specific question about this device

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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The FG-36UX, Fiber Ultrasound 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 There monded out is not room to introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

The FG-36UX, Fiber Ultrasound Gastroscope, can be used with any Lightsource (with the appropriate itemble insertion tube, a control body, and Umbilicus . The umbilicus is bifurcated where one connector is connected to the Lightsource and contains connections for air/water and suction. The other umbilicus Comments is connected at the ultrasound scanner. The control body includes controls for up/ down/ left/ right angulation an accessory elevator control, air/water delivery, suction selection/ control, forward water jet port, allyon insulflation, an accessory inlet port, and the endoscopic image viewing occular. The device contains light oundon insurrition, and to illuminate the body cavity another to optically visualize the anatomy, and an ultrasound carrying out 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). A convex linear array transducer delivers ultrasonic pulses, reflections of the pulses are received and signals are passed to the allay aunsation on for display. The instrument is immersable (with the use of supplied cleaning accessories) Onazound Deminer for Gisplay : The measur (as described in the Endoscope operator Manual cleaning instructions).

This looks like a 510(k) summary for a medical device, which typically describes the device, its intended use, and how it is substantially equivalent to a predicate device. It doesn't contain detailed information about a study proving the device meets specific acceptance criteria with performance metrics, sample sizes, and expert qualifications.

The document explicitly states: "The substantial equivalence was not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information because the document does not contain details about a study with acceptance criteria and device performance. The device's clearance was based on substantial equivalence to predicate devices, not on a new clinical performance study demonstrating direct fulfillment of specific performance metrics.

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