Search Results

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with the PENTAX Medical camera heads, endoscopes, light sources, monitors ancillary equipment for gastrontestinal and pulmonary endoscopic diagnosis, treatment and video observation.

The PENTAX Medical EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX i-ScanTM), and optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX Medical video gastrointestinal endoscopes and bronchoscopes.

The PENTAX Medical Video Processor EPK-i8020c is intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. The video processor consists of a video system, integrated light source, monitor, and ancillary equipment.

The EPK-i8020c includes a digital post-processing imaging enhancement technology (PENTAX Medical i-scan™) and an optical imaging enhancement technology (OE). These post-imaging functions are not intended to replace histopathological sampling.

The brand name "INSPIRA™" is provided for the EPK-i8020c video processor and the name is found in the instructions for use (IFU) and/or in the commercial materials such as brochures.

The provided text describes the 510(k) submission for the PENTAX Medical Video Processor EPK-i8020c. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with a defined ground truth.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not explicitly provided in the document, as the submission relies on non-clinical performance data and a comparison to an already cleared predicate device.

However, I can extract information related to the device's performance testing and the nature of the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test set sample size: Not specified. The document refers to "performance testing" and an "animal image capture study" but does not quantify the number of cases or animals involved.
• Data provenance: For the "animal image capture study," the data provenance is from an animal study. The country of origin is not specified but implicitly assumed to be from within PENTAX Medical's research and development. This was a non-clinical study.

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

• Not applicable/Not specified. The animal study evaluated the device's ability to "visualize vascularity and mucosal surface," implying an objective assessment rather than a diagnostic interpretation requiring expert ground truth establishment for a specific medical condition. The study aimed to assess optical and color performance.

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

• Not applicable/Not specified. Given the nature of the "animal image capture study" for optical and color performance, an adjudication method for diagnostic agreement with a ground truth is not described as the primary objective was visualization capability comparison.

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. The device (PENTAX Medical Video Processor EPK-i8020c) includes "digital post-processing imaging enhancement technology (PENTAX i-Scan™)" and "optical imaging enhancement technology (OE)." However, the submission does not describe a human-in-the-loop study to evaluate the effectiveness of these enhancements or how human readers' performance improves with or without these features. The statement is that these technologies are "intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling."

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

• A standalone performance assessment was done for various system components, including software and optical performance. The "animal image capture study" can be considered a standalone assessment of the device's imaging capabilities (optical and color performance) in a biological setting, comparing it to predicate/reference devices. This was an evaluation of device capability itself, not an algorithm's diagnostic output.

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

• For the "animal image capture study," the "ground truth" was the objective presence of vascularity and mucosal surface in the animal model. The assessment was likely based on the visual quality and clarity of these features as captured by the device, compared to the predicate and reference devices. It was not a ground truth for a diagnostic condition established by pathology or expert consensus.

8. The sample size for the training set:

• Not applicable/Not specified. This submission does not describe a machine learning algorithm that would require a distinct training set. The device contains "digital post-processing imaging enhancement technology (PENTAX i-Scan™)," which might involve algorithms, but the development and training of these are not detailed as part of this 510(k) submission.

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

• Not applicable/Not specified, as no training set is discussed in this context.

Ask a specific question about this device

The PENTAX Medical EG-J10U Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

The PENTAX Medical EG-J10U Endoscopic Ultrasound System (Proposed) includes three endoscope models EG34-J10U. EG36-J10UR, and EG38-J10UT Ultrasound Upper GI Video Scopes, and is used to provide visualization of, and therapeutic access to, the upper gastrointestinal tract. They are used with FDA cleared PENTAX Medical Video Processors (a software-controlled device) and FDA cleared Hitachi Ultrasound Scanners (a softwarecontrolled device). The endoscopes have a flexible insertion tube, a control body, PVE umbilical connector, and ultrasound scanner umbilical connector. The PVE umbilical connector will be attached to the Video Processor and has connections for illumination, video signals, air, water, and suction. The ultrasound scanner umbilical connector will be attached to the ultrasound scanner unit. A sterile, single use disposable natural rubber latex balloon is fitted over the convex array ultrasound transducer prior to the procedure. During an ultrasound endoscopy procedure, the latex balloon is inflated with water. The water that is contained within the balloon creates a water field that covers the transducer. The water field enables more effective transport of ultrasonic pulses from the ultrasound transducer to the target anatomical site and back to the ultrasound transducer. The control body includes controls for up/ down/ left/ right angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles to illuminate the body cavity, a charge coupled device (CCD) to collect endoscopic image data, and a linear or 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 video processor contains a lamp that provides white light and is focused at the PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. 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 the signals are passed to the ultrasound scanner for processing and display. EG34-J10U, EG36-J10UR, and EG38-J10UT Ultrasound Upper GI Video Scopes are connected to the ultrasound scanner ARIETTA 70 and the ALOKA ARIETTA 850 via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector. The instrument is immersible (with the use of supplied cleaning accessories) except for the ultrasound scanner connector (as described in the endoscope Operators Manual cleaning instructions).

The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (Proposed) connects with a video processor and an ultrasound scanner, both of which are software-controlled devices. The endoscope has a flexible insertion tube, a control body, PVE connector, and scanning unit connector. The PVE connector attaches to the video processor and has connections for illumination and video signals. The ultrasound umbilical connector attaches to the ultrasound scanner unit. The control body includes remote buttons for functions assigned from the video processor. It also includes controls for up/down angulation or neutral position control, and ports for manual balloon insufflation/evacuation, and an accessory inlet. The endoscope contains light carrying bundles to illuminate the body cavity, a charge coupled device (CCD) to collect endoscopic image data, and a convex 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 video processor contains a lamp that provides white light focused at the endoscope PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. 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 the signals are passed to the ultrasound scanner for processing and display. The instrument is immersible (with the use of supplied cleaning accessories). EB19-J10U is connected to the ultrasound scanners ARIETTA 70, ALOKA ARIETTA 850, and Noblus via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector.

The provided text appears to be a 510(k) summary for medical devices, specifically endoscopic ultrasound systems and a video bronchoscope, from PENTAX of America, Inc. It describes the devices, their indications for use, and a comparison to predicate devices, focusing on the addition of compatibility with a new diagnostic ultrasound system (ALOKA ARIETTA 850).

However, the document does not contain specific acceptance criteria or a study design in the way one might expect for a clinical performance study measuring diagnostic accuracy (e.g., sensitivity, specificity, AUC) or human reader improvement with AI assistance. Instead, it focuses on engineering and performance testing to demonstrate substantial equivalence to predicate devices after a minor modification (compatibility with a new ultrasound scanner).

Therefore, a table of acceptance criteria and reported device performance as typically understood for diagnostic accuracy would be largely inapplicable here. The "performance data" section details verification/validation methods used to mitigate identified risks, which serve as the acceptance criteria for these specific engineering tests.

Here's an attempt to answer your questions based on the provided text, acknowledging the nature of the submission:

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

Based on the provided text, the "acceptance criteria" are the satisfaction of relevant international standards and the reported "performance" is that the devices passed these checks.

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

The text describes engineering, electrical safety, and acoustic output testing. It does not involve a "test set" of patient data or clinical images. The testing was conducted on the devices themselves or their interaction with the new ultrasound scanner. Therefore, typical patient-data related sample size and provenance information are not applicable.

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)

Not applicable. The ground truth for this type of engineering and performance testing is established by compliance with international standards and technical specifications, not by expert clinical consensus on patient data.

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

Not applicable. There was no clinical test set requiring adjudication. The verification and validation activities were based on standardized measurements and testing protocols.

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. This submission is for an endoscopic ultrasound system and video bronchoscope with a minor modification (compatibility with a new diagnostic ultrasound system), not an AI-assisted diagnostic tool.

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

Not applicable. The devices are visualization tools for human operators, not standalone algorithms.

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

The "ground truth" in this context is the compliance with established international standards and FDA guidance for medical device safety and performance. This includes:

• IEC 60601-2-37: 2007 +A1: 2015 (Electrical safety standard for ultrasonic medical diagnostic and monitoring equipment)
• IEC 60601-1-2: 2014 (EMD standard for medical electrical equipment)
• FDA guidance, "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers"

8. The sample size for the training set

Not applicable. This submission is for hardware devices (endoscopes) and their compatibility, not for an AI algorithm that requires a training set.

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

Not applicable, as there was no training set for an AI algorithm.

Ask a specific question about this device

The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.

Intended use: Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows.
Clinical Application: Endoscopy
Mode of Operation: B, M, PWD, Color Doppler, Amplitude Doppler

The PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U connects with a video processor and an ultrasound scanner, both of which are software controlled devices.

The endoscope has a flexible insertion tube, a control body, PVE connector, and scanning unit connector. The PVE connector attaches to the video processor and has connections for illumination and video signals. The ultrasound umbilical connector attaches to the ultrasound scanner unit.

The control body includes remote buttons for functions assigned from the video processor. It also includes controls for up/down angulation or neutral position, suction control, and ports for manual balloon insufflation/evacuation and accessory inlet.

The endoscope contains light carrying bundles to illuminate the body cavity, a change couple device to collect endoscopic image data, and a convex 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 video processor contains a lamp that provides white light focused at the endoscope PVE connector light guide prong. The endoscope light carrying bundles present the light to the body cavity and the CCD collects endoscopic image data. 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 the signals are passed to the ultrasound scanner for processing and display. The instrument is immersible (with the use of supplied cleaning accessories). EB19-J10U is connected to the ultrasound scanners Arietta 70 and Noblus via the scanning unit connector of the endoscope directly to the probe connector of the scanning unit. In order to connect to the Preirus scanning unit, junction box PUN-JBP1 is required to connect the scanning unit connector to the probe connector.

The instrument is immersible (with the use of supplied cleaning accessories).

The provided text is a 510(k) Summary for the PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U. It details the device's technical specifications, intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, it does not contain any information about a study proving that the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, accuracy, or reader performance with or without AI assistance.

The document focuses on non-clinical testing to demonstrate that the device is equivalent to a legally marketed predicate device, especially regarding safety and effectiveness from a design and manufacturing perspective. It mentions "Performance Testing - Bench" for "System compatibility" and "Optical characteristics," but does not provide specific acceptance criteria or quantitative results for these tests.

Therefore, I cannot fully answer your request for acceptance criteria and a study that proves the device meets them, as the provided text does not include the necessary information regarding a clinical performance study involving AI, human readers, or specific diagnostic performance metrics.

Here's an breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document lists various types of non-clinical testing (Sterilization, Reprocessing, Biocompatibility, Software, EMC + Electrical Safety, System Compatibility, Optical Characteristics), and states that "Testing results confirm the subject device is safe and effective as the predicate device, and performs as intended." However, it does not provide specific quantitative acceptance criteria or detailed numerical results for these tests. For example, it says "The subject device demonstrates equivalent or better optical characteristics than the predicate device," but gives no numerical value for either.

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

• Cannot be provided definitively for a performance study. The document outlines non-clinical bench testing. These tests typically don't involve "samples" in the same way clinical studies do (e.g., patient data). The data provenance (country of origin, retrospective/prospective) is not applicable or mentioned for the types of tests described.

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

• Not applicable. This information is relevant for studies establishing diagnostic ground truth, often used for AI/clinical performance evaluations. The document describes engineering and safety testing, not clinical diagnostic performance.

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

• Not applicable. Adjudication methods are used in clinical studies to resolve discrepancies in expert interpretations for ground truth establishment. This document doesn't describe such a study.

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, such a study was not done according to this document. This device is a bronchoscope, which is a physical instrument for visualization and access, not an AI software intended to assist human readers in image interpretation. The document does not mention any AI component or any MRMC studies.

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

• No, this is not an AI algorithm. This is a hardware device (bronchoscope) with associated software for its operation. Therefore, a standalone algorithm performance study is not applicable.

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

• Not applicable in the context of diagnostic performance. The "ground truth" for the tests described relates to engineering specifications and safety standards (e.g., whether the device sterilizes correctly, whether electrical current is within safe limits, whether optical clarity meets design specs).

8. The sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is not an AI device being trained.

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

• Not applicable. (See point 8).

In summary, the provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of a medical device (a bronchoscope) through non-clinical testing of its physical, electrical, and reprocessing characteristics. It does not involve AI or diagnostic performance studies that would require the types of acceptance criteria and study details you requested for AI-driven devices.

Ask a specific question about this device