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The PENTAX Medical Video Bronchoscopes EB-J10 Series have been designed to be used with a PENTAX Video Processor (including Light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopic surgery within the airways and tracheobronchial tree.

The EB-J10 series endoscopes are used to provide visualization of, and therapeutic access to, the airways and tracheobronchial tree. There are two models of EB-J10 series: EB15-J10 and EB19-J10. These models are identical in all parameters and only differ in French size: 15 and 19.

The bronchoscopes are used with cleared PENTAX Video Processors (a softwarecontrolled device). The endoscopes have a flexible insertion tube, a control body, and PVE connector. The PVE connector will be attached to the Video Processor and has connections for illumination, video signals, air/ water and suction.

The control body includes controls for up/ down angulation, air/ water delivery, and an accessory inlet port. The endoscope contains light carrying bundles (LCB) to illuminate the body cavity, and a charge coupled device (CCD) to collect endoscopic 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 instrument is immersible (with the use of supplied cleaning accessories) as described in the endoscope reprocessing instructions.

Here's a summary of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the clinical image capture study (test set) or its specific provenance (e.g., country of origin, retrospective/prospective). It only mentions that "A clinical image capture study was performed."

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

This information is not provided in the document. The document only mentions "visualization of vascularity and mucosal surface for each anatomical area" as the outcome of the clinical image capture study, implying expert assessment, but no details about the experts are given.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The clinical image capture study primarily aimed to compare the visualization capabilities of the subject device against the predicate, not to assess human reader performance with or without AI assistance.

6. Standalone Performance Study

A standalone performance study (algorithm only without human-in-the-loop) was not performed as the device is a bronchoscope, which is a physical instrument used by a clinician, not an AI algorithm. The performance tests focused on the physical and optical characteristics of the device itself.

7. Type of Ground Truth Used

For the clinical image capture study, the "ground truth" was likely based on expert assessment of the bronchoscope's ability to clearly visualize vascularity and mucosal surface. However, the document does not explicitly state the methodology for establishing this ground truth (e.g., expert consensus, pathology, etc.). The other tests (reprocessing, software, EMC, optical) used established engineering standards and measurements as their "ground truth".

8. Sample Size for the Training Set

This information is not applicable and not provided. The PENTAX Medical Video Bronchoscope EB-J10 Series is a medical device, specifically a bronchoscope, and not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this device.

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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.

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PENTAX Medical ENT Video Imaging System consists of PENTAX Medical Video Naso-Pharyngo-Laryngoscopes, PENTAX Medical Video Processor, PENTAX Medical Digital Video Capture Module, PENTAX Medical Laryngeal Strobe and other ancillary equipment.

1. PENTAX Medical Video Naso-Pharyngo-Laryngoscope
   The PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL8-J10, VNL11-J10 and VNL15-J10) is intended to be used with a PENTAX Medical Video Processor, PENTAX Medical Laryngeal Strobe, documentation equipment, video monitor, endoscopic device and other ancillary equipment for optical visualization (via a video monitor) of, and, for VNL15-J10 only, therapeutic access to, nasal, pharyngeal, laryngeal and the upper airway anatomy.

2. PENTAX Medical Video Processor
   The PENTAX Medical Video Processor (EPK-i5010) is intended to be used with the PENTAX Medical camera heads, PENTAX Medical VNL-1570STK, VNL8-10, VNL11-J10, and VNL15-J10 endoscopes, PENTAX Medical Laryngeal Strobe, video monitors and other ancillary equipment for ENT endoscopic observation and naso-pharyngo-laryngoscopic (ENT) diagnosis, treatment and video observation with or without stroboscopy.

The PENTAX Medical EPK-i5010 Video Processor includes PENTAX i-Scan™, a digital, post-processing imaging enhancement technology.

PENTAX Medical ENT Video Imaging System is used for ENT endoscopic observation and nasopharyngolaryngoscopic (ENT) diagnosis, treatment, and video observation.

The System functions by receiving image signals from the image sensor in an endoscope, which are processed within a video processor and then output to a monitor. Brightness, color balance, and other properties of the displayed images can be adjusted using the buttons on the system's control panel. The light at the distal end of the endoscope illuminates the body cavities of the patient through the endoscope connected to the video processor.

The primary components of the system include the following:

• PENTAX Medical Video Processor EPK-i5010
• PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-1570STK
• PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL-J10 Series (VNL-J10 Series)
• PENTAX Medical Laryngeal Strobe 9400
• PENTAX Medical Digital Video Capture Modules (two models are available: 9310HD/937HD)

The provided document describes the PENTAX Medical ENT Video Imaging System and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific quantitative acceptance criteria alongside performance data for individual parameters (e.g., specific signal-to-noise ratio values). Instead, it states that "The acceptance criteria have been satisfied for all tests" for system interoperability and that "Based on the tests results, the optical performance of the subject device is substantially equivalent to that of the predicate device."

Here's a summary of the evaluated parameters and the general conclusion:

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: The document refers to a "library of images" being captured for evaluation. However, it does not specify the exact number of images or cases used in this "library."
• Data Provenance: The document does not explicitly state the country of origin. It indicates that it was a "non-significant risk clinical study with IRB approval," which suggests a prospective clinical study, though the specifics of the patient population are not provided beyond the scope of image evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Number of Experts: The document states that the images were "evaluated by experienced ENT physicians." The exact number of experts is not specified.
• Qualifications of Experts: They are described as "experienced ENT physicians." Specific details such as years of experience or board certification are not provided.

4. Adjudication Method for the Test Set

The document states that the images were "evaluated by experienced ENT physicians" and that the "subject devices were evaluated as having equivalent ability to visualize vascular structure and/or mucosal surface." This implies a subjective assessment, but it does not detail any specific adjudication method (e.g., 2+1, 3+1 consensus).

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

The study described is a comparative visualization study between two imaging systems (subject vs. predicate). It is not an MRMC comparative effectiveness study involving AI assistance. The PENTAX i-Scan™ is a digital, post-processing imaging enhancement technology included in the video processor, but the study focuses on the overall performance of the imaging system and does not specifically measure human reader improvement with or without AI (i-Scan) assistance in the context of an MRMC study.

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

No, a standalone algorithm-only performance study was not explicitly described. The clinical performance data presented involves human interpretation ("evaluated by experienced ENT physicians"). The i-Scan technology is an integrated enhancement, not a separate AI algorithm being evaluated for standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical performance evaluation was based on the subjective assessment/evaluation of "experienced ENT physicians" regarding the visualization ability of vascular structure and/or mucosal surfaces. It is not explicitly stated to be an expert consensus of a specific number of experts, nor is it based on pathology or outcomes data from the patients.

8. The Sample Size for the Training Set

This document describes a premarket notification for a medical imaging system, not an AI/ML device that requires a distinct training set for an algorithm. Therefore, no training set sample size is mentioned or applicable in the context of an algorithm. The "library of images" mentioned pertains to the evaluation (test) set for demonstrating equivalence.

9. How the Ground Truth for the Training Set Was Established

As this is not an AI/ML device with a distinct training set for an algorithm, this question is not applicable. The "ground truth" discussed in the performance study relates to the evaluators' assessment of image quality from the captured library of images.

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