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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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria Category	Specific Criteria/Tests Performed	Reported Device Performance
Reprocessing Validation	Simulated use testing, soil accumulation analysis, cleaning, high-level disinfection, and rinsing validation	Confirmed effectiveness of reprocessing procedures.
Sterilization & Shelf Life	Validate STERRAD NX/100NX for sterilization,
Electron Beam Sterilization for packaging and single-use valve	3-year shelf-life verified. Devices not provided sterile.
Software	Software verification and validation per FDA guidance; Classified as Class B (IEC 62304:2006);
Software level of concern: "Moderate"; Cybersecurity risk assessment and mitigation.	All tests conducted, documentation provided demonstrating compliance with FDA guidance and industry standards. Cybersecurity risks assessed and mitigated.
EMC and Electrical Safety	IEC 60601-1-2:2014; IEC 60601-1:2005+CORR 1:2006+CORR 2:2007+A1:2012; IEC 60601-2-18:2009	Acceptable level of electromagnetic compatibility (EMC) and electrical safety (ES) confirmed according to stated standards.
Optical Testing	Signal to noise, color, limiting spatial resolution transfer function (MTF), distortion, light distribution, spectral distribution, total luminous flux and photobiological safety (tested for EB15-J10 and EB19-J10 with EPK-3000, EPK-i7010, EPK-i5010 Video Processors).	All results show that the optical characteristics of the subject device are equivalent to those of the predicate device.
Clinical Image Capture	Visualization of vascularity and mucosal surface for each anatomical area.	Subject device demonstrates equivalent or better capabilities in visualization compared to the predicate device.

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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