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FUJIFILM Bronchoscopes EB-580S and EB-580T are intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

FUJIFILM Bronchoscopes EB-580S and EB-580T are comprised of three general sections: a control portion, an insertion portion and an umbilicus. The control the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a charge-coupled device (CCD) image sensor in its distal end. The channels in the insertion portion assist in delivering suction as well as endoscope accessories, such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CCD image sensor to capture an image and display it on the monitor. The umbilicus consists of electronic components needed to operate the endoscope when plugged into the video processor and light source. The endoscopes are used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart. All of these combinations were previously cleared in K122535.

EB-580S and EB-580T can be used with Video Processor VP-7000 and Light Source BL-7000. However, LCI, FICE, and BLI imaging modes are not compatible with the subject devices.

This document describes the performance testing for the FUJIFILM Bronchoscopes EB-580S and EB-580T.

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 specific sample sizes used for each individual test (e.g., number of units tested for electrical safety, biocompatibility, or endoscope-specific metrics). However, the performance data presented is based on bench testing. This indicates that the data provenance is from prospective testing conducted by the manufacturer, likely in a controlled laboratory environment. The country of origin of the data is not specified directly for the testing, but the submitter is FUJIFILM Corporation, located in Japan.

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

The document does not mention the involvement of experts to establish a "ground truth" for the performance testing. The evaluation appears to be based on adherence to established consensus standards and the manufacturer's internal performance specifications. For device performance in terms of physical and electrical characteristics, the "ground truth" is typically defined by the technical specifications outlined in the standards themselves or by engineering design specifications, rather than by expert clinical interpretation.

4. Adjudication Method for the Test Set

No adjudication method is described, as the testing involves objective measurement against engineering standards and specifications rather than subjective interpretation by multiple human assessors.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study was mentioned. The submission is for a medical device (bronchoscope) and focuses on its compliance with safety and performance standards, not on evaluating the improvement of human readers with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device described is a physical medical instrument (bronchoscope), not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance testing was based on:

• Consensus Standards: International and national standards for electrical safety (e.g., IEC 60601 series), biocompatibility (e.g., ISO 10993 series), endoscope specifics (e.g., ISO 8600 series), and reprocessing (e.g., AAMI TIR series).
• Manufacturer's Performance Specifications: Internal design and functional requirements for physical parameters like field of view, working length, bending capability, resolution, etc.

8. The Sample Size for the Training Set

This section is not applicable. The document describes a physical medical device (bronchoscope), not a system involving a training set for an algorithm.

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

This section is not applicable for the same reason as above.

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