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The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment.

This Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.

This Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor (HDVS-S100A and HDVS-S100D) to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.

The proposed device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and an Endoscopic Image Processor including the foot switch. The proposed device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi and lungs.

The Single-use Broncho Videoscope is a single use device. The Single-use Broncho Videoscope has six models which are available in three kinds of outer diameter of insertion (Φ2.8mm, Φ4.2mm and Φ5.6mm), one working length (600mm) and two different material of the insertion (Nylon and PEEK). The single-use Broncho Videoscope is a single-channel endoscope. Only one working channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section.

The Single-use Broncho Videoscope is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.

Here's a breakdown of the requested information based on the provided text, outlining the acceptance criteria and study details for the Broncho Videoscope System:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are broad, based on compliance with various international standards and demonstrating equivalence to a predicate device. The performance is reported as meeting these standards and being comparable to or better than the predicate.

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

• Test Set Sample Size: Not explicitly stated as a number of devices or "cases" for human studies. The testing appears to be primarily bench/laboratory-based on the device components. For the use-life testing, "un-aged" and "aged" single-use bronchoscopes were compared, and "new" and "accelerated aged and running" image processors were compared, implying at least two samples for these comparisons.
• Data Provenance: The studies are non-clinical (bench performance, testing against standards). The country of origin for the data is not specified, but the applicant is "Scivita Medical Technology Co., Ltd." in "Suzhou, Jiangsu, China," suggesting the testing may have occurred there. The studies are prospective in nature, as they are conducted specifically to support this 510(k) submission.

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

Not applicable for this submission. The ground truth for the non-clinical tests is established by compliance with international standards and direct objective measurements, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical submission relying on objective measurements against predefined standards and comparative bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission."

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

• Yes, a standalone performance assessment was conducted for the device itself. The entire non-clinical testing section (bench performance, biocompatibility, electrical safety, etc.) is a standalone assessment of the device's technical specifications and performance against established standards and a predicate device. This is primarily a hardware device with associated software, not an AI algorithm in the typical sense that would necessitate a "human-in-the-loop" study for algorithm performance.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests includes:

• International Standards: Compliance with various ISO, ASTM, and IEC standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, ISO 8600 for endoscope performance).
• Predicate Device Performance: Direct comparison of objective measurements (e.g., optical parameters, suction function) against a legally marketed predicate device (Vathin Video Bronchoscope System K191828).
• Objective Measurements: Laboratory measurements of device specifications (e.g., field of view, depth of field, dimensions, weight, power).

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning or AI algorithm in the common sense that would require a "training set" of data for learning purposes. The "software" mentioned is for device control and image processing, not for diagnostic AI interpretation.

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

Not applicable, as there is no "training set."

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