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The Single-use Bronchoscope have been designed to be used with the Image Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Bronchoscope System is for use in a hospital environment. The Single-use is a single-use device designed for use in adults.

The Bronchoscope System consists of Single-use Bronchoscope (six models shown in below) to be introduced within the airways or tracheobronchial tree and Image Processor (model: VLM-02) for clinical image processing. The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Image Processor provides power and processes the images for medical electronic endoscope.

The Single-use Bronchoscope is a sterile single used flexible bronchoscope. The Image Processor is a reusable monitor.

The light emitted by the LED cold light source at the distal tip of the Single-use Bronchoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Image Processor via the VI circuit. The Image Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the monitor. The Image Processor also controls the brightness of the LEDs on the endoscope.

The optical components and their arrangement at the distal tip for all models of the Singleuse Bronchoscope are identical.

Single-use Bronchoscope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera and LED light source at the distal tip
• Sterilized by Ethylene Oxide
• For single use

Image Processor has the following physical and performance characteristics:

• Display the image from the Single-use Bronchoscope on the screen ●
• Can record screenshots or video of image from the Single-use Bronchoscope
• Can connect to an external monitor ●
• Reusable device

The provided text is a 510(k) summary for a Bronchoscope System. It details the device description, indications for use, comparison to a predicate device, and performance data. However, it does not contain information about an AI/ML-based device or a study involving human readers and AI assistance.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device. The document lists bench performance tests according to ISO 8600 series and other parameters, but these are for a standard bronchoscope system, not an AI component.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML component.
• Sample size for the training set for an AI/ML component.
• How ground truth for the training set was established for an AI/ML component.

The document explicitly states: "No clinical study is included in this submission" (Section 10), and the performance data primarily relates to bench testing, biocompatibility, sterilization, electrical safety, and software verification/validation for the traditional bronchoscope system.

To answer your request for an AI/ML device, I would need a different document that describes such a device and its associated clinical or performance studies.

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