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The Single-Use Video Bronchoscopes have been designed to be used with the Digital Controller, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Single-Use Video Bronchoscope is only designed for use in hospitals.

The Single-Use Video Bronchoscope is a disposable medical device for use on adults.

The Digital Controller can be used in conjunction with Micro-Tech scope products to provide illumination brightness adjustment ability and receive, process and output images from them for endoscopy.

The Video Bronchoscope System consists of:

Single-Use Video Bronchoscope:

• SVB11001
• SVB22001
• SVB33001

Digital Controller:

• DC00001
  The Single-Use Video Bronchoscopes are all sterile single use flexible bronchoscope and Digital Controller is a reusable device.

The Single-Use Video Bronchoscopes have the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Flexible insertion cord
• Working channel
• Camera and LED light source at the distal tip.

The light emitted by the LED cold light source of the Single-Use Video Bronchoscopes lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS. The CMOS acquisition image is controlled by the circuit, and the standard color video signal is output to the digital video processor via the encoding circuit. The digital video processor adjusts the brightness of the light source and outputs the standard color video signal. The imaging sensor pixel count is 400× 400 and the pixel size is 1.75 µm × 1.75 µm.

The optical components and their arrangement at the distal tip for all models of Single-Use Video Bronchoscopes are identical.

The Single-Use Video Bronchoscopes have different size as follows:

• Maximum insertion portion width
• Deflection angle
• Minimum instrument channel width

The Digital Controller has the following physical and performance characteristics:

• Displays the image from The Single-Use Video Bronchoscope on the screen
• Can record screenshots or video of image from the Single-Use Video Bronchoscope
• Can connect to an external monitor
• Reusable device

The provided document is an FDA 510(k) summary for a medical device called the "Video Bronchoscope System." It primarily focuses on demonstrating substantial equivalence to a predicate device (Ambu® aScope™ 3, Ambu® aView™ Monitor K173727) through various performance tests, but it does not contain information about acceptance criteria for an AI/algorithm, a study proving an AI/algorithm meets acceptance criteria, or any details related to human reader studies or ground truth establishment relevant to AI development.

The document states:

• "No animal study is included in this submission."
• "No clinical study is included in this submission."

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and a study that proves a device meets acceptance criteria for an AI/algorithm. The document describes various engineering and performance tests for hardware components of a bronchoscope system (e.g., dimension, deflection angle, optical tests, biocompatibility, electrical performance, shelf-life, sterilization) to establish substantial equivalence to a predicate device, but not for an AI/algorithm.

The questions in your prompt are geared towards evaluating an AI/Machine Learning medical device, which is not what this FDA submission describes.

If you have a different document that details an AI/algorithm's performance and validation, please provide that.

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