(219 days)
The flexible bronchoscope have been designed to be used with the video 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 Flexible Bronchoscope is a single-use device designed for use in adults.
The Bronchoscope System consists of Flexible Bronchoscope (twelve models shown in below) to be introduced within the airways or tracheobronchial tree and Video Processor (model: EOS-H-01) for clinical image processing. The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Video Processor provides power and processes the images for medical electronic endoscope.
The Flexible Bronchoscope is a sterile single used flexible bronchoscope. The Video Processor is a reusable monitor.
The light emitted by the LED cold light source at the distal tip of the disposable video 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 Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LEDs on the endoscope.
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria from an AI/ML perspective. The document is a 510(k) summary for a Bronchoscope System, which is a medical device, but it does not describe an AI/ML-driven diagnostic or assistive technology.
The "Performance Data" section details various engineering and biological tests conducted for the Bronchoscope System, such as biocompatibility, sterilization, electrical safety, EMC, software verification, and bench performance testing. These tests ensure the device's physical and functional safety and effectiveness, but they do not involve AI/ML performance metrics like sensitivity, specificity, or AUC against a ground truth.
Specifically, there is no mention of the following in the provided text:
- A table of acceptance criteria and reported device performance for an AI/ML component.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or ground truth type related to an AI/ML model for a test set.
- Sample size or ground truth establishment for a training set of an AI/ML model.
The document explicitly states under "Clinical Testing": "Based on the similarities of the device specifications, intended use, indications for use between the Bronchoscope System and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification." This further confirms that no studies involving human interpretation augmented or replaced by AI, or studies evaluating AI performance metrics, were part of this submission.
Therefore, I cannot fulfill your request for information related to AI/ML acceptance criteria and study data from this document.
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.