(473 days)
The Pulmonary Cytology Brush is intended to allow brush sampling of tissue or cells from the upper or lower respiratory tract and/or to perform surveillance cultures
Not Found
This document is a 510(k) Premarket Notification decision letter from the FDA for a device named "Pulmonary Cytology Brush." It explains that the device has been found substantially equivalent to a legally marketed predicate device.
Crucially, this document is NOT a study report for an AI/ML medical device. It does not contain any information about acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes, expert qualifications, ground truth establishment, or any of the other details typically found in a clinical study report for an AI device.
The Pulmonary Cytology Brush is a physical medical instrument used for sampling tissue/cells, not an AI/ML algorithm that requires performance studies measuring its diagnostic or prognostic accuracy. Therefore, the requested information (acceptance criteria, study details, human reader performance, training set details) is not applicable to this document.
To answer your request, I would need a different type of document, specifically a clinical study report or a 510(k) submission summary for an AI/ML-based medical device.
§ 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.