(209 days)
Provide tracheal access for airway management and subglottic secretion management in adult patients. It is also intended for use with percutaneous dilatational tracheotomy (PDT) procedures.
The subject device is a single patient use tracheostomy tube that features an outer cannula with a radiopaque line alonq its length and a standard 15mm connector for direct connection to standard ventilation and anesthesia equipment. It has an integrated evac suction line in the outer cannula for suctioning of subqlottic secretions that may pool above the cuff. It is available in three configurations: single cannula (no inner cannula), disposable inner cannula (DIC) and single patient use reusable inner cannula (RIC).
It appears there may be a misunderstanding. The document provided is an FDA 510(k) clearance letter and associated summary for a medical device (tracheostomy tube), not a study proving an AI/software device meets acceptance criteria.
The document details the equivalence of a new tracheostomy tube (Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff) to previously cleared predicate devices, based on similar technological characteristics, intended use, and performance data from bench testing, biocompatibility, sterilization, and human factors. It does not involve AI or software, and therefore, it does not contain the information you requested about acceptance criteria and a study proving an AI device's performance.
To answer your request, I would need a document describing an AI/software medical device's performance study, including its acceptance criteria and the results of that study.
The document you provided is about a conventional medical device.
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.