(259 days)
Rota-Trach Disposable Standard Tracheostomy Tube is indicated for airway maintenance of tracheostomized patients.
Rota-Trach Disposable Standard Tracheostomy Tube is a respiratory device inserted into the patient's trachea through a stoma, making direct contact with the tracheal mucosal membrane tissue. It may be with or without a cuff attaching around the tube of the device. The design of the cuff could seal the space between the tube and the patient's trachea from inhaling undesired or foreign matters and for assistance of positive pressure ventilation.
The provided document is a 510(k) clearance letter and summary for a physical medical device (tracheostomy tube), not a software-based AI/ML device. Therefore, the document does not contain information about acceptance criteria or studies proving performance for an AI/ML device.
The questions asked pertain specifically to the validation of AI/ML models in medical devices, which typically involve metrics like accuracy, sensitivity, specificity, and detailed study designs (test sets, ground truth, expert adjudication, MRMC studies, etc.).
Since the document describes a Class II physical medical device (Tracheostomy Tube and Tube Cuff), the information regarding acceptance criteria and performance data is related to its physical and biological safety and efficacy, not AI/ML performance.
Therefore, I cannot provide the requested information because the provided input does not describe an AI/ML device or its validation.
§ 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.