Search Results

The Venner PneuxP. Y.TM Tracheostomy Tube (TT) is a tracheostomy tube intended to be inserted into the patient's trachea via a tracheostomy stoma during extended periods (not more than 30 days) of intensive or critical care to facilitate ventiliation and for evacuation or drainage of secretion from the subglottice space.

Venner Pneux P.Y.TM TracheostomyTube

I am sorry, but the provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a medical device (Venner Pneux P.Y. Tracheostomy Tube). This document primarily focuses on the regulatory approval process and includes information such as the device name, regulation number, regulatory class, and the FDA's determination of substantial equivalence to predicate devices.

It does not contain information about acceptance criteria, specific device performance data from a study, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details about multi-reader multi-case studies or standalone algorithm performance.

Therefore, I cannot fulfill your request for a description of the acceptance criteria and the study that proves the device meets them based on the provided text.

Ask a specific question about this device

The Venner PneuxP.Y.TM EndoTracheal Tube (ETT) is an endotracheal tube intended to be used for patients undergoing tracheal tube intubation during extended periods (not more than 30 deays) and for evacuation or drainage of secretion from the subglottice space. It is also compatible with tracheal intubation during routine anesthesia.

Not Found

I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria. The document is a 510(k) clearance letter from the FDA for the "Venner Pneux P. Y. EndoTracheal Tube." It primarily discusses the regulatory approval process, the device's classification, and general compliance requirements, but it does not detail any specific acceptance criteria for performance or a study demonstrating the device meets such criteria.

Ask a specific question about this device