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The PORTEX® Adjustable Flange Tracheostomy Tube is indicated for airway management of tracheostomized patients where the ability to adjust the depth of insertion may be advantageous.

The PORTEX® Adjustable Flange Tracheostomy Tubes are made of implant tested, polyvinyl chloride with compatible profile, high volume, low pressure cuff. Radiopaque material is incorporated into the full length of the Adjustable Flange Tracheostomy Tube. The trachesstomy tube has an adjustable neck flange and a bonded 15 mm connector. The cuff inflation line has an inflation indicator and a self sealing luer one-way valve.

This document does not describe acceptance criteria for a device, nor a study performed to prove a device meets acceptance criteria. Instead, it is a 510(k) summary for the PORTEX® Adjustable Flange Tracheostomy Tube, a medical device.

The section titled "SUMMARY OF PERFORMANCE DATA" explicitly states: "Performance assessment was not required to demonstrate substantial equivalence of the proposed device to the predicate devices."

Therefore, I cannot provide the requested information. The document indicates that no formal performance acceptance criteria or a study designed to prove the device met such criteria were necessary for this 510(k) submission, as the device was deemed substantially equivalent to predicate devices.

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