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The device is designed as single use, sterile, uncuffed tracheal tube for oral or nasal tracheal intubation and indicated for airway management.

The device, which is equivalent to other devices currently being marketed, consists of a clear P.V.C. tube with an encapsulated stainless steel reinforcing spiral. The tube is graduated with multiple centimeter markings to allow easy determination of the intubated length, and is terminated with a fully inserted connector.

I am sorry, but the provided text from the regulatory submission K954585 for the "Rüsch Pediatric Reinforced Tracheal Tube - Uncuffed, sterile" does not contain the information requested regarding acceptance criteria or a study proving the device meets acceptance criteria.

This document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to predicate devices already on the market. It explains that the new device is substantially equivalent in design, use, and materials to existing devices and therefore no difference in safety and effectiveness is forecasted.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, or specific studies.
3. Information about expert involvement or ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Information on training sets or their ground truth.

Therefore, I cannot fulfill your request based on the provided text.

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