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Tracheal tube designed for oral and nasal intubation and indicated for airway management.

Sterile, single-use device for use in anesthesia and emergent and respiratory care. Center-beveled, flexible, curved, slightly rounded, tapered distal tip. Curved and preformed (shaped) tube configurations. Two facing Murphy eyes flanking the bevel. Polyvinyl chloride material with a barium sulfate filled stripe along the length of the device.

The provided text does not contain information about acceptance criteria, device performance metrics, or a detailed study proving the device meets specific criteria. The document is a 510(k) summary and an FDA clearance letter for a medical device (Parker Flex-Tip Tracheal Tube), which focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance study results against defined acceptance criteria.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor the detailed information about sample sizes, ground truth establishment, or multi-reader studies.

The "Test Data" section in the 510(k) Summary states: "Independent clinical testing of the Parker Flex-Tip Tracheal Tube demonstrates that it significantly minimizes and prevents the nasal trauma and bleeding which commonly occur in nasal intubations performed with comparable, commercially available tracheal tubes." However, this is a summary statement and does not provide the specific details required to answer your questions.

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