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Rüsch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.

The Rusch Reinforced Endotracheal Tube consists of a specially designed, clear PVC tube with stainless steel reinforcing spiral. The tube is graduated with multiple centimeter markings to allow easy determination of intubation length, and is terminated with a connector. An optional Murphy eye provides an alternative opening. This eye is the difference between the Murphy (with eye) and the Magill (without eye) tracheal tube. The device is for nasal/oral use. The Rusch Reinforced Endotracheal tube, cuffed is fitted with a cuff, which is inflated through an inflation line and a lumen in the wall of the tube.

The provided text is a 510(k) summary for the Rusch Reinforced Endotracheal Tube. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment for AI/ML device validation.

The document details:

• Submitter Information: Rusch International, Karenann J. Brozowski.
• Device Identification: Rusch Reinforced Endotracheal Tube, Cuffed and Uncuffed, of Murphy/Magill, sterile.
• Classification: Tube, Tracheal (with/without connector).
• Predicate Devices: Willy Rüsch Reinforced Tracheal Tube, Sheridan Reinforced Cuffed Tracheal Tube, SIMS/Portex Reinforced Cuffed Silicone Tracheal Tube, and NCC/Mallinckrodt Reinforced Tracheal Tube Cuffed.
• Device Description: Clear PVC tube with stainless steel reinforcing spiral, graduated markings, connector, optional Murphy eye, cuffed version with inflation line.
• Intended Use: Oral or nasal intubation for airway management, to reduce kinking when unusual head/neck positioning is required.
• Technological Characteristics: Equivalent design and intended use to predicate devices, spiral PVC tubes, cuffed/uncuffed, with or without luer activated valve.
• FDA Clearance Letter: Confirms substantial equivalence to predicate devices and clearance to market.

Therefore, I cannot provide the requested information about acceptance criteria and device performance studies as it is not present in the given text.

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