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• 1. To establish a patent airway to provide ventilation to a patient who has undergone cardiac* and/or pulmonary arrest.
• 2. To establish a protected airway where a compromised or obstructed airway exists in an unconscious patient. *
• To establish a patent airway in a conscious patient who is unable to ventilate 3. adequately. *
• 4. To establish a patent airway where a rescuer is unable to ventilate the unconscious patient with conventional methods. *
• 5. This device is particularly indicated where standard tracheal tube intubation may be difficult or not possible.
• 6. Where either tracheal or esophageal obturator airway is indicated.
• 7. Applicable to larger children, small adult or adult depending on sizes of our product available, with applied clinical judgement required.
• 8. For use by a person trained and experienced in airway management and the use of this device.

FastTrach Single-Pass Trachea1/Esophagea1 Airway System

I am sorry, but the provided text is a 510(k) clearance letter for the FastTrach™ Single-Pass Tracheal/Esophageal Airway System. It states that the device is substantially equivalent to legally marketed predicate devices.

This document does NOT contain information regarding:

• Acceptance criteria or reported device performance metrics.
• A clinical study design, sample sizes, data provenance, expert qualifications, or adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
• The type or establishment of ground truth for training or test sets.

Therefore, I cannot extract the requested information from the provided text.

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