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Designed to provide transtracheal ventilation in specific emergency situations of upper airway obstruction, used in conjunction with a transtracheal catheter, or a cricothyrotomy needle, which is inserted through the cricothyroid membrane. Ventilation is accomplished by manual, intermittent jetting of oxygen through the catheter for subsequent lung inflation.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called "Manujet III Manual Jet Ventilator." This letter signifies that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the detailed technical study information that would be necessary to answer your request. This type of information is typically found in the 510(k) submission itself, which is not publicly available in this FDA decision letter.

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

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