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The SULLIVAN VPAP II ST-A System is intended to assist the ventilation of spontaneously breathing adult patients with respiratory insufficiency and/or obstructive sleep apnea. The patient is expected to have no more than minor and transient adverse effects if ventilation is not provided for extensive periods, for example overnight. The System is intended for patients who have adequate mental and physical capabilities, allowing them to quickly remove the mask in the case of system failure. The system is intended for use in the hospital or home.

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The provided text is a 510(k) clearance letter from the FDA for a device called "SULLIVAN® VPAP II ST-A Nasal VPAP System". This type of document declares the device substantially equivalent to a predicate device, allowing it to be marketed.

However, a 510(k) clearance letter does not typically contain acceptance criteria or study results detailing device performance related to specific metrics like sensitivity, specificity, accuracy, etc. It focuses on establishing substantial equivalence based on indications for use and technological characteristics, often referencing data and information provided in the original 510(k) submission, which is not included in this document.

Therefore, based solely on the provided text, I cannot fill in the table or answer most of the questions about acceptance criteria and a study proving device performance because that information is not present. The document is an FDA approval letter, not a study report.

I can, however, extract the following relevant information:

• Device Name: SULLIVAN® VPAP II ST-A Nasal VPAP System
• Intended Use: "The SULLIVAN VPAP II ST-A System is intended to assist the ventilation of spontaneously breathing adult patients with respiratory insufficiency and/or obstructive sleep apnea. The patient is expected to have no more than minor and transient adverse effects if ventilation is not provided for extensive periods, for example overnight. The System is intended for patients who have adequate mental and physical capabilities, allowing them to quickly remove the mask in the case of system failure. The system is intended for use in the hospital or home."
• Regulatory Class: II (two)
• Product Code: 73 MNS

Without the actual 510(k) submission (which would contain the performance data), the requested information cannot be provided.

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