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The Sinus Irrigation / Suction Handle and the accompanying sheath are used to provide a means for rities mass frightin - Subtron - Subtity, a means of suction from the same cavity and a holder for a 4.0mm telescope to view the sinus cavity.

The Sinus Irrigation / Suction Handle can be used in conjunction with laser procedures and may be used with warm (heated) irrigation solutions. One such procedure is the VideoHydrascopic technique developed by Daniel Schuman. MD

The irrigation / suction handle with sheath allows the insertion of a 4 0mm telescope and provides the physician the ability to view, apply irrigation fluids, and suction the cavity.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, or any of the other requested details regarding a medical device. The document is a 510(k) Summary for an "Irrigation/Suction Handle with sheath" from 1996, and it explicitly states:

• "No performance data was obtained."
• "No clinical tests were performed."

The document focuses on establishing substantial equivalence to previously marketed devices based on technological characteristics and intended use, rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, I cannot populate the requested table or answer any of the questions about a study showing the device meets acceptance criteria.

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