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The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.

The Frontal Sinus Spacer is a device that maintains an opening at the frontal sinus for up to 14 days postoperatively. The subject device can be manually removed during an office follow-up visit at any time.

The provided document is a 510(k) summary for the Acclarent Relieva Stratus MicroFlow Spacer. However, it does not contain the detailed performance data or study information required to answer your specific questions about acceptance criteria and study design.

The document states:

• "The Frontal Sinus Spacer met all performance acceptance criteria."
• "The Frontal Sinus Spacer is substantially equivalent to the predicate device as confirmed through relevant performance tests."

This indicates that internal performance testing was conducted, and the device met the pre-defined criteria. However, the summary does not provide the actual acceptance criteria, the reported device performance metrics, or any details about the study design (e.g., sample size, ground truth, expert qualifications, adjudication methods, or a multi-reader multi-case comparative effectiveness study).

Therefore, I cannot populate the table or provide specific answers to questions 2 through 9 based solely on the provided text. To get that information, you would typically need to consult a more detailed document, such as the full 510(k) submission or a dedicated performance study report, which are not included here.

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