(142 days)
The device use is the treatment of hemorrhoids by applying it directly to the swollen Hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The cap section is used for the treatment of external hemorrhoids and the tube section for the treatment of internal hemorrhoids. The lubricant is used to ease the introduction of the tube into the rectum.
Not Found
The provided text is an FDA 510(k) clearance letter for a device called "anucure," which is intended for the treatment of hemorrhoids by applying cold to the tissue.
This document does not contain any information regarding acceptance criteria, device performance, study design, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory approval letter based on substantial equivalence to predicate devices, not a study report.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based solely on the provided text.
N/A