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ENDOCERVICAL CYTOLOGICAL CELL COLLECTOR BRUSH FOR PAP SMEAR.

ORIBRUSH - WITH PROTECTIVE TIP - B001

This document is a 510(k) clearance letter from the FDA for a medical device called "ORIBRUSH Cervical Brush Model B001 with protective tip." It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. The document is purely an administrative letter granting market clearance based on substantial equivalence, not a detailed report of device performance testing.

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

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