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CLEARADEX GEL is a space-occupying gel is intended for use by a medical professional:

• to control minimal bleeding following ENT surgery
• to separate and prevent adhesions between mucosal surfaces in the nasal cavity
• as an adjunct to aid in the natural healing process during the postoperative period

CLEARADEX GEL is a space-occupying gel

This document is an FDA 510(k) clearance letter for a medical device called "Clearadex Gel". It does not describe a study that proves the device meets acceptance criteria, nor does it provide performance data, sample sizes, expert qualifications, or details about AI assistance.

The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, the information requested in your prompt regarding acceptance criteria, study details, and performance data for this specific device is not available in the provided text. The FDA's 510(k) clearance process relies on demonstrating substantial equivalence to a predicate device, rather than requiring a detailed study proving the new device meets specific quantitative acceptance criteria in the manner you've outlined.

The "Indications for Use" section (Image/page/2/Picture/0) describes what the device is intended for, but these are not acceptance criteria in the form of performance metrics.

In summary, the provided document does not contain the information required to answer your questions about acceptance criteria and study details.

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