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The intended purpose of the fluid filled teether is to relieve the teething discomfort of infants by giving cool soothing effect when the cool teether is chewed on.

Fluid Filled Teether

This document is a 510(k) clearance letter from the FDA for a "Fluid Filled Teether." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested details based on the provided text. The document confirms that the device is cleared for market due to substantial equivalence, but it does not describe the specific testing or studies that would demonstrate its performance against acceptance criteria.

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