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-User is asked to wash teethers in warm, soapy water, rinse clean, and then to chill them in refrigerator -teether then acts as a cold compress for baby's gums and helps reduce the discomfort of teething

Water Filled Teether

This document is a 510(k) premarket notification letter from the FDA for a "Baby Snoopy Water Filled Teether". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the type of information requested about acceptance criteria, study details, sample sizes, ground truth, or multi-reader multi-case studies, which are typically associated with performance evaluations of AI/ML-enabled medical devices or diagnostic tools.

The letter is a regulatory approval based on demonstrating substantial equivalence, not a performance study of a device against specific acceptance criteria in the way your prompt describes. The device is a "teething ring," a simple consumer product, not a complex diagnostic or therapeutic device requiring extensive clinical performance studies.

Therefore, I cannot extract the requested information from this document.

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