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The Fluid-filled Teether is indicated to help to relieve the teething discomfort of teething infants by providing a cool soothing effect.

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The provided text describes a 510(k) premarket notification for a "Fluid-Filled Teether" (K092910). This document is a regulatory approval letter and does not contain information about acceptance criteria, study methodologies, or performance data as typically provided for medical devices that undergo rigorous clinical or technical validation.

The "Fluid-Filled Teether" is a Class II device (Teething Ring, Product Code: KKO), which falls under general controls and potentially special controls, but the specifics of those controls or any performance studies are not detailed in this letter. The letter simply states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information. The document focuses solely on the regulatory approval for marketing the device based on substantial equivalence, not on a detailed performance study with acceptance criteria and results.

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