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The intended use of the fluid filled teether is to help to relieve the teething discomfort of teething. infants by providing a cool soothing effect. The Global Fluid Filled Teether is intended for over-the-counter use.

Fluid Filled Teether

This document is a 510(k) submission for a fluid-filled teether, which is a medical device. However, this document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

The provided text is a summary of the 510(k) submission, primarily focusing on the administrative details, intended use, and substantial equivalence determination by the FDA. It states that the Global Fluid Filled Teether is substantially equivalent to a previously cleared device (K031094). Substantial equivalence means that the new device is as safe and effective as a legally marketed predicate device, and does not require extensive clinical trials or performance studies if the technological characteristics are similar and the intended use is the same.

Therefore, I cannot provide the requested information based on the input text. The information typically requested (such as sample sizes, ground truth, expert qualifications, efficacy studies, etc.) is more relevant for novel or high-risk devices that require more rigorous performance testing and clinical data. For a device like a teether seeking substantial equivalence, such detailed performance studies as those outlined in your request are generally not required for the 510(k) pathway.

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