Search Results

The intended use or purpose of the Device is to provide a teething child with a cool soothing effect on the gums when the Device is chewed upon.

Not Found

This document is a 510(k) premarket notification approval letter from the FDA for a device described as "Water Filled Gum Soother" and "Teething Ring - Water Filled." It is an approval letter for marketing the device based on substantial equivalence to a legally marketed predicate device, not a study. Therefore, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The provided text does not contain any data related to device performance studies or acceptance criteria. It is an FDA clearance letter for a medical device ("Water Filled Gum Soother" / "Teething Ring - Water Filled") based on substantial equivalence.

Therefore, I cannot provide the requested information.

Ask a specific question about this device