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XEROSTOM® has been formulated to the relief of dry mouth symptoms such as difficulties in swallowing, speech, changes in taste, mouth discomfort, and other symptoms associated with dry mouth. These symptoms may be brought on by disease, stress, aging or medication.

XEROSTOM® may be used to replace normal salivary glands are damaged or not functioning.

XEROSTOM® relieves the problems of dry mouth.

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The provided text is a 510(k) clearance letter from the FDA for a device named "Xerostom® Saliva Substitute Gel." This document is a regulatory communication, not a study report. As such, it does not contain the acceptance criteria or details of a study demonstrating the device's performance against acceptance criteria.

The letter confirms that the device has been found substantially equivalent to legally marketed predicate devices, primarily based on its stated Indications for Use. It does not provide data from clinical trials, performance studies, or details about ground truth, expert adjudication, or sample sizes typically found in a study report for an AI/ML or diagnostic device.

Therefore, I cannot provide the requested information based on the text provided.

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