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Relieves the symptoms of dry mouth, while moisturizing and lubricating oral dryness.

Moisyn is a specifically formulated artificial saliva substitute which contains moisturizers, humectants, and biopolymers that are designed to relieve dry mouth symptoms, soothe irritated oral surfaces, refresh, clean, and lubricate. The rinse is supplied as an 80z PET bottle or as a 20z PET spray bottle. Both bottles contain the same solution without any changes in formulation or intended use. Both the rinse and the Mist are formulated with and without spearmint flavor to provide the customer with a choice in flavoring.

The provided text is a 510(k) summary for the device "Moisyn Dry Mouth Oral Rinse/Mist". It describes the device, its intended use, comparison with predicate devices, and performance data. However, the information requested regarding acceptance criteria and a study proving the device meets these criteria (especially related to AI/algorithm performance, expert review, MRMC studies, etc.) is not present in this document.

This document is a regulatory submission for a medical device that relieves symptoms of dry mouth. It focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, technological characteristics, and safety aspects (biocompatibility, preservation effectiveness, shelf-life, viral inactivation).

Here's a breakdown of why the requested information cannot be extracted:

• No AI/Algorithm Component: The device described is a physical oral rinse/mist, not an AI or algorithm-driven diagnostic or medical imaging device. Therefore, concepts like acceptance criteria for AI performance (sensitivity, specificity, AUC), test sets, training sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance are not applicable.
• Performance Data Focus: The "Performance data" section refers to standard biocompatibility testing, preservative effectiveness, and shelf-life, which are relevant for a chemical/physical product, not an AI.
• "Clinical Study" Context: The mention of a "Clinical Study" refers to a human study evaluating the effectiveness of the oral rinse in relieving dry mouth symptoms, not the performance of an AI or diagnostic algorithm. The study cited is about symptom improvement and saliva production, not diagnostic accuracy.

Therefore, I cannot provide a table of acceptance criteria for AI performance or details about an AI-related study because the device in question is not an AI/algorithm.

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