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The biotene Oral Balance Gel, biotene Dry Mouth Oral Rinse and biotene Moisturizing Mouth Spray intended use is to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation and lubricate oral dryness.

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This document is a 510(k) clearance letter from the FDA for Biotene Oral Balance Gel, Biotene Dry Mouth Oral Rinse, and Biotene Moisturizing Mouth Spray. It states that these devices are substantially equivalent to legally marketed predicate devices.

The information requested in the prompt regarding acceptance criteria and a study proving the device meets these criteria is typically found in the 510(k) submission itself, or in supporting documentation attached to the submission. This FDA clearance letter and its attached "Indications for Use Statement" do not contain the detailed information necessary to answer the questions about acceptance criteria, device performance, study design, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The document confirms the device names and their intended use to relieve symptoms of dry mouth. However, it does not provide any specific quantitative performance metrics, study results, or details on how substantial equivalence was demonstrated beyond the general statement of equivalence to predicate devices.

Therefore, I cannot provide the requested table or answer the specific questions based solely on the provided text.

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