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TheraBreath Dry Mouth Oral Rinse is intended for relief of dry mouth symptoms and is indicated for use to refresh, moisturize, lubricate and soothe the oral cavity, and alleviate discomfort due to dry mouth.

TheraBreath Dry Mouth Lozenges are intended for relief of dry mouth symptoms, and are indicated for use to refresh, moisturize, lubricated, and soothe the oral cavity, and alleviate discomfort due to dry mouth.

TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges are specifically formulated as an artificial saliva substitute with moisturizers, humectants and salivary enzymes with lubricating, moisturizing and soothing properties to relieve the symptoms of dry mouth. In addition. TheraBreath Dry Mouth Lozenges continuously moisten the mouth to relieve the symptoms of Dry Mouth and to refresh breath. TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges are sugar-free, alcohol-free, and gluten-free.

TheraBreath Dry Mouth Oral Rinse is packaged in 16 ounce size bottles and is Tingling Mint flavored. TheraBreath Dry Mouth Lozenges are Mandarin Mint flavored and are sold in boxes of 24, 72, or 100 lozenges.

The provided text is a 510(k) summary for medical devices (TheraBreath Dry Mouth Oral Rinse and TheraBreath Dry Mouth Lozenges), seeking to establish substantial equivalence to predicate devices. This document does not contain information about an AI/ML medical device, nor does it describe acceptance criteria and a study proving a device meets those criteria for such a device.

Instead, it's a submission for an over-the-counter dry mouth relief product. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical tests (biocompatibility, shelf-life, physical properties) to demonstrate the safety and performance of the new products are comparable to existing, legally marketed products.

Therefore, I cannot fulfill your request for detailed information about an AI/ML device's acceptance criteria and studies based on the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes, data provenance, expert numbers/qualifications, or adjudication methods for an AI/ML test set.
• MRMC comparative effectiveness studies or standalone AI algorithm performance.
• Methods for establishing ground truth for training or test sets in an AI/ML context.

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