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Provides relief of the symptoms and discomfort of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation and lubricates oral dryness. Freshens breath.

SmartMouth® DryMouth Oral Rinse is a specially formulated water soluble artificial saliva with for use at home in the oral cavity. It is formulated with water, humectants/moisturizers, including two moisture-rich humectants that are plant based, thickeners/binders, buffers, sweeteners, flavor, and colorant that collectively have moisturizing, soothing, and refreshing properties. The device is provided ready to use as a non-sterile, two-part semi-viscous green colored liquid packaged in white polyethylene terephthalate (PET) bottles with a clear polypropylene cap that present the liquid out of the polypropylene spout.

The provided document is a 510(k) summary for the SmartMouth® DryMouth Oral Rinse. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through extensive clinical studies like those for novel high-risk devices.

Therefore, the sections of your request regarding acceptance criteria, study details, expert involvement, and ground truth are not applicable to this document, as it describes a clearance process for a low-risk, unclassified device based on substantial equivalence.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: For this 510(k) submission, the primary "acceptance criteria" is demonstrating substantial equivalence to the predicate devices (Biotene Dry Mouth Oral Rinse K123731 and Hydris Oral Rinse K163029) in terms of Indications for Use, technological characteristics, safety, and effectiveness.
• Reported Device Performance:
  • Indications for Use: The device provides relief of symptoms and discomfort of dry mouth; refreshes, moisturizes, rehydrates, cleans, soothes oral irritation and lubricates oral dryness. It also freshens breath. These are largely identical to the predicate devices, with "freshens breath" being an additional claim.
  • Technological Characteristics: The device is a "formulation of water, humectants or moisturizers, thickening/binding agents, buffering agents, sweeteners, flavor, and colorant" for at-home oral cavity use.
  • Shelf-life: 36 months, same as the primary predicate device.
  • Physical Properties: Demonstrated substantial equivalence to predicate devices in Appearance, Color, Odor, pH, Viscosity, Specific Gravity, and Water Content through comparative physical property data.
  • Biocompatibility: Assessed in accordance with ISO 10993-1, demonstrating safety for use as directed.

The document provides a comparison table of the proposed device against the predicate devices (see page 5 and 6 of the original document). This table effectively serves as the "performance against criteria" for this type of submission.

Table of Performance Comparison (Derived from the document):

2. Sample size used for the test set and the data provenance

• Not Applicable. This submission did not involve a test set for clinical performance evaluation. Non-clinical tests were conducted on the device itself (e.g., shelf-life, physical properties, biocompatibility).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. No clinical test set or "ground truth" establishment by experts was part of this 510(k) submission.

4. Adjudication method for the test set

• Not Applicable. No clinical test set requiring adjudication was part of this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a medical device (oral rinse), not an AI-assisted diagnostic tool. No MRMC studies were performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a medical device (oral rinse), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. For the non-clinical tests conducted, the "ground truth" was based on established scientific methods for measuring physical properties, stability, and biocompatibility standards (e.g., pH meters for pH, viscometers for viscosity, ISO 10993-1 for biocompatibility). There was no "ground truth" in the clinical sense with patient outcomes or expert consensus.

8. The sample size for the training set

• Not Applicable. This product is an oral rinse, not a machine learning model. There was no training set.

9. How the ground truth for the training set was established

• Not Applicable. This product is an oral rinse, not a machine learning model. There was no training set or ground truth for it.

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