Search Results

Relieves the symptoms of dry mouth, cleans, soothes oral irritation, lubricates and moisturizes dry mouth irritation and diminishes dry discomfort. Indications for Use: Relieves the symptoms of dry mouth, while moisturizing and lubricating oral dryness.

Dr. Fresh Dry Mouth Mouthwash is a specifically formulated artificial saliva substitute which contains moisturizers, humectants and patent pending salivary enzymes that have lubricating, moisturizing and soothing properties to relieve the symptoms of Dry Mouth. The liquid product is supplied in 1.5 oz, 16 oz and 33.8 oz PET bottles.

This document describes a 510(k) premarket notification for a medical device, specifically Dr. Fresh Dry Mouth Mouthwash, and focuses on demonstrating substantial equivalence to a predicate device. This type of submission does not typically involve detailed clinical studies with acceptance criteria based on quantifiable performance metrics of the device as it would for a novel device. Instead, the "study" is a comparison to an already approved device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically defined by demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, and that any differences do not raise new questions of safety or effectiveness. The reported "device performance" is the comparison itself.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable in the context of this 510(k) summary. There is no "test set" of patient data for performance evaluation in the way a clinical trial would have. The "test" is the comparison of characteristics.
• Data Provenance: Not applicable. The "data" are the technical characteristics of the device being compared to a predicate, not patient data from a study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. Ground truth, in the sense of expert consensus on patient outcomes or diagnoses, is not established for this type of submission. The "ground truth" is essentially the established characteristics and regulatory approval of the predicate device. The FDA's review committee (Division of Anesthesiology, General Hospital, Infection Control and Dental Devices) acts as the expert body determining substantial equivalence.

4. Adjudication Method for the Test Set

• Not applicable for the reasons stated above. The "adjudication" is the FDA's regulatory decision based on the submitted information.

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 device is an artificial saliva substitute, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is irrelevant to this submission.

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

• Not applicable. This device is a physical product (mouthwash), not an algorithm or an AI system.

7. The Type of Ground Truth Used

• The "ground truth" in this context is the established regulatory acceptance and performance profile of the legally marketed predicate device, GlaxoSmithKline Consumer Healthcare Biotene Dry Mouth Oral Rinse (K101477). The substantial equivalence argument relies on demonstrating that the new device is sufficiently similar to this already approved device.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable, as there is no training set for this type of device submission.

Ask a specific question about this device