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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.

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The Absolute White Light emits visible blue light in the 400 nanometer spectrum and is intended to provide a light source for bleaching teeth.

The Absolute White Light is intended for use by the end consumer. The Absolute White Light is a battery operated, hand held device that contains a hun vosible light in the 400 nanometer spectrum, which can penetrate the tooth and activate the photoactive substances within the tooth yielding a minimal amount of heat. Built in safety features include automatic light shut off after two minutes and "Light Guard" that prevents light exposure to the user's eyes.

The provided document describes the Absolute White Light, a device intended to provide a light source for bleaching teeth. However, it does not include a study that proves the device meets specific acceptance criteria in terms of efficacy or performance on human subjects for tooth whitening. Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety standards.

Here's a breakdown based on your request, highlighting what is present and what is absent:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., a specific percentage improvement in tooth shade) for the Absolute White Light. Instead, it relies on demonstrating that the device is "substantially equivalent" to a legally marketed predicate device (Dentovations Luster Whitening System) in terms of its intended use and technical characteristics.

The "performance data" section primarily refers to compliance with quality system regulations and safety standards, not clinical efficacy data.

Table of Comparison with Predicate Device (acting as the basis for "performance" as substantial equivalence):

Additional "Performance Data" (Compliance, not clinical efficacy):
The device is manufactured in compliance with:

• Quality System Regulations (21 CFR 820)
• DIN EN ISO13485:2003
• DIN EN ISO 9001:2000
• EN 61000-6-1 Electromagnetic compatibility (EMC) Part 6-1: Immunity standard for residential, commercial and light-industrial environments
• EN61000-6-3 Electromagnetic compatibility (EMC) Part 6-3: Emission standard for residential, commercial and light-industrial environments

Study Details (or lack thereof)

Based on the provided text, there is no specific clinical study or performance study presented that directly proves the device's efficacy in terms of tooth whitening (e.g., changes in shade). The submission relies on demonstrating substantial equivalence to a predicate device, implying that since the predicate device is already cleared for use, a device with similar characteristics and intended use is also safe and effective.

Therefore, the following points cannot be addressed with the provided text, as no such study is described:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, no clinical test set described for efficacy.
2. 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 described for efficacy.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no clinical test set described for efficacy.
4. 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 not an AI/imaging diagnostic device. No MRMC study was conducted.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is not an AI/imaging diagnostic device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, no clinical ground truth for efficacy was established or reported. The "ground truth" for regulatory clearance was the substantial equivalence to the predicate device based on technical specifications and safety standards.
7. The sample size for the training set: Not applicable, no machine learning model or training set is described.
8. How the ground truth for the training set was established: Not applicable, no machine learning model or training set is described.

Conclusion from the document:

The regulatory approval (K110888) was granted based on the determination of "substantial equivalence" of the Absolute White Light to the predicate device (Dentify Luster Whitening System, K042153). This means the FDA concluded that the new device has the same intended use and similar technological characteristics to a device already on the market and does not raise different questions of safety and effectiveness. The "performance data" provided focuses on manufacturing quality systems and adherence to electromagnetic compatibility (EMC) standards, not on clinical performance demonstrating tooth whitening efficacy in human subjects.

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