(1181 days)
An oral moisturizer which temporarily relieves the discomfort of dry mouth (xerostomia) and dry throat naturally. Salivart may be used to replace human saliva, when the amount of saliva normally secreted has been reduced. Salivart lubricates the mouth and throat to soothe discomfort and assist in speaking and swallowing. Salivart relieves dry mouth caused by certain medications, therapeutic treatments, diseases, normal aging and emotional factors.
Salivart Oral Moisturizer, an OTC device, is an aqueous electrolyte solution containing a viscosity agent and an emulsifier. The solution is aerosolized with a nitrogen propellant. It comes in two different can sizes. The smaller size is both sold and used as a promotional sample.
The provided text is a 510(k) summary for the Salivart® Oral Moisturizer, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission relies on a comparison of technological characteristics to a predicate device, rather than new clinical studies or performance data against specific acceptance criteria. Therefore, the document does not describe acceptance criteria, a study proving the device meets them, or many of the specific details requested in your prompt.
However, I can extract information related to the comparison of technological characteristics as presented:
1. A table of acceptance criteria and the reported device performance:
This document does not present acceptance criteria in the typical sense (e.g., minimum sensitivity/specificity for a diagnostic device). Instead, it relies on the concept of substantial equivalence to a predicate device. The "acceptance criteria" here are effectively that the device's technological characteristics are similar enough to the predicate to not raise new questions of safety and effectiveness.
| Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (Salivart® Oral Moisturizer) |
|---|---|---|
| Chemical Components | Must be "essentially the same" as predicate, or differences must not impact safety/effectiveness. | Uses "the same chemical components" as Moi-Stir® Mouth Moistener, except for the absence of a flavor and two preservatives. |
| Dispensing Mechanism | Must not raise new questions of safety or effectiveness compared to predicate. | Uses an aerosol mechanism, whereas the predicate uses a pump mechanism. |
| Intended Use | Must be the same as the predicate. | Same intended use as the predicate ("An oral moisturizer which temporarily relieves the discomfort of dry mouth (xerostomia) and dry throat naturally..."). |
2. Sample size used for the test set and the data provenance:
Not applicable. This is a 510(k) submission based on comparison to a predicate, not a study involving a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth was established by experts for a test set in this submission.
4. Adjudication method for the test set:
Not applicable. No test set or adjudication was performed.
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 oral moisturizer, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used:
Not applicable. Ground truth, in the context of diagnostic or AI studies, is not relevant to this 510(k) submission. The "truth" here is the prior marketing of the predicate device and its established safety and effectiveness.
8. The sample size for the training set:
Not applicable. This is a 510(k) submission, not a machine learning or algorithm development project.
9. How the ground truth for the training set was established:
Not applicable.
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