Search Results

Relieve symptoms of dry mouth, refresh, moisturize, clean and sooth oral irritation, and oral dryness.

Salivea Dry Mouth Mouthwash and Salivea Dry Mouth Mouthspray are specially formulated saliva substitute which contain moisturizers, humectants and salivary enzymes that collectively have lubricating, moisturizing, soothing and refreshing properties to relieve and treat the symptoms of dry mouth.

The Salivea Dry Mouth MouthSpray is supplied in non-pressurized pump action spray white Polyethylene terephthalate bottle.

The Salivea Dry Mouth Mouthwash is supplied in white Polyethylene terephthalate bottle.

This document is a 510(k) Summary for the Salivea Dry Mouth Mouthwash and Mouthspray. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on nonclinical testing.

Here's a breakdown of the requested information, however, it's crucial to understand that this document DOES NOT contain information on clinical studies involving human patients or complex AI algorithms that would require MRMC studies, multi-reader consensus, or large training/test sets for AI models. This is a clearance for a simple medical device (a mouthwash/mouthspray) based on nonclinical testing for biocompatibility and physical properties, not a high-tech AI diagnostic device.

Therefore, many of the requested points are not applicable to this 510(k) submission.

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

The document provides acceptance criteria for nonclinical testing (biocompatibility and physical properties) and states that the results met these criteria. It does not provide detailed quantitative performance data for these tests other than stating they "met the acceptance criteria" or "were comparable."

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

• Test Set Sample Size: Not applicable. This refers to the number of subjects or cases in a clinical trial or AI model validation. For the nonclinical tests referenced (biocompatibility, physical properties, stability), the "sample size" would relate to the number of test articles or batches tested, which is not specified in this summary. These are laboratory tests, not human trials or large image datasets.
• Data Provenance: Not applicable in the context of clinical data. These are laboratory test results, presumably conducted by or for the manufacturer (Laclede, Inc.) in the US, as the company is based in California. The tests are standard industry practices.

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

• Not Applicable. Ground truth in this context typically refers to expert labels for clinical data (e.g., radiologists interpreting images). This device clearance is based on laboratory testing, not expert clinical interpretation of patient data. The "ground truth" for these tests are the objective measurements and observations from the validated laboratory assays themselves (e.g., pH meter readings, visual assessment for irritation, etc.).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods are used in clinical studies or AI model evaluations where multiple human readers disagree on a diagnosis or finding. This document describes laboratory testing where outcomes are objective measurements or standardized observations.

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

• No, a MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices where the AI assists human readers in interpreting clinical data. This is a simple medical device (mouthwash/mouthspray) where there is no AI component or human reader interpretation involved.

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

• Not Applicable. There is no algorithm for this device.

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

• Objective Laboratory Test Results: The "ground truth" for the nonclinical testing were the established scientific methods and resulting measurements/observations from biocompatibility tests (e.g., lack of inflammation, no signs of toxicity) and physical property measurements (e.g., pH values, viscosity measurements). There is no "pathology" or "outcomes data" in the clinical sense for this type of device clearance.

8. The sample size for the training set

• Not Applicable. This device is not an AI model, so there is no training set.

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

• Not Applicable. Since there is no training set, there is no ground truth for a training set to be established.

In summary, this 510(k) Summary focuses on demonstrating the substantial equivalence of a general medical device (mouthwash/mouthspray) to legally marketed predicate devices through nonclinical bench testing and ingredient comparison. It does not involve complex clinical studies, AI algorithms, or extensive human reader evaluations typically associated with the detailed questions posed.

Ask a specific question about this device