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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.

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1. Provides symptom relief from Dry Mouth and low saliva including:

• Oral discomfort
• Mucosal soft tissue dryness
• Oral side effects of illness, therapies, and medications

2. Soothes moistens and lubricates
3. Hydrates soft tissue

MedActive Oral Gel and Spray are liquid delivery systems for ingredients that coat the inside of the mouth for a period of time and create relief from dry mouth symptoms in those who suffer oral malodor, discomfort, difficulties eating or speaking from dry mouth complications. They are applied by either a spray or gel to the user's mouth. MedActive Oral Gel and Spray are nonsterile ready to use devices to be used as needed or directed by a health care professional.

This document describes the premarket notification (510(k)) for MedActive Oral Gel and MedActive Oral Spray. This is a submission to demonstrate substantial equivalence to legally marketed predicate devices, not an AI/ML device, therefore much of the requested information (e.g. acceptance criteria, ground truth, sample size for training/test sets, expert qualifications, adjudication, MRMC studies) is not applicable.

Here's the available information relevant to product performance and testing:

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

• Biotene Spray (U4E291): 38.1%, 35.0%
• GC Gel (040109M): 17.4%, 13.9%
• MedActive Spray (4077): 56.9%, 57.8%
• MedActive Gel (2661015): 34.3%, 33.5%
  (The document states "result of the desorption testing shows that MedActive Oral Relief Gel and MedActive Oral Relief Spray perform similar to the predicate devices." While the numerical values show differences (e.g., MedActive Spray has higher % loss than predicate Biotene Spray, and MedActive Gel is similar to Biotene but higher than GC Gel), the conclusion drawn is similarity.) |
  | Rheology Testing | MedActive products exhibit viscosity and rheological behavior equivalent to predicate devices. | "The results of the rheological evaluation demonstrate the MedActive Oral Relief Gel and Spray exhibits viscosity and rheological behavior in equivalence to the predicate devices." |
  | Shelf Life Testing | MedActive products maintain form and function for a specified shelf life. | "The results of these rheology and desorption tests show that MedActive Oral Relief Gel and Spray exhibit similar form and function after three years of real time aging and result in a three year shelf life." |
  | Biocompatibility Testing | Results in accordance with ISO 10993 (for limited exposure mucosal membrane devices). | "The results from Acute Toxicity, Oral, Eye, and skin Irritation testing show biocompatibility results in accordance with ISO 10993." (Note: This was completed for MedActive Oral Gel, though not required for this device type). |
  | pH Testing | MedActive products perform similar to predicate devices in terms of pH. | pH Results:
• MedActive Spray: 5.78, 5.76 (Predicate Biotene Moisturizing Mouth Spray: 6.2-7.1)
• MedActive Gel: 5.35, 5.36 (Predicate GC Moisturizing Gel: 7.2; Predicate Laclede Oral Balance Liquid/Gel: 5.6)
  (The document states "the results of the pH testing shows that MedActive Oral Relief Gel and MedActive Oral Relief Spray perform similar to the predicate devices," while also noting that MedActive products have a "slightly more acidic pH than some predicate devices" due to preservatives.) |

2. Sample sized used for the test set and the data provenance:

• Desorption Testing: 2 samples of each product (MedActive Spray, MedActive Gel, Biotene Spray, GC Gel) were used. The provenance is not specified beyond being laboratory testing performed by the submitter.
• Rheology Testing: Not specified.
• Shelf Life Testing: Not specified for the initial tests, but "three years of real time aging" for the duration component.
• Biocompatibility Testing: Not specified.
• pH Testing: 2 samples of each Medactive product (VM 4077-1, VM 4077-2 for spray; OC266-1, OC266-2 for gel) were tested. The provenance is not specified beyond being laboratory testing performed by the submitter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a 510(k) submission for a non-AI/ML medical device based on physical and chemical equivalence to predicate devices, not requiring expert-labeled ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.

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 not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the typical sense for AI/ML devices. The "ground truth" for this 510(k) submission is the performance parameters (desorption, rheology, pH, etc.) of the legally marketed predicate devices, against which the applicant's device is compared. The intended use and technological characteristics are also deemed "ground truth" for comparison purposes.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable.

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