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

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

Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness.

Biotène Dry Mouth Oral Rinse is a specially formulated artificial saliva substitute which contain moisturizers, humectants, a protein, and patented salivary enzymes, that collectively have lubricating, moisturizing, soothing, and refreshing properties to relieve & treat the symptoms of Dry Mouth. The liquid products are supplied in PET bottles of various sizes, including an 8 oz., 16 oz., and 33.8 oz., and also 15 ml. multilayer laminated foil pouches.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in a quantitative manner.

The document is a 510(k) summary for a medical device (Biotène Dry Mouth Oral Rinse) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with acceptance criteria and performance metrics.

Here's a breakdown of what is and is not available in the provided text regarding your request:

Information Present in the Document:

• Device Description: Biotène Dry Mouth Oral Rinse is an artificial saliva substitute containing moisturizers, humectants, a protein, and salivary enzymes to relieve and treat dry mouth symptoms.
• Intended Use/Indications for Use: Relieves the symptoms of dry mouth; refreshes, moisturizes, cleans, soothes oral irritation, and lubricates oral dryness.
• Predicate Devices: Laclede, Inc. Oral Balance Gel (K061331) and Oral Balance Liquid (K061331).
• Nonclinical Tests: The document states that "Biotène Dry Mouth Oral Rinse has been shown in non-clinical studies to be safe (Toxicology Assessments), and stable (Stability Studies) for its intended use."
• Clinical Tests: It states, "It has also been shown in clinical studies to be effective (Use Studies)." It then specifies, "No other clinical tests were performed other than a Use Study for this submission."

Information NOT Present in the Document (and therefore cannot be provided by me):

• A table of acceptance criteria and reported device performance: This is completely absent. The document only states it was shown to be "effective" in "Use Studies" but provides no quantitative results, metrics, or comparison to specific acceptance thresholds.
• Sample sized used for the test set and the data provenance: While a "Use Study" is mentioned, no details about its design, sample size, or data provenance are provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not mentioned, as no specific ground truth or expert consensus method for a test set is described.
• Adjudication method for the test set: Not applicable or not mentioned.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. This type of study is more common for imaging diagnostics, not typically for oral rinse effectiveness.
• Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical product, not an algorithm.
• The type of ground truth used: Not explicitly stated. For a "Use Study," it would likely be patient-reported outcomes or clinical assessment of dry mouth symptoms, but no specifics are given.
• The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device requiring a training set in that context.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided text serves as a regulatory submission (510(k) summary) focused on demonstrating substantial equivalence, not a detailed scientific report on a specific study with acceptance criteria and quantitative performance metrics. While it mentions "Use Studies" proving effectiveness, it does not elaborate on the methodology, results, or specific criteria met.

Ask a specific question about this device