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Use as needed for instant relief. OraLabs Dry Mouth Pocket Spray helps maintain the oral environment and helps provide protection against dry mouth symptoms.

OraLabs Dry Mouth Pocket Spray is a specially formulated water soluble artificial saliva substitute with a pH between 5.20 to 7.20 for use at home in the oral cavity. OraLabs manufactures the products in a 0.25 FL OZ polyethylene bottle with a non-aerosol pump. The formula contains water, moisturizers, thickeners/binders, buffers, flavor, sweetener and preservatives. The combination of ingredients collectively provides moisturizing, lubricating, soothing, and refreshing properties.

This document describes the premarket notification for OraLabs Dry Mouth Pocket Spray, and outlines its substantial equivalence to the predicate device, Biotene Moisturizing Mouth Spray. It is important to note that this document pertains to a device that delivers a substance (dry mouth spray) and not an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. Therefore, the questions related to AI/ML specific criteria (e.g., ground truth establishment for training sets, MRMC studies, AI assistance effect size) are not applicable to this submission.

Here's a breakdown of the information provided, addressing the applicable questions:

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

The document does not explicitly present "acceptance criteria" in a typical tabular format with pass/fail metrics. Instead, it describes performance testing conducted to demonstrate "substantial equivalence" to the predicate device. The performance data presented below indicates comparative results used to support this claim, rather than pre-defined acceptance thresholds.

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

The document does not specify sample sizes for most of the performance tests (e.g., pH, viscosity, moisture deabsorption, appearance, sensory properties, elemental impurity).

For biocompatibility testing, it's implied that individual samples of both OraLabs and Biotene products were tested. The specific number of replicates/samples for cytotoxicity, sensitization, and irritation is not stated.

For stability testing, the product was filled into "individual spray bottles," and tested at Baseline, 3 months, and 6 months intervals. The exact number of bottles/samples tested at each interval is not specified.

The data provenance is from OraLabs, Inc. (Parker, Colorado, USA) and is prospective as it involves the testing of their new device.

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

This question is not applicable. This is a medical device (a spray product), not an AI/ML device requiring expert ground truth for classification or diagnosis. The "ground truth" for this type of device is established through physical and chemical property testing, and comparison to a legally marketed predicate device.

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

This question is not applicable. There were no human expert adjudications for the test results of this product. The evaluation relies on laboratory test results.

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

This question is not applicable. This is not an AI/ML powered device, and therefore no MRMC study involving human readers or AI assistance was conducted.

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

This question is not applicable. This is not an AI/ML powered device, and therefore no standalone algorithm performance was assessed.

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

The "ground truth" for mechanical/chemical performance was established through laboratory testing (e.g., pH meters, viscometers, chemical analysis, microbiological assays, biocompatibility assays). For the purpose of regulatory clearance, the implicit ground truth is that the device should demonstrate substantially equivalent performance characteristics to the legally marketed predicate device (Biotene Moisturizing Mouth Spray) in terms of safety and basic functionality.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML powered device, and therefore no training set was used.

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

This question is not applicable. This is not an AI/ML powered device, and therefore no training set or its ground truth were established.

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The Oral B plus Scope Outlast Nighttime Dental Guard is an Over-the-Counter dental guard indicated for the protection against bruxism - the nighttime clenching and grinding of the teeth.

It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated teeth grinding.

a mouthguard constructed of a propylene-based elastomer. The target area is the oral cavity of individuals that suffer from bruxism, nighttime teeth grinding.

The device works by molding the thermoplastic resin to the individual's mouth. The thermoplastic resin can be molded after submerged in boiling water via the microwave. The molded thermoplastic resin is worn at to reduce damage to the teeth and to prevent the noise associated teeth grinding.

OraLabs Oral-B plus Scope Outlast Nighttime Dental Guard is intended for individuals age 18 and older. Thermoplastic can be molded to fit all sizes.

This 510(k) submission (K113326) for the Oral-B plus Scope Outlast Nighttime Dental Guard focuses on biocompatibility testing as its primary performance data because it is a medical device, and the device is claiming substantial equivalence to a predicate device (Dentek's Custom Comfort Dental Guard, K083400) which would have already established its functional efficacy for bruxism. Therefore, the acceptance criteria and study described here are centered on ensuring the safety of the new device for human contact, particularly due to the addition of flavor.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The study primarily involved biocompatibility testing on biological models, not a human clinical test set in the traditional sense for efficacy.

• MEM Elution (Cytotoxicity): L-929 Mouse Fibroblast Cells
• Guinea Pig Maximization Sensitization Test: Not explicitly stated, but typically involves a number of guinea pigs (e.g., 10-20 per group).
• Intracutaneous Irritation Test: 3 Rabbits
• Acute Systemic Injection Test: Not explicitly stated, but typically involves a number of animals (e.g., mice).
• SubChronic (14-day) Intravenous Toxicity Study: Non-Swiss Webster Mice (number not specified, but usually involves multiple groups with a control).

Data Provenance: The studies are laboratory-based biocompatibility tests, not tied to a specific country of origin for human data or retrospective/prospective human studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable in the context of this biocompatibility study. The "ground truth" for these tests is established by recognized international standards (ISO 10993 series) and laboratory best practices, not expert consensus on human cases.

4. Adjudication Method for the Test Set:

Not applicable. Biocompatibility tests have specific endpoints and interpretations as outlined in the ISO standards. The results are typically quantitative or qualitative (pass/fail) based on established thresholds, not subject to expert adjudication of individual cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This submission is for a physical medical device (dental guard) where the primary concern is safety and functional equivalence, not diagnostic accuracy requiring human reader interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

Not applicable. This device is a physical dental guard, not an algorithm or AI system.

7. Type of Ground Truth Used:

The ground truth used for this submission is based on International Standards (ISO 10993 series) for biocompatibility. These standards define the acceptable biological responses to medical devices.

8. Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of this device and the type of performance testing performed. AI/ML models use training sets, but this is a physical device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set.

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