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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.

Device Description

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.

AI/ML Overview

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.

Performance Attribute	Acceptance Criteria (Implicit: Similar to Predicate)	Reported Device Performance (OraLabs Dry Mouth Pocket Spray)	Predicate Device Performance (Biotene Moisturizing Mouth Spray)
Appearance	Similar to predicate	Cloudy, semi-viscous	Cloudy, semi-viscous
Sensory Properties	Similar to predicate	Tested favorably to predicate	N/A (implied similar to OraLabs)
pH	Appropriate range for oral cavity	5.2 – 7.2	6.02, 6.11
Viscosity	Similar to predicate	5120 mPa*s	7700 mPas; 7820 mPas
Moisture Deabsorption	Similar to predicate	9.97%	8.16%
Solubility	Water Soluble	Water Soluble	Water Soluble
Biocompatibility (Cytotoxicity)	Safe for oral use (similar to predicate)	Fail (similar to predicate due to preservatives)	Fail (similar to OraLabs due to preservatives)
Biocompatibility (Sensitization)	Pass	Pass	N/A (implied similar to OraLabs)
Biocompatibility (Irritation or Intracutaneous Reactivity)	Pass	Pass	N/A (implied similar to OraLabs)
Stability (Shelf-Life)	Demonstrated stability for claimed duration	Supports 24 months	Supports 36 months
Preservative Efficacy (USP)	Acceptable for expiration date	Acceptable for expiration date (no growth)	N/A (implied acceptable)
Elemental Impurity	Acceptable results	Acceptable results	N/A (implied acceptable)

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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