(117 days)
The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are intended to relieve the symptoms of dry mouth, refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness.
The GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray are specifically formulated as an artificial saliva substitute with water, moisturizers, humectants, sweeteners, and flavors that collectively have lubricating, moisturizing, and refreshing properties to help relieve and manage the symptoms of dry mouth (xerostomia).
The provided document, a 510(k) Pre-market Notification for GuruNanda Dry Mouth Oral Rinse and Spray, does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI/ML-based medical devices.
This document is a Substantial Equivalence (SE) Determination letter for a non-AI/ML device (dry mouth rinse and spray). In such cases, the primary method for demonstrating safety and effectiveness is by showing that the new device is substantially equivalent to a predicate device that is already legally marketed. This typically involves comparing intended use, technological characteristics, materials, and performance to the predicate device.
Therefore, many of the specific questions you've asked, which are highly relevant to the evaluation of AI/ML-based medical devices (e.g., sample size for test sets, number of experts, MRMC studies, standalone performance, ground truth establishment), are not applicable to this submission.
Here's a breakdown of what can be extracted from the document in relation to your questions, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense for this type of device. The 'acceptance criteria' for this submission are rooted in demonstrating substantial equivalence to the predicate device (Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray, K123731).
- The "reported device performance" is essentially the comparison table on pages 5-6, which shows an identical intended use, similar design, materials, chemical composition (with minor, stated differences in preservatives), and performance characteristics (e.g., appearance, color, odor, method of use, target population).
- Performance is demonstrated through:
- Biocompatibility testing: "Cytotoxicity, sensitization, irritation tested and passed in conformity with ISO 10993-5, ISO 10993-10, 10993-23." This is a key safety performance aspect for a device that contacts mucosal membranes.
- Chemical composition comparison: The document states that differences are minor and do not affect safety and effectiveness, and variations are "designated as GRAS ingredients, food additives or have a significant history of use in dental and medical or food applications."
2. Sample size used for the test set and the data provenance
- Not Applicable. This is not an AI/ML device that underwent a clinical performance study with a test set of patient data. Performance is primarily demonstrated through bench testing (like biocompatibility and chemical analysis) and comparison to a predicate.
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 the context of diagnostic or AI performance, is not a concept that applies to this type of device submission.
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 imaging or diagnostic device that would use human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device, and the demonstration that the new device shares fundamentally similar characteristics.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable.
Summary of Device Acceptance/Proof based on this Document:
The acceptance of the GuruNanda Dry Mouth Oral Rinse and Spray is based on its demonstration of Substantial Equivalence (SE) to a legally marketed predicate device (Biotene Dry Mouth Oral Rinse and Biotene Moisturizing Mouth Spray, K123731). The "study" proving this meets criteria is primarily a comparison and analysis of attributes rather than a clinical trial or AI performance study:
- Intended Use: Identical ("Relieve the symptoms of dry mouth: refresh, moisturize, clean, soothe oral irritation, and lubricate oral dryness.")
- Technological Characteristics: Very similar design, materials, and chemical composition. Minor differences in chemical composition (e.g., preservatives) are justified as not impacting safety or effectiveness, citing GRAS status or history of safe use.
- Performance: Demonstrated through:
- Biocompatibility testing: Confirmed to meet ISO standards (ISO 10993-5, 10993-10, 10993-23) for cytotoxicity, sensitization, and irritation.
- Chemical analysis: The variations in formula/composition are stated not to alter function or safety.
- Physical characteristics: Similar appearance, color, odor.
- Shelf-life: While the predicate had a 3-year shelf life and the new device a 2-year shelf life, this difference was presumably accepted as not raising new questions of safety or effectiveness.
In essence, the "proof" is that the device is so similar to an already cleared device that it does not raise new questions of safety or effectiveness.
N/A