(259 days)
RX: GC Oral Moisturizing Gel is designed to provide comfort for individuals suffering from dry mouth. It is recommended to be used for people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth. OTC: GC Oral Moisturizing Gel is indicated for the relief of dry mouth symptoms, to provide a protective coating inside the mouth, and help to control bad breath.
GC Oral Moisturizing Gel contains polyglycerol (diglycerol) which, with other ingredients in the product, temporarily substitute the feel of natural saliva to moisturize, lubricate, and refresh the mouth. GC Oral Moisturizing Gel comes in five flavors: fruit salad, lemon, mint, orange and raspberry. GC Oral Moisturizing Gel is sugar free and alcohol free.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the GC Oral Moisturizing Gel:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are primarily based on comparisons to predicate devices in physical properties (Consistency, pH) and a single performance metric (Moisture Desorption Assay). The document argues for substantial equivalence rather than setting hard numerical thresholds for acceptance in the traditional sense of a clinical trial. However, we can interpret the predicate device values as targets or benchmarks for equivalence.
| Metric | Acceptance Criteria (Predicate Device Range/Value) | Reported Device Performance (GC Oral Moisturizing Gel) | Meets Criteria? |
|---|---|---|---|
| Consistency (mm) | 26.5 - 28.0 (BioXtra/Oral Balance) | 32.5 | No |
| pH | 5.4 - 5.6 (BioXtra/Oral Balance) | 7.2 | No |
| Moisture Desorption Degree (%) | 10.1% (Biotene Oral Balance) | 6.9% | Yes (Lower is better) |
Notes on Meeting Criteria:
- Consistency and pH: The GC Oral Moisturizing Gel's reported values fall outside the range of its predicate devices for both consistency and pH. The submission argues for substantial equivalence despite these differences, focusing on the shared "mode of action" and intended use. This suggests the FDA accepted these differences, likely because the performance (moisture desorption) was superior or equivalent, and the overall safety and effectiveness were not compromised.
- Moisture Desorption Degree: The GC Oral Moisturizing Gel performs better than the predicate device (Biotene Oral Balance) in the moisture desorption assay, indicating it retains moisture more effectively.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" in the context of human subjects or a clinical study. The performance data presented (Consistency, pH, Moisture Desorption Assay) appears to be from laboratory testing of the product itself, not from a clinical trial involving human subjects.
- Data Provenance: "According to GC Corporation R & D test methods." This indicates the tests were conducted internally by the manufacturer. No country of origin for data subjects or whether it was retrospective/prospective is applicable here, as no human data is presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for the physical and performance tests was established by direct laboratory measurement and comparison to the predicate devices, not by expert consensus on clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication. The physical tests were direct measurements.
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 a medical product (moisturizing gel), not an AI-powered diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device. The "standalone performance" of the gel is represented by the physical and moisture desorption tests.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the physical and performance characteristics was established through laboratory measurements and direct comparison to the physical properties of legally marketed predicate devices. For the "substantial equivalence" argument, the ultimate ground truth relied on the prior regulatory acceptance and safety profile of the predicate devices and their components.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set." The product's formulation was developed based on understanding chemical properties and desired effects, likely through iterative laboratory development.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set in the AI sense, there's no ground truth establishment for it. The formulation development would have been driven by material science principles and performance targets.
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