(156 days)
- Elevate Moisturizing Spray is indicated to provide comfort for individuals suffering from dry mouth. It is recommended to be used by people who may experience difficulties in eating, speaking or are suffering from discomfort due to dry mouth.
- Elevate Moisturizing Spray is indicated for rapid relief of dry mouth symptoms, to provide a protective coating inside the mouth and to help control bad breath.
- A mouth spray that quickly reduces mouth discomfort, oral malodor and other symptoms of dry mouth.
Elevate Moisturizing Spray is a viscous liquid dispensed from a spray bottle into the mouth. The spray will coat the inside of the mouth for a period of time and create relief from dry mouth symptoms in those who suffer oral malodor, discomfort, difficulties eating or speaking from dry mouth complications.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Elevate Moisturizing Spray, formatted to answer your questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" for clinical performance. Instead, it relies on demonstrating substantial equivalence to predicate devices through a comparison of physical properties and general indications for use. The closest we can get to performance data is the desorption testing.
| Acceptance Criteria (Implied) | Reported Device Performance (Elevate Moisturizing Spray) | Predicate Device 1 (Biotene Mouth Spray) Performance | Predicate Device 2 (GC Mint Moisturizing Gel) Performance |
|---|---|---|---|
| Moisture Desorption Degree | 21.96% | 36.8% | 17.15% |
| Interpretation: The device demonstrates a moisture loss that is within the range of, and in fact lower than, one predicate (Biotene), suggesting comparable or potentially better moisture retention in this specific test. It is higher than the other predicate (GC Mint Moisturizing Gel). The document implies that this range is acceptable for substantial equivalence. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The "test set" in this context refers to the samples used in the "Summary of Physical Tests," specifically the Desorption Testing. For this test, it states that "0.4g of each product was placed on a weighing dish." This implies a small, laboratory-scale sample size for each product, likely a single measurement or a very small number of replicates per product. The exact number of replicates is not specified.
- Data Provenance: Not explicitly stated. This appears to be laboratory testing conducted by the manufacturer or a contracted lab. There is no information regarding the country of origin or whether it's retrospective or prospective, though lab tests are generally considered prospective in their execution.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The "test set" for the physical desorption testing does not involve human expert ground truth. It's a laboratory measurement of a physical property.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The physical desorption testing does not involve human readers or adjudication.
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 spray, not an AI software or diagnostic imaging device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an artificial saliva spray, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the Desorption Testing, the "ground truth" is the objective physical measurement of weight loss after incubation. There is no biological or clinical "ground truth" in the typical sense for this specific test.
For the overall substantial equivalence determination, the "ground truth" is
- Chemical Composition: Comparison of ingredients and their classification (GRAS, approved food additives).
- Intended Use & Indications: Direct comparison to the stated indications of legally marketed predicate devices.
- Mode of Action: Comparison to the known physiological effects of artificial saliva products.
8. The sample size for the training set
Not applicable. This is a medical device (artificial saliva spray), not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
Summary of Device Performance and Equivalence Claim:
The submission for the Elevate Moisturizing Spray primarily relies on demonstrating substantial equivalence to predicate devices (Biotene Moisturizing Mouth Spray and GC Moisturizing Gel) rather than establishing novel clinical performance against strict acceptance criteria.
The key arguments for substantial equivalence are:
- Similar Indications for Use: The stated indications for providing comfort, rapid relief of dry mouth symptoms, protective coating, and controlling bad breath are presented as similar to the predicate devices.
- Similar Technological Characteristics: The chemical composition and mode of action are claimed to be similar to the predicate devices, despite some variations in specific ingredients (solvents, mucoadhesive agents, rheology modifiers, preservatives).
- Physical Testing (Desorption): The device's moisture loss (21.96%) is within the range observed for the predicate devices (Biotene at 36.8%, GC Mint at 17.15%), supporting its ability to retain moisture.
- Biocompatibility and Risk Assessment: Information was provided to confirm safety based on ISO 10993 and ISO 14971, though no details of these assessments are given in the provided text.
- Ingredient Classification: Ingredients are either used in predicate devices, listed as GRAS, or approved food additives.
The FDA's letter states that they "have determined the device is substantially equivalent... to legally marketed predicate devices," affirming that the provided data (including the physical tests and comparisons) met their requirements for equivalence.
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