(97 days)
Relieves the symptom and discomfort of dry mouth, refreshes, moisturizes/hydrates, and lubricates oral dryness.
CloSYS® Dry Mouth Sensitive Mouth Rinse is an oral rinse designed to alleviate the symptoms of dry mouth for home use. The formulation includes water, humectants/ moisturizers, flavors, sweeteners, as well as ingredients with lubricating, soothing, and refreshing properties. The product is a ready-to-use, non-sterile, semi-viscous clear liquid, packaged in 16.0 FL OZ white High-Density Polyethylene (HDPE) bottles within a carton. Accelerated stability testing of the finished product supports a shelf life of 2 years. The rinse is formulated to have similar properties as predicate product Biotene Dry Mouth Oral Rinse Fresh Mint, which is a medical device 510(k) Number K123731 and the reference device Hydris™ Oral Rinse cleared under K163029. CloSYS® Dry Mouth Sensitive Mouth Rinse will be available in 16 fl oz (473 mL) PET bottles in a carton.
The provided FDA 510(k) clearance letter and summary for the CloSYS® Dry Mouth Sensitive Mouth Rinse focuses on establishing substantial equivalence to predicate devices, primarily through technological characteristics and non-clinical testing. This type of submission generally does not include extensive clinical studies or acceptance criteria tables related to device performance as you might find for novel drug or high-risk medical device approvals.
Therefore, many of the requested points regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, and standalone performance for an AI/software device are not applicable to this particular 510(k) summary for a dry mouth rinse.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria for specific performance metrics (like efficacy percentages, reduction in dry mouth symptoms, etc.). For this type of device, substantial equivalence is primarily evaluated based on similar indications for use, technological characteristics (ingredients, presentation, function), and safety (biocompatibility, stability).
The "performance" reported is related to safety and stability, rather than clinical efficacy against a specific quantitative target.
| Acceptance Criteria Category | Reported Device Performance (from "Discussion and Conclusions from the Nonclinical and Clinical Tests") |
|---|---|
| Safety | - Biocompatibility: Demonstrated to be safe through standard biocompatibility testing (Sensitization, Mucosal Irritation, Cytotoxicity) in accordance with ISO 10993. |
- Results: Assays demonstrated an acceptable biocompatibility profile consistent with the predicate. |
| Stability | - Stability Studies: Stability of the finished product is monitored at room temperature and under accelerated conditions. - Results: Accelerated stability testing supports a shelf life of 2 years. |
| Technological Equivalence| - Same Intended Use: Relieves symptom and discomfort of dry mouth, refreshes, moisturizes/hydrates, lubricates oral dryness. - Same Technology: Ready-to-use liquid, similar ingredients/solvents/moisturizers/sweeteners/thickeners. |
2. Sample sizes used for the test set and the data provenance
Not applicable in the context of this 510(k) for a dry mouth rinse. The non-clinical studies mentioned (biocompatibility, stability) would have their own sample sizes (e.g., number of cell cultures, animal subjects, or product batches tested), but these are not specified in this summary. There is no "test set" here in the sense of a clinical trial cohort or an AI model's validation dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" derived from expert consensus for clinical performance in this submission. Safety assessments (biocompatibility) would be evaluated by toxicologists/biocompatibility specialists, and stability by analytical chemists, but these are not clinical "experts" establishing a disease-related ground truth in the manner implied by the question.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication method is described in this 510(k) summary.
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 mouth rinse, not an AI or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a medical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety studies, the "ground truth" is based on established scientific methods and ISO standards for biocompatibility (e.g., cell viability, irritation scores, sensitization reactions). For stability, it's based on analytical measurements over time compared to pre-defined specifications. There is no clinical "ground truth" (like pathology results for a diagnostic device) mentioned for this type of product in this summary.
8. The sample size for the training set
Not applicable. There is no "training set" for this kind of medical device approval. This concept applies to machine learning models, not physical products like a mouth rinse.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for it.
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