(119 days)
Relieves the symptoms and discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation and lubricates oral dryness.
Provides long lasting relief for up to 6 hours.
The Oral-B® Dry Mouth Oral Rinse is a non-sterile clear liquid formulated as an artificial saliva (LFD) intended to be marketed over the counter for at-home use. The artificial saliva for dry mouth is formulated with gel film forming polysaccharides, sodium hyaluronate, which possess lubricating and moisturizing properties. Oral-B® Dry Mouth Oral Rinse also contains water, moisturizers/humectants, thickener, surfactant, pH adjusters, preservative, sweetener and flavor that collectively form the device formulated at a pH of 6 and designed to help relieve and manage the symptoms of dry mouth. A list of device components can be found in Table 5-1. None of the constituents used in the device are novel materials not previously used in a legally marketed US-medical device).
The device is intended to be used for 30 seconds each use, up to five times daily for consumers 12 years or older. Oral-B® Dry Mouth Oral Rinse is supplied in a 16-fluid ounce white Polyethylene Terephthalate (PET) bottle, with a white polypropylene closure and a clear polypropylene dosing cup.
Here's an analysis of the acceptance criteria and study as described in the provided document:
This document is a 510(k) summary for the Oral-B® Dry Mouth Oral Rinse (K203567), which seeks to update its "Indications for Use" from providing relief for "up to 4 hours" to "up to 6 hours." The device itself is identical to a previously cleared predicate device (K201277).
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document presents the acceptance criteria implicitly through the study's objective: to demonstrate longer-lasting relief. The performance is reported as the outcome of that demonstration, not against explicit, pre-defined quantitative thresholds in the same way one might see for, say, diagnostic accuracy.
| Acceptance Criteria (Implied) | Reported Device Performance (K203567) |
|---|---|
| Demonstrate efficacy in relieving dry mouth symptoms immediately post-use. | Oral-B® Dry Mouth Oral Rinse was more effective than water at providing immediate dry mouth moisturization. |
| Demonstrate efficacy in relieving dry mouth symptoms up to 6 hours post-use. | Oral-B® Dry Mouth Oral Rinse was more effective than water at providing overnight and up to 6 hours of relief of dry mouth symptoms. |
| Support the modified "Indications for Use" statement: "Provides long lasting relief for up to 6 hours". | Analysis of the clinical study results support the Indication for Use statement of "Provides long lasting relief for up to 6 hours". The majority of study subjects using the subject device achieved dry mouth symptom relief at all time points including 4- and 6- hours post-treatment. |
| No new safety concerns compared to predicate. | No formulation/technological changes from the predicate; device is considered as safe as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number. The document mentions "subjects with self-reported dry mouth symptoms."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "controlled, randomized, 3-treatment, parallel clinical study," indicating it was prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The study used "an Oral Examination" to identify subjects who experienced dry mouth symptoms. It's not specified how many experts conducted these examinations or their particular qualifications (e.g., dentist, physician, etc.).
- Ground truth was also partly established by "subject responses to the Dry Mouth Inventory (DMI) questionnaire," which is a self-reported measure.
4. Adjudication Method for the Test Set
- The document does not mention an adjudication method for the test set or for establishing ground truth. The primary endpoints appear to be direct comparison of product efficacy against a control based on symptom relief.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This study evaluated the direct clinical effect of an oral rinse on dry mouth symptoms, not the performance of an AI algorithm assisted by human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This document describes a medical device that is an oral rinse, not an AI algorithm. Therefore, there is no "algorithm only" performance to report.
7. Type of Ground Truth Used
- The ground truth for effectiveness was based on a combination of:
- Clinical assessment: "Oral Examination" to determine dry mouth symptoms.
- Patient-reported outcomes: "subject responses to the Dry Mouth Inventory (DMI) questionnaire" measuring dry mouth symptom relief.
8. Sample Size for the Training Set
- N/A. As this is not an AI/machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- N/A. As this is not an AI/machine learning device, there is no "training set" or ground truth establishment for one.
N/A