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510(k) Data Aggregation
(119 days)
Oral-B Dry Mouth Oral Rinse
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.
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(112 days)
Oral-B Dry Mouth Oral Rinse
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 4 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.
The provided text describes the regulatory clearance for the Oral-B® Dry Mouth Oral Rinse and details its characteristics and performance. Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance for this device is based on a "substantial equivalence" determination rather than specific pre-defined acceptance criteria for performance metrics in the way a diagnostic device might have. Substantial equivalence means the device is as safe and effective as a legally marketed predicate device. The performance data presented focuses on demonstrating this equivalence.
| Feature / Criteria | Acceptance (Implied by Substantial Equivalence Determination) | Reported Device Performance |
|---|---|---|
| Intended Use | Relief of dry mouth symptoms, similar to predicate. | Relief of dry mouth symptoms (Matches predicate). |
| Indication for Use | Relieves symptoms & discomfort of dry mouth, refreshes, moisturizes/hydrates, soothes oral irritation, lubricates oral dryness, and provides long-lasting relief (up to 4 hours), similar to predicate and supported by clinical data. | 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 4 hours. (Supported by clinical study showing effectiveness vs. water and potential superiority to comparator). |
| Biocompatibility | Consistent with ISO 10993-1 and predicate device. | Demonstrated consistent with FDA guidance "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." |
| Chemical & Physical Properties (pH, Viscosity, etc.) | Comparable to predicate device such that differences do not raise safety/effectiveness concerns. | pH: 5.5 - 6.4 (Predicate: 5.5-7.0) |
| Viscosity: > 29 cP (Predicate: 20.39 Sct (22.0 cP*)) | ||
| Specific Gravity: 1.04 (Predicate: 1.06) | ||
| Surface Tension: Not explicitly quantified for subject, but "comparative chemical and physical property data... support a finding of substantial equivalence." | ||
| Shelf Life Stability | Demonstrated 24-month shelf life. | Shelf life stability testing provides for a 24-month shelf life of the subject device. |
| Effectiveness in Relieving Dry Mouth Symptoms | More effective than water for immediate moisturization and long-term relief, and demonstrates up to 4 hours duration of effect. | Clinical study demonstrated Oral-B® Dry Mouth Oral Rinse was more effective than water at providing immediate dry mouth moisturization and overnight and long-term relief of dry mouth symptoms. Pilot study results supported duration of effectiveness for up to 4 hours. |
| Safety | No novel materials not previously used in legally marketed US-medical devices, and no concerns raised by compositional differences compared to predicate. | "None of the constituents used in the device are novel materials not previously used in a legally marketed US-medical device)." Compositional differences "do not raise any concerns of safety and effectiveness." |
Note: The "acceptance criteria" here are implied by the FDA's regulatory standard of substantial equivalence to a predicate device, rather than specific numerical targets for performance metrics often seen in diagnostic AI/ML device clearances.
2. Sample size used for the test set and the data provenance
- Sample Size for the test set: Not explicitly stated as a separate "test set" in the context of an algorithm evaluation. The clinical study was a controlled, randomized, 3-treatment, 3-period crossover clinical study. The number of participants in this study is not specified in the provided text.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): The clinical study was described as "conducted" which implies prospective data collection. The country of origin of the data is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an oral rinse, not a diagnostic imaging or AI device requiring expert ground truth for a test set. The clinical study evaluated subjective symptom relief and objective measures related to dry mouth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a diagnostic device requiring adjudication of expert readings.
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 an oral rinse, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an oral rinse, not an algorithm. The "device performance" refers to the product's physical and clinical efficacy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical study, the "ground truth" or primary outcome measures were likely:
- Subjective symptom relief: Patient-reported experiences of dry mouth moisturization and relief.
- Duration of effect: Measured time until symptoms returned or relief diminished.
- The comparison to water served as a control.
8. The sample size for the training set
Not applicable. This is a physical product (oral rinse) and does not involve AI/ML or a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical product (oral rinse) and does not involve AI/ML or a training set.
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