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510(k) Data Aggregation
(85 days)
MI Varnish is a fluoride varnish with Recaldent™ (CPP-ACP) that has a desensitizing action when applied to tooth surfaces. The application leaves a film of varnish on tooth and this may allow visual control and verification.
MI Varnish is a fluoride varnish (5% sodium fluoride with CPP-ACP) which has a desensitizing action when applied to tooth surfaces. The application leaves a film of varnish on tooth and this may allow visual control and verification. MI Vamish is packed in unit dose and can be applied on teeth with a disposable brush.
Here's an analysis of the provided text regarding the acceptance criteria and study for the MI Varnish device, structured to answer your specific questions.
Acceptance Criteria and Device Performance Study for MI Varnish
Based on the provided 510(k) summary (K102808), the device MI Varnish is a fluoride varnish intended for desensitizing action when applied to tooth surfaces. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing direct clinical efficacy against predefined acceptance criteria for a novel device. Therefore, the "acceptance criteria" here are primarily around demonstrating comparable physical and chemical properties to legally marketed predicate devices, and the "study" is a summary of physical tests.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by demonstrating similarity to predicate devices. The reported device performance is presented as a comparison against these predicates.
| Parameter | Acceptance Criteria (Implied by Predicate Devices) | MI Varnish Reported Performance |
|---|---|---|
| pH | Similar to Duraflor (6.8) and Vanish Varnish (6.4) | 6.6 |
| Consistency (mm) | Similar to Duraflor (40±1) and Vanish Varnish (26±1) | 39±2 |
| Total Fluoride (wt %) | Similar to Duraflor (2.2±0.1) and Vanish Varnish (2.6±0.1) | 2.4±0.1 |
| Chemical Composition | Similar to Duraflor and Vanish Varnish (with specific exceptions for Recaldent, Hydrogenated rosin, and Diethylene glycol monoethyl ether, which are addressed in substantial equivalence argument) | Contains 5% Sodium Fluoride, CPP-ACP, Hydrogenated rosin, Diethylene glycol monoethyl ether. |
| Mode of Action | Substantially equivalent to predicate devices | Yes (stated as substantially equivalent) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for the individual physical tests (pH, consistency, total fluoride). It provides mean values with standard deviations (e.g., 39(2) for consistency), which implies that multiple measurements were taken for each parameter.
- Test Set Sample Size: Not explicitly stated, but implied to be multiple measurements for each physical property.
- Data Provenance: The tests were conducted "According to GC Corporation R&D test methods." The manufacturing origin of the device, GC America Inc. (Alsip, IL, USA), implies the tests were likely performed in a controlled R&D environment associated with the submitter. The document does not specify a country of origin for the data beyond that. The data is retrospective, as it refers to tests performed prior to the 510(k) submission date.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. The "ground truth" for the physical and chemical properties is established by direct measurement using specified test methods, not by expert consensus or interpretation against a test set. There were no human readers involved in evaluating the performance metrics provided.
4. Adjudication Method for the Test Set
Not applicable. The performance is based on direct physical and chemical measurements rather than requiring expert 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 is not a diagnostic imaging or AI device. It's a dental material (fluoride varnish), and the submission does not involve an MRMC study or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a dental material, not a software or AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance characteristics presented (pH, consistency, total fluoride) is based on instrumental and analytical measurements according to established R&D test methods. For the overall substantial equivalence claim, the ground truth is established by comparing the device's characteristics and intended use to those of legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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