(293 days)
For the management of sensitive teeth. Provides rapid relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact. Rapid Desensitizer
Not Found
The provided text is for a traditional 510(k) notification for a medical device (Colgate® Desensitizing Dental Cream) seeking to switch from prescription to over-the-counter use. This document primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting detailed study results with acceptance criteria in the manner typically found for novel diagnostic AI/ML devices. Therefore, much of the requested information regarding AI/ML device performance metrics, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance is not directly applicable or available in this submission.
However, I can extract the available information as it pertains to the device's performance and the general nature of the studies conducted.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in quantitative terms. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and adherence to relevant ISO standards. The reported performance is qualitative.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Demonstrated physical occlusion of dentin tubules | In vitro studies show: CDDC demonstrates physical occlusion of the dentin tubules, creating a protective barrier that prevents external stimuli from reaching the nerves that reside in the dentin pulp. |
| Provision of instant sensitivity relief | Clinical studies show: instant sensitivity relief occurs with direct application. |
| Safety and effectiveness comparable to predicate devices | Device is safe and as effective as the predicate devices. |
| Performance of intended use as well as or better than predicate devices | Device performs its intended use as well as or better than the legally marketed predicate devices. |
| Compliance with ISO standards | CDDC complies with ISO 11609, ISO 10993-1:2003(E), and ISO 7405:2008 (E). |
2. Sample size used for the test set and the data provenance
The document mentions "in vitro studies" and "clinical studies" but does not specify the sample sizes used for these studies. The data provenance (e.g., country of origin, retrospective/prospective) is also not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The studies mentioned are likely efficacy and safety studies on human subjects, not studies requiring expert interpretation of outputs for establishing ground truth in the context of diagnostic AI/ML.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not typically relevant for this type of device and submission.
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
An MRMC study is not mentioned and is not applicable to this type of medical device (dentifrice). The device itself is not an AI/ML diagnostic tool but a dental cream.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a dental cream, not an algorithm, and does not have a "standalone" or "human-in-the-loop" performance in the AI/ML context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "clinical studies," the ground truth would likely be patient-reported outcomes of sensitivity relief and potentially objective measurements of dentin tubule occlusion in the in vitro studies. The specific methodologies for establishing these are not detailed.
8. The sample size for the training set
This information is not provided and is not applicable to this type of device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable to this type of device.
Summary of Device and Study Context:
This 510(k) submission is for a dental cream, not a digital health or AI/ML device. The "performance data" section briefly mentions in vitro and clinical studies to demonstrate the product's mechanism of action (physical occlusion of dentin tubules) and its ability to provide instant sensitivity relief. The primary focus of the 510(k) is to demonstrate substantial equivalence to existing predicate devices and compliance with established performance standards (ISO standards), rather than to provide detailed clinical trial data with specific statistical acceptance criteria and AI/ML-specific performance metrics.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.