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For the management of sensitive teeth. Provides relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact. Desensitizes teeth for lasting relief.

Colgate® Desensitizing Mouthwash (CDMW) is an oral rinse. The components of CDMW physically form a thin film that acts like a seal, thereby physically restricting fluid movement through the dentin tubules and preventing external stimuli from triggering a pain response.

This document, K140481, describes the submission for Colgate® Desensitizing Mouthwash (CDMW). The primary study proving the device meets its acceptance criteria is an in-vitro hydraulic conductance study.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the in-vitro hydraulic conductance study. It is an in-vitro study, meaning it was conducted in a controlled environment outside of a living organism. Therefore, terms like "country of origin of the data" or "retrospective or prospective" are not applicable in the same way they would be for human clinical trials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. Given it's an in-vitro study, expert involvement would likely be in the design and interpretation of the experiment, rather than establishing "ground truth" for a test set in the clinical sense.

4. Adjudication Method for the Test Set

This information is not applicable as the study described is in-vitro and does not involve human readers interpreting results that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The described study is an in-vitro hydraulic conductance study, not a human reader study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a mouthwash, not an algorithm or a software device. The described study evaluates the physical mechanism of action of the mouthwash.

7. The Type of Ground Truth Used

For the in-vitro hydraulic conductance study, the "ground truth" would be the objective measurement of dentinal fluid flow and the physical observation of film formation and sealing within the controlled laboratory setting. It is based on direct measurement and physical observation of the product's mechanism of action.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning or AI-based device that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this type of device and study.

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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.

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.

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