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Provides rapid and continual relief from tooth hypersensitivity-dueto cold, heat, acids, sweets, or contact through its action of the occlusion of dentin tubules.

Oralief™ Therapy for Sensitive Teeth incorporates NovaMin® as its active ingredient. The unique brushing regimen and NovaMin® -containing formulation provide rapid and continual relief from tooth sensitivity. NovaMin® (calcium sodium phosphosilicate) is composed of elements that occur naturally in the body (Ca, Na, Si, P, and O). When exposed to an aqueous environment, NovaMin® rapidly releases mineral-building ions, allowing it to relieve from sensitivity by physically occluding dentin tubules. Within a short period of time, essentially all of the NovaMin® reacts to form a mineral layer which is chemically and structurally similar to natural tooth mineral.

The provided document describes the FDA 510(k) premarket notification for Oralief™ Therapy for Sensitive Teeth. This product is a dentifrice (toothpaste) containing NovaMin® as its active ingredient, intended to provide relief from tooth hypersensitivity by occluding dentin tubules.

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Acceptance Criteria and Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of a predefined threshold for statistical metrics (e.g., sensitivity, specificity). Instead, the acceptance criterion for the device seems to be demonstrated efficacy in reducing tooth hypersensitivity compared to a placebo, and substantial equivalence to a legally marketed predicate device (Butler GUM® Prophylaxis Paste with NovaMin®).

The reported device performance is based on the clinical study described.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test set sample size: 20 patients were enrolled (10 in the NovaMin® group, 10 in the placebo group). A total of 48 sensitive teeth were measured in the NovaMin® group and 42 teeth in the placebo group.
   • Data provenance: The study was conducted at the Dental School of the University of Bologna, Italy. It was a prospective, double-blinded, two-arm parallel group study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The "ground truth" here is the patient's subjective experience of pain/hypersensitivity, measured using a Visual Analogue Scale (VAS). This is patient-reported, not expert-established in the traditional sense of diagnostic imaging.
   • The study protocol was approved by the Ethics Committee at the Dental School of the University of Bologna, Italy, implying expert oversight of the study design and ethical conduct. However, experts did not "establish ground truth" for individual patient responses.

3. Adjudication method for the test set:

   • Not applicable in the context of this study. The primary endpoint (VAS score) is a patient-reported outcome. There was no independent adjudication of patient responses. Measures included a metered air blast and cold water, which are objective stimuli, but the response (VAS score) is subjective.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This device is a toothpaste for sensitive teeth, not an AI-assisted diagnostic tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a therapeutic product, not an algorithm. Its performance is evaluated through its direct effect on patients.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for efficacy was primarily patient-reported outcomes data (Visual Analogue Scale - VAS scores) in response to standardized stimuli (metered air blast and cold water).
   • Additionally, in vitro studies demonstrated tubule occlusion, supporting the mechanism of action.

7. The sample size for the training set:

   • Not applicable. This is a clinical trial for a therapeutic device, not a machine learning model. Therefore, there is no "training set" in that context. The "training" here refers to the development and formulation of the product.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set in the machine learning sense. The development of the product would have involved extensive R&D, chemical analysis, in vitro testing, and potentially pre-clinical animal studies, but not a "ground truth" derived from patient data in a training set.

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