(187 days)
To relieve dental hypersensitivity.
Senzzzzz Away is an oxalate tooth desensitizing agent intended for over-the-counter-use. The combination of tubule occlusion and reduction in nerve excitability shown with oxalate formulations is responsible for the reduction in dentinal hypersensitivity to cold, hot and sweets. Senzzzzz Away is a one-part, opaque gel for single use.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting studies for the Senzzzzz Away device:
Important Note: The provided 510(k) summary for Senzzzzz Away (K120176) is for a dental cavity varnish. The questions in your prompt are largely tailored towards an AI/Software as a Medical Device (SaMD) product, which often involves metrics like sensitivity, specificity, MRMC studies, and ground truth established by experts. As such, many of the requested fields cannot be directly addressed from this type of regulatory submission for a physical medical device. I will extract all available information and explicitly state when a question cannot be answered from the provided text.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from study goals) | Reported Device Performance (from "Effectiveness Study") |
|---|---|
| Reduction in dental hypersensitivity | Demonstrated reduction in sensitivity (over 6 months) |
| Ease of use for over-the-counter application | Patient use determined to be appropriate for OTC purchase |
| Tubule occlusion | Seals and occludes dentinal tubules |
Explanation of Inferred Criteria: The 510(k) summary doesn't explicitly state quantitative acceptance criteria or thresholds (e.g., "sensitivity must reduce by X%"). Instead, it describes the purpose of the studies, from which we can infer the criteria for success. The "effectiveness study" aimed to "demonstrate the reduction in sensitivity," implying that a statistically significant reduction in hypersensitivity was the acceptance criterion for effectiveness. The "consumer ease-of-use study" aimed to "ensure that patient use of the product was appropriate for over-the-counter purchase," indicating that the device needed to be readily usable and safe for consumers. The in vitro testing ("Scanning electron microscopy") aimed to show tubule occlusion and sealing, a key mechanism of action.
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size:
- Effectiveness Study: Not explicitly stated. The summary only mentions "A six month effectiveness study was performed."
- Consumer Ease-of-Use Study: Not explicitly stated. The summary only mentions "A consumer ease-of-use study conducted."
- Biocompatibility/SEM Study: Not explicitly stated for number of extracted teeth.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not specified in the provided text. The effectiveness and consumer studies would typically be prospective, but this is not explicitly stated. The biocompatibility/SEM analysis used "extracted teeth," which would be retrospective in terms of tooth origin, but the analysis itself is contemporary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. For a dental desensitizer, "ground truth" often refers to clinical endpoints like patient-reported sensitivity or objective measurements of sensitivity. Expert consensus in the traditional sense of image analysis or diagnostic interpretation is not relevant here. The evaluation of effectiveness would typically rely on patient-reported outcomes (e.g., VAS scores for pain) and potentially some objective stimuli (cold, air blast, etc.) assessed by dental professionals, but the number and qualifications of such assessors are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. This concept is generally associated with diagnostic studies where multiple readers interpret cases and their discrepancies are resolved. For a dental desensitizer's effectiveness study, adjudication methods like 2+1 or 3+1 are not typically used. The data would likely be collected directly from subjects and/or through objective measurements by trained clinical staff.
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:
- No. An MRMC study is specific to diagnostic imaging interpretation, often involving AI assistance. This device is a treatment for hypersensitivity. The "effectiveness study" was a clinical trial to demonstrate the device's therapeutic effect, not an MRMC study comparing human reader performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical product (cavity varnish) applied by a human, and it does not involve any algorithms or AI for standalone performance evaluation in the way a SaMD would.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Outcomes Data (patient-reported hypersensitivity) and Physical/Biological Evidence (tubule occlusion). The "effectiveness study" would have used methods to assess the reduction in dental hypersensitivity, likely through patient-reported pain scales (e.g., Visual Analog Scale (VAS) or similar) in response to stimuli (cold, hot, sweet, air blast), which are a form of outcomes data. The scanning electron microscopy (SEM) analysis provided direct biological evidence (ground truth) of tubule occlusion, confirming a key mechanism of action.
8. The sample size for the training set:
- Not applicable / Not provided. This device does not use machine learning or AI that requires a "training set." The studies performed were clinical efficacy and consumer usability studies.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no training set for an algorithm, this question is not relevant to the described device.
§ 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.