(2 days)
APAPRO Desensitizer is a fluoride-free paste that is indicated to provide relief from tooth hypersensitivity resulting from cold, heat, acids, sweets, or contact, through its action of dentin tubule occlusion.
APAPRO Desensitizer is a fluoride-free tooth desensitizing paste that utilizes hydroxyapatite, the main component of teeth, as its active ingredient to relieve tooth sensitivity by physically occluding exposed dentin tubules. The hydroxyapatite deposited into dentin tubules by APAPRO Desensitizer then acts as a template for the further deposition of large amounts of calcium and phosphate ions, promoting crystal integrity and growth.
The provided text describes a 510(k) premarket notification for a dental device, Apapro Desensitizer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria related to a new device's performance metrics like sensitivity and specificity.
Therefore, the information requested about acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within the provided text.
The submission for Apapro Desensitizer (K220419) primarily relies on non-clinical tests comparing its mechanism of action and effectiveness in occluding dentin tubules to a predicate device, Oralief™ Therapy for Sensitive Teeth (K040858).
Here's what can be extracted based on your request, even if it highlights what's missing:
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics (e.g., specific percentages for sensitivity, specificity, or accuracy) in the context of a clinical trial. The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to the predicate device based on technological characteristics, intended use, indications for use, and a similar mechanism of action.
- Reported Device Performance: The primary reported "performance" is that "APAPRO Desensitizer was shown to be as effective as the NovaMin® found in the predicate device in occluding dentin tubules."
Trait Acceptance Criteria (Implicit for Substantial Equivalence) Reported Device Performance (APAPRO Desensitizer) Indications for Use Must be equivalent to the predicate device: Provides relief from tooth hypersensitivity resulting from cold, heat, acids, sweets, or contact, through its action of dentin tubule occlusion. Provides relief from tooth hypersensitivity resulting from cold, heat, acids, sweets, or contact, through its action of dentin tubule occlusion. (Equivalent) Intended Use Must be equivalent to the predicate device: For dental hypersensitivity relief, prescribed and applied by dental physicians for use in the Adult Population. For dental hypersensitivity relief, prescribed and applied by dental physicians for use in the Adult Population. (Equivalent) Mechanism of Action Must be equivalent or substantially similar to the predicate device: Formation of a hydroxyapatite layer to physically occlude dentin tubules. Directly occludes dentin tubules by depositing a crystalline calcium phosphate layer (hydroxyapatite) on the tooth surface. (Equivalent in outcome, though different in active ingredient origin. Details in "Active Ingredient" and "Material Produced to Occlude Tubules"). Performance (Dentin Tubule Occlusion) Must demonstrate comparable effectiveness in occluding dentin tubules to the predicate device. SEM micrographs showed similar occlusion of dentin tubules as NovaMin-treated samples. "APAPRO Desensitizer was shown to be as effective as the NovaMin® found in the predicate device in occluding dentin tubules." Biocompatibility Must be biocompatible and non-antigenic, conforming to ISO 10993 standards. Biocompatible, non-antigenic. Biocompatibility tests in accordance with ISO 10993 performed, and a biological risk assessment indicates no hazardous effects when used as directed in the Adult Population. (Equivalent) -
Sample sizes used for the test set and the data provenance:
- Sample Size: Not specified. The "test set" in this context refers to dentin samples used for SEM imaging, not human subjects in a clinical trial.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study was a "non-clinical test" involving dentin samples.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was a non-clinical in vitro test using SEM micrographs, not a study requiring expert clinical interpretation for ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This was an in vitro comparison of SEM micrographs, not a human reader study.
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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 not an AI-based diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a material-based dental desensitizer, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical test, the "ground truth" for demonstrating dentin tubule occlusion was established through Scanning Electron Microscopy (SEM) micrographs to visually confirm the physical occlusion by the deposited hydroxyapatite layer. This is an objective laboratory measure.
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The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this device is not an AI algorithm.
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How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned.
§ 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.