(295 days)
Prevent Seal is used by dental profesionnals primarily in young children :
- . To fill and seal pit and fissure depressions (faults in the enamel) of teeth to prevent cavities :
- . Covering layer or " initial layer " in the fabrication of esthetically demanding composite restorations ; and
- . For repairs of composite restorations (in particular filling of voids, leveling out of porosities and minor chips).
Prevent Seal is a fluoride releasing, white, light-cured acrylate resin. Not manufactured with Bisphenol A.
Here's the analysis of the provided text regarding the acceptance criteria and study for the Prevent Seal device, formatted as requested:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not Explicitly Stated, Inferred from Performance Data) | Reported Device Performance |
|---|---|
| Flexural Strength (MPa) | 250 |
| Compressive Strength (MPa) | 160 |
| Shear Bond Strength to Etched Enamel (MPa) | 35 |
| Light Curing Time @ 23°C (sec) | 20 |
| Sensitivity to Ambient Light @ 22°C (sec) | 75 |
| Film Thickness (µm) | 10 |
| Radiopacity | Yes |
| Wavelength (nm) | 465 |
| Intensity of the light source (mW/sqcm) | 600 |
| Shade | White |
Note: The document lists "Summary of Performance Testing" which includes these metrics and their corresponding values. It does not explicitly state "acceptance criteria" with specific thresholds that the device had to meet. The provided values are the reported performance of the device based on the laboratory testing. This submission appears to rely on demonstrating performance comparable to predicate devices rather than meeting pre-defined specific numerical acceptance criteria.
Regarding the study that proves the device meets the acceptance criteria, based on the provided text, the following information is available:
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not specified in the provided text.
- Data provenance: "laboratory results". No specific country of origin is mentioned, but the submitter is based in France and the contact person in Canada. The testing explicitly states "laboratory results", implying prospective testing for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not specified. The performance testing appears to be objective, quantitative laboratory measurements of physical and mechanical properties, not subjective expert evaluation requiring ground truth establishment through consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. The reported performance metrics are results of laboratory tests (e.g., strength, curing time) and do not involve human adjudication for a test set.
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 comparative effectiveness study was not done. The device is a pit and fissure sealant, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device (a sealant material), not an algorithm or AI system. The performance documented is of the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective laboratory measurements: The "ground truth" for the reported performance metrics (Flexural Strength, Compressive Strength, etc.) is the direct measurement obtained from standardized laboratory tests. There is no human-interpreted "ground truth" in the traditional sense for these material properties.
8. The sample size for the training set:
- Not applicable. This device is not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI model, so there is no training set or associated ground truth.
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.