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510(k) Data Aggregation
(246 days)
HAPI Seal
Pit and fissure sealant
HAPI Seal is a light-cured, fluoride containing, resin-based pit & fissure sealant designed for sealing the enamel pits and fissures of teeth.
The provided text is a 510(k) summary for a dental device, HAPI Seal, and does not describe a study involving an AI algorithm or human readers. Therefore, several of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable.
Here's the information that can be extracted from the document:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria / Requirement | Reported Device Performance |
|---|---|
| Depth of Cure | HAPI Seal meets the requirements of ISO 6874:2015. |
| Flexural Strength | HAPI Seal meets the requirements of ISO 4049:2009 for Flexural Strength. |
| Shear Bond Strength (Modified ISO 29022) | HAPI Seal is equivalent to the predicate. |
| Light Curability (Cure time) | HAPI Seal is equivalent to the predicate. |
| Ambient Light Sensitivity | HAPI Seal is equivalent to the predicate. |
| Flexural Modulus (ANSI/ADA Spec No. 27) | HAPI Seal is equivalent to the predicate. |
| Cumulative Fluoride Release | HAPI Seal is equivalent to the predicate. |
| Compressive Strength (ANSI/ADA Spec No. 27) | HAPI Seal is equivalent to the predicate. |
| Surface Hardness (Barcol-Colman 934-1) | HAPI Seal is equivalent to the predicate. |
| Shrinkage (Volumetric) | HAPI Seal is equivalent to the predicate. |
| Biocompatibility (Cytotoxicity, Oral Toxicity) | HAPI Seal was not toxic in the oral toxicity test (10 mice, 14 days). An evaluation using ISO 7405:2008 and ISO 10993-1 was conducted. |
2. Sample size used for the test set and the data provenance:
- Oral Toxicity Study: 10 mice were used for a 14-day study.
- Other performance tests: The document mentions that HAPI Seal "meets" or is "equivalent" to the predicate for various physical/mechanical properties based on specific ISO or ANSI/ADA standards. However, it does not explicitly state the sample sizes used for these tests. The data provenance is not specified (e.g., country of origin, retrospective or prospective), but these are laboratory tests done to regulatory standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the studies described are laboratory performance and biocompatibility tests, not studies requiring expert interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable.
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:
This information is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the physical/mechanical properties and biocompatibility was established through adherence to recognized international and national standards (e.g., ISO 6874:2015, ISO 4049:2009, ISO 29022:2013, ANSI/ADA Spec No. 27, ISO 7405:2008, ISO 10993-1).
8. The sample size for the training set:
This information is not applicable as this is not an AI algorithm study.
9. How the ground truth for the training set was established:
This information is not applicable.
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