(351 days)
- Sealing / filling of pits and fissures
- Sealing / facing of damaged enamel surfaces
- Covering of predilection sites, e.g., within the scope of orthodontic treatments
- Sealing of composite or glass ionomer fillings (profective layer against moisture)
- Sealing of deciduous teeth
- Extended fissure sealing
Not Found
This looks like a 510(k) summary for a pit and fissure sealant device, not an AI/ML medical device. Therefore, the information typically requested for AI/ML device studies (such as acceptance criteria for algorithm performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not available in this document.
The document mainly focuses on the regulatory aspects of the device, establishing its substantial equivalence to a predicate device.
To address your request, I will indicate "Not applicable" or "Not provided in the document" for the categories that do not apply to this type of device submission.
Here's the information based on the provided text:
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1. A table of acceptance criteria and the reported device performance: Not applicable. This document is a 510(k) clearance letter for a physical dental device (Control Seal pit and fissure sealant) and does not contain performance metrics or acceptance criteria in the way an AI/ML device would. The "performance" being evaluated here is primarily related to its chemical and physical properties and its substantial equivalence to existing devices, which is not detailed in this letter.
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2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the document. This would typically be found in a separate study report, often for clinical trials, which is not included in this regulatory letter.
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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 provided in the document. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert consensus on image interpretation) is not relevant for this type of device clearance.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided in the document.
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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: Not applicable. This is not an AI/ML device.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided in the document. The "ground truth" for a dental sealant would typically be its efficacy in preventing caries, retention rates, or physical properties (e.g., bond strength, wear resistance), none of which are detailed in this 510(k) clearance letter.
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8. The sample size for the training set: Not applicable. This is not an AI/ML device.
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9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
In summary, the provided document is a regulatory approval letter (510(k) clearance) for a non-AI medical device. It confirms that the device, Control Seal, manufactured by VOCO GmbH, is substantially equivalent to legally marketed predicate devices for its intended uses as a pit and fissure sealant and conditioner. It does not contain the detailed study information relevant to AI/ML device performance that you requested.
§ 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.