(132 days)
Premier Sealant, a prescription only medical device used for prophylactic sealing of pits and fissures. It may also be used for micro-restorative or "initial layer" of composite restorations.
Not Found
I am sorry, but the provided text from the FDA 510(k) premarket notification for the "Premier Sealant" does not contain any information about a medical device that uses artificial intelligence (AI) or machine learning.
The document is a standard FDA clearance letter for a dental pit and fissure sealant, which is a physical product, not a software-based diagnostic or assistive device that would involve acceptance criteria for AI performance.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size.
- How ground truth for the training set was established.
This information is simply not present in the provided text as the device in question is a traditional dental material, not an AI-powered diagnostic tool.
§ 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.