(54 days)
- Sealing/filling of pits and fissures as well as small cavities
- Sealing/facing of damaged enamel surfaces
- Anchorage of orthodontic appliances
- Sealing of composites or cement fillings
- Restoration of small defects in composites and amalgam fillings
- Sealing of deciduous teeth
Not Found
This FDA document is a 510(k) clearance letter for the "Admira Seal" device, a pit and fissure sealant. It does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device.
The document grants market clearance based on substantial equivalence to legally marketed predicate devices, a regulatory pathway that typically relies on demonstrating that the new device is as safe and effective as a legally marketed device that is not subject to PMA. This usually involves comparing device characteristics (e.g., materials, design, intended use) and performance data from internal testing or literature reviews, rather than clinical studies with detailed acceptance criteria and expert-adjudicated ground truth as would be expected for AI/ML performance evaluation.
Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria, study details, sample sizes, expert qualifications, ground truth, etc.) because this information is not present in the provided text. The document simply states that the device is substantially equivalent and thus cleared for market.
§ 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.