(5 days)
- Anterior and posterior restorations
- Repair of restorations and prostheses
- Core-build up
- Direct laminate veneer
Not Found
The provided text is a standard FDA 510(k) clearance letter for a dental resin material, "Beautifil II." This document confirms that the device has been cleared for marketing based on its substantial equivalence to previously marketed devices.
*Crucially, this document does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-based medical device. The product, "Beautifil II," is a physical dental material (tooth shade resin), not an AI/ML software device.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and reported device performance
- Sample sizes for test sets or data provenance
- Number of experts or their qualifications for ground truth establishment
- Adjudication methods
- MRMC study details or effect sizes
- Standalone algorithm performance
- Type of ground truth used
- Training set sample size or how its ground truth was established
The 510(k) clearance process for a material like Beautifil II typically involves different types of testing (e.g., biocompatibility, physical properties, mechanical strength, chemical composition) to demonstrate safety and effectiveness, rather than a clinical study with image-based ground truth and human reader performance evaluation as would be done for an AI/ML diagnostic aid.
If you have a document describing the testing for an AI/ML device, please provide that, and I would be happy to analyze it against your request.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.