(127 days)
IPS Empress Direct Color: Individualized characterization of direct and lab-fabricated composite resin restorations; masking of discolored tooth structure; characterization of chairside CAD/CAM veneers.
IPS Empress Direct Opaque: Masking exposed metal surfaces when repairing defective ceramic and composite veneers intraorally; Masking of discolored tooth structure.
Not Found
This FDA submission pertains to a dental device (IPS Empress® Direct Color and IPS Empress® Direct Opaque), which is a tooth shade resin material. These types of devices do not typically involve AI/ML components or require the detailed performance studies described in your request (e.g., MRMC, standalone algorithm performance, ground truth establishment by experts for AI evaluation).
Therefore, I cannot provide the requested information because the provided document does not discuss:
- Acceptance criteria and reported device performance in the context of AI/ML
- Sample sizes for test sets or training sets for an AI algorithm
- Data provenance for AI training/testing
- Number of experts or their qualifications for establishing ground truth for AI
- Adjudication methods for AI test sets
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth used for AI development/evaluation
The document is a 510(k) clearance letter for a dental material, establishing its substantial equivalence to predicate devices based on its intended use and general controls provisions. It does not involve any AI/ML components, and thus, the detailed AI-centric performance criteria and study descriptions you've requested are not applicable to this particular device.
§ 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.