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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.

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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.

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