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Priming of CAD/CAM hybrid ceramic restorations

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The provided document is a 510(k) premarket notification letter from the FDA regarding a dental product named "Hc Primer." It pertains to the regulatory clearance of a material (Resin Tooth Bonding Agent) and not a medical device that would involve AI, imaging, or diagnostics, which are typically the subjects of studies with "acceptance criteria" and "device performance" in the context of AI/ML devices.

Therefore, the document does not contain any information about:

• Acceptance criteria for an AI/ML device
• Reported device performance in terms of metrics like sensitivity, specificity, or accuracy
• Sample sizes for test or training sets
• Data provenance
• Ground truth establishment or number/qualification of experts
• Adjudication methods
• Multi-reader multi-case (MRMC) studies or effect sizes
• Standalone algorithm performance

The questions posed are relevant to the regulatory submission of AI/ML-powered medical devices, specifically those involving diagnostic or prognostic capabilities based on image analysis or other data types. This document is a clearance for a chemical substance used in dental procedures.

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