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For fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations and implant supported restorations, using a dental CAD / CAM system.

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This document is a 510(k) clearance letter from the FDA for a dental material (Shofu Block HC Hard), not an AI/ML device. Therefore, the requested information about acceptance criteria and studies proving the device meets them, particularly concerning AI/ML performance metrics, ground truth, sample sizes, and expert adjudication, is not applicable to this document.

The document discusses the regulatory clearance process for a tooth shade resin material under the name "Shofu Block HC Hard" and confirms its substantial equivalence to predicate devices. It outlines general regulatory requirements for medical devices but does not include any performance data or study details that would typically be associated with AI/ML device evaluations.

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For fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations, and implant crowns and bridges by dental labs and manufacturers using a dental CAD/CAM system.

Not Found

This document is a 510(k) premarket notification from the FDA regarding the "SHOFU BLOCK HC" device, which is a tooth shade resin material for dental restorations. This document is a regulatory approval, not a scientific study report.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not available in the provided text.

The document primarily focuses on the regulatory determination of substantial equivalence to a predicate device, allowing the device to be marketed. It does not contain the detailed technical performance data or study methodology that would typically be found in a clinical or scientific study report.

Ask a specific question about this device