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1. Direct Posterior Restorations (including occlusal surfaces)
2. Replacement of individual cusps
3. Base-liner under direct restorations.
4. Restorations of deciduous teeth
5. Class V restorations (cervical caries, root erosion, wedge-shaped defects)

Not Found

I am sorry, but the provided text is an FDA clearance letter for a dental resin material, "Renamel Bulkfill". It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding:

• Acceptance criteria for a device performance study.
• Details of a study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• How ground truth for a training set was established.

This document is solely a regulatory clearance for a physical dental product (filling material), not a software or AI-driven diagnostic device that would typically undergo the types of studies you are asking about.

Ask a specific question about this device