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Grandio Core Dual Cure:

• core build ups of vital and non-vital teeth
• Luting of root posts

Not Found

The provided text is an FDA 510(k) clearance letter for a dental device called "Grandio Core Dual Cure." This document primarily focuses on regulatory approval and does not contain information about acceptance criteria, clinical study design, or performance metrics.

Therefore, I cannot extract the requested information regarding:

• Acceptance Criteria and Reported Device Performance: This information is not present.
• Sample size used for the test set and data provenance: No test set or study data is described.
• Number of experts used to establish the ground truth for the test set and qualifications: No ground truth establishment is described.
• Adjudication method for the test set: Not applicable as no test set is described.
• Multi reader multi case (MRMC) comparative effectiveness study: No such study is mentioned.
• Standalone (algorithm only without human-in-the-loop performance): This is a dental material, not an AI algorithm.
• Type of ground truth used: Not applicable as no study is described.
• Sample size for the training set: Not applicable as no training set for an AI algorithm is involved.
• How the ground truth for the training set was established: Not applicable.

The document discusses the regulatory review of a dental material's "substantial equivalence" to legally marketed predicate devices, based on its indications for use. It's a regulatory clearance, not a scientific study report.

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