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Indication for use:

• Temporary anterior and posterior crowns;
• Implant and abutment supported prosthetics;
• Partial, complete and hybrid denture prosthetics (base and teeth).

Not Found

This FDA 510(k) clearance letter pertains to dental materials (Temporary Crown And Bridge Resin) and does not contain any information about an AI/ML medical device, its acceptance criteria, or the study that proves the device meets those criteria.

Therefore, I cannot extract the requested information regarding:

• Acceptance Criteria Table: There is no mention of performance metrics like sensitivity, specificity, or AUC.
• Sample Size and Data Provenance: No details about test sets, training sets, countries of origin, or retrospective/prospective studies.
• Expert Ground Truth: No information about the number or qualifications of experts or how ground truth was established.
• Adjudication Method: No mention of 2+1, 3+1, or any other adjudication process.
• MRMC Study: No indication of a multi-reader, multi-case comparative effectiveness study or related effect sizes.
• Standalone Performance: No data on the algorithm's performance without human intervention.
• Type of Ground Truth: No mention of pathology, outcomes data, or expert consensus.
• Training Set Sample Size and Ground Truth Establishment: No information provided.

The document is solely a regulatory approval for a physical dental product, not a software or AI/ML device requiring performance evaluation against clinical ground truth.

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