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• [1] Surface treatment of prosthetic restorations made of ceramic, hybrid ceramics, composite resin or metal
• [2] Intraoral repairs of fractured restorations made of ceramics, hybrid ceramics, composite resin or metal

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The provided text is a US FDA 510(k) clearance letter for the device "CLEARFIL CERAMIC PRIMER PLUS". This document confirms that the device has been found substantially equivalent to predicate devices. However, this type of document does not contain the information requested in your bullet points regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The FDA 510(k) summary (which is a separate document typically published alongside the clearance letter) or the submission itself would contain details about the performance data. Without access to those documents, I cannot provide the requested information.

The clearance letter focuses on:

• Confirming substantial equivalence.
• Listing the device name, regulation number, and product code.
• Outlining regulatory compliance responsibilities for the manufacturer.
• Specifying the "Indications for Use" for the device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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