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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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1. Surface treatment of porcelain, ceramics, hybrid ceramics or composite resin
2. Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics, hybrid ceramics or composite resin

CLEARFIL CERAMIC PRIMER is a silane-coupling agent that provides an enhanced adhesive surface to porcelain, ceramics, hybrid ceramics or composite resin.

The provided text describes a 510(k) submission for the "CLEARFIL CERAMIC PRIMER" device, which is a silane-coupling agent. However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for a detailed AI/ML device study.

Instead, the core of this 510(k) submission is to demonstrate substantial equivalence to existing predicate devices. This means the manufacturer is asserting that the new device is as safe and effective as devices already on the market, rather than meeting specific quantifiable performance benchmarks like sensitivity/specificity for a diagnostic AI.

Here's an analysis based on the provided text, highlighting what is and is not present:

Key Takeaways from the document:

• The device is a silane-coupling agent intended to enhance the adhesive surface for dental materials (porcelain, ceramics, hybrid ceramics, composite resin) and for intraoral repairs.
• Substantial Equivalence: The primary method for proving the device's acceptability is through its similarity to predicate devices.
• Performance Data: The document mentions "Tensile bond strength tests on the applicant device in comparison to the predicate devices" as evidence of effectiveness/performance. This is the only direct performance study mentioned, but no specific acceptance criteria or detailed results are provided.

Analysis against the Requested Information:

Since the provided document is a 510(k) summary focused on substantial equivalence rather than a detailed performance study with explicit acceptance criteria for an AI/ML device, much of the requested information (especially regarding AI-specific details like sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable or not present.

Here's a breakdown based on the categories you requested, with responses tailored to the information available:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size: Not specified. The document only mentions "Tensile bond strength tests" without details on the number of samples, replicates, or cases.
   • Data Provenance: Not specified. The manufacturer is KURARAY MEDICAL INC., located in Japan. The tests were likely conducted internally or by a contracted lab, but the location and whether the data is retrospective or prospective are not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not Applicable / Not Present: This device is a chemical primer, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" here would be the measured physical properties (e.g., tensile bond strength), not an expert consensus on an image or clinical case.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not Applicable / Not Present: As this is not an AI/ML diagnostic or interpretive device, adjudication methods for expert disagreement are irrelevant to the tensile bond strength testing mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • Not Applicable / Not Present: This is not an AI-assisted device. Therefore, no MRMC study or analysis of human reader improvement with AI assistance was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not Applicable / Not Present: This is not an AI algorithm; it's a dental material.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Ground Truth Type: For the "Tensile bond strength tests," the "ground truth" would be the quantifiable physical measurement of the bond strength itself, obtained through laboratory testing. This is not subjective expert consensus, pathology, or outcomes data.

8. The sample size for the training set

   • Not Applicable / Not Present: This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

   • Not Applicable / Not Present: No training set exists for this type of device.

In summary: The provided document is a 510(k) summary for substantial equivalence of a dental primer, not a detailed technical report for an AI/ML device. Therefore, the information regarding specific acceptance criteria, detailed study design, sample sizes for training/test sets, expert involvement, and AI-specific performance metrics is largely absent or not applicable. The basis for acceptance is a qualitative assertion of "as well as or better than" predicate devices concerning chemical ingredients and tensile bond strength performance.

Ask a specific question about this device