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PrepQuick has shown to be an effective means for selective removal of smear layer prior to cementation, e.g., glass ionomers and polycarboxylate cements or restoratives.

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This document is a 510(k) clearance letter from the FDA for a device called "PrepQuick." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter is a regulatory approval, not a scientific study report.

Therefore, I cannot provide the requested information. The sections of your request remain unanswered based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the document.
2. Sample size used for the test set and the data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
4. Adjudication method: Not provided in the document.
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 relevant, as this is not an AI/imaging device and no human reader study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant, as this is not an algorithm/software device.
7. The type of ground truth used: Not provided in the document.
8. The sample size for the training set: Not provided in the document.
9. How the ground truth for the training set was established: Not provided in the document.

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