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• Cementation of metal free or porcelain fused to metal inlays, onlays, bridges and crowns.
• Cementation of stainless steel crowns.
• Cementation of posts and screws.
• Attachment of metal orthodontic bands.
• Base or liner.

Not Found

The provided text is a 510(k) summary for the Riva Luting Plus dental cement. It is a regulatory document from the FDA, not a scientific study describing device performance against acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

However, I can extract the following:

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

This document does not contain a table of acceptance criteria or reported device performance. It is a letter granting substantial equivalence based on a comparison to predicate devices, not an evaluation of clinical performance against specific metrics.

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

Not applicable. This document does not describe a performance study for the Riva Luting Plus.

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. This document does not describe a performance study for the Riva Luting Plus.

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

Not applicable. This document does not describe a performance study for the Riva Luting Plus.

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. Riva Luting Plus is a dental cement, not an AI-assisted diagnostic device.

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

Not applicable. Riva Luting Plus is a dental cement, not an algorithm.

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

Not applicable. This document does not describe a performance study for the Riva Luting Plus.

8. The sample size for the training set:

Not applicable. This document does not describe a training set as it pertains to a machine learning model.

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

Not applicable. This document does not describe a training set as it pertains to a machine learning model.

In summary, the provided document is a regulatory approval letter for a dental cement based on substantial equivalence, not a study detailing performance against acceptance criteria. Therefore, it does not contain the information requested in your prompt.

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Suitable for cementation of crowns, bridges, inlays and orthodontic bands.

Also suitable for sealing interface between restoration and tooth and base / liner in deep restorations.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Southern Dental Industries, Incorporated for a device named "Riva Luting," a dental cement. This document is a regulatory approval letter and does not contain the acceptance criteria or a study describing the device's performance against such criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the approval is based on substantial equivalence to an already approved predicate device, not on a new study demonstrating performance against specific acceptance criteria. The document does not provide details about any studies or acceptance criteria beyond the general indications for use.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies from the provided text.

Ask a specific question about this device