(118 days)
- 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.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.