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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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• · For direct bonding of composite resin to dentin and enamel.
• · For direct bonding of composite resin to dentin and enamel in the co-cured technique.
• · For direct bonding of composite resin to GI self cure or GI light cure base base base on and enamel in the "sandwich" technique.
• · For · sealing to hypersensitive cervical areas and root surfaces of teeth.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the Riva Bond LC device. The document is a 510(k) premarket notification letter from the FDA, confirming the substantial equivalence of the Riva Bond LC to a legally marketed predicate device. It defines the indications for use but does not include details about performance studies or acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

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Pit and fissure sealing. Root/tooth surface protection and hypersensitivity prevention. Temporary restorations in non load-bearing applications, temporary endodontic sealing.

Not Found

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding the Riva Protect device, classifying it and permitting its marketing. It does not include details on performance testing or clinical studies.

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Minimal Class I, II and III restorations. Class V restorations, deciduous teeth and geriatric restorations, core build-ups, root surface restorations, used as a base or liner, pit and fissure sealant, semi-permanent fillings.

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This is a letter from the FDA regarding the 510(k) premarket notification for the Riva Light Cure dental cement. It states the device is substantially equivalent to legally marketed predicate devices.

The document does not contain acceptance criteria for the device's performance, nor does it describe any study. Therefore, I cannot provide the requested information.

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Direct bonding of light-cured composite and compomer materials, dentin sealing, direct bonding of light-cured composite to ceramics, composite, metals and amalgam.

Not Found

This is a letter from the FDA to a medical device manufacturer, indicating that their device, "Adhesive 1," has been found substantially equivalent to a legally marketed predicate device. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the regulatory clearance for marketing the device.

Therefore, I cannot extract the requested information regarding the acceptance criteria and the study that proves the device meets them from the provided text.

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Minimal Class 1 & 2 restorations, deciduous teeth restorations, core build-ups, restorations where opacity is desirable, root surface restorations, Class 5 restorations in nonaesthetic situations, base material for composite restorations, pit and fissure sealant, and semi-permanent fillings.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA for a dental cement called Riva Silver. It primarily addresses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

This document focuses on regulatory approval based on substantial equivalence and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics. Therefore, I cannot provide the requested information.

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..."

To answer your questions, I would need a document that details the specific performance studies conducted for Riva Silver, including acceptance criteria, study design, results, and ground truth establishment. This 510(k) clearance letter does not include such details.

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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.

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Silver based alloy dental restorative used in all classes of restorations.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental alloy. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Specifically:

1. Acceptance criteria and reported device performance: Not present. This document is a regulatory clearance, not a performance report.
2. Sample size, data provenance: Not present.
3. Number of experts and qualifications: Not present.
4. Adjudication method: Not present.
5. MRMC comparative effectiveness study: Not present.
6. Standalone performance study: Not present.
7. Type of ground truth: Not present.
8. Sample size for training set: Not present.
9. How ground truth for training set was established: Not present.

The document discusses the regulatory determination of substantial equivalence for the "Benco Admix" dental restorative, indicating it's an amalgam alloy used in all classes of restorations. It refers to general controls and existing regulations but does not detail any performance studies or their associated acceptance criteria.

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Silver based alloy dental restorative used in all classes of restorations.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental restorative material, "Benco Spherical." This document confirms the device's substantial equivalence to a predicate device and permits its marketing. It does not contain information about acceptance criteria, device performance studies, or details relevant to the specific questions posed (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details). These types of details are typically found in the 510(k) submission itself, which is not provided here, rather than in the FDA's decision letter.

Therefore, I cannot provide the requested information based solely on the provided text. The document is a regulatory approval letter, not a technical report on device performance.

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Polymerization of light curing dental materials with photo initiator for the wavelength range 440 – 480 nm.

Suitable for light curing composite restorative materials, anterior composites, posterior composites, bonding agents, pit and fissure sealants, orthodontic adhesive and flowable composites.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental curing light (Radii), outlining its general information, regulation, and indications for use. It does not include details on acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot generate the table or the detailed description of a study as requested.

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