(90 days)
Nexus RMGI is intended for use as a permanent dental cement. It is indicated for the following indirect restorations:
- Cementation of metal-based inlays, onlays, crowns and bridges
- Cementation of resin inlays, onlays, crowns and bridges
- Cementation of all ceramic inlays
- Cementation of high strength (zirconia based) all ceramic crowns and bridges
- Cementation of metal, ceramic and fiber posts
Nexus™ RMGI is a radiopaque resin-modified glass ionomer luting cement offered in a paste/paste/paste formulation that provides an option for tack light-curing of excess cement. This paster formalation that problems of a catalyst packaged in dual-barrel syringes. The base and catalyst are dispensed from the dual-barrel syringe through automix tips.
The provided text describes a 510(k) premarket notification for a dental cement (Nexus RMGI) and compares its performance characteristics to a predicate device (RelyX Luting Plus Automix). It does not describe an AI/ML device or a study involving human readers or AI assistance. Therefore, information regarding acceptance criteria, study details, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML devices cannot be extracted from this document.
However, I can extract the acceptance criteria and reported device performance for the Nexus RMGI dental cement based on the physical and chemical properties presented in the "Summary of Technological Characteristics" table.
Here's the table of acceptance criteria (represented by the predicate device's performance as a benchmark for substantial equivalence) and the reported device performance for Nexus RMGI:
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Predicate: RelyX Luting Plus Automix) | Reported Device Performance (Nexus RMGI) |
|---|---|---|
| Gel Time (Working Time) @ 22.5°C | 3'20" | 1'55" |
| Set Time @ 22.5°C | 6'45" | 3'15" |
| Set Time @ 37.0°C | 4'45" | 2'20" |
| Flexural Strength (MPa) | 20.7 | 36.7 |
| Compressive Strength (MPa) | 103 | 154 |
| Translucency (%) | 16.1 | 39.1 |
| Film Thickness (μm) | 16 | 9 |
| Consistency of mixed paste (cm) | 3.2 | 2.9 |
| Radiopacity (% Al) | 150 | 217 |
| Solubility (7 days, %) | 0.94 | 0.28 |
| Cumulative Fluoride Release (1 week, ppm) | 41 | 25.7 |
| Cumulative Fluoride Release (4 week, ppm) | 81.9 | 48.1 |
| Shear Bond Strength (Dentin, MPa) | 15.6 | 20.2 |
| Shear Bond Strength (Enamel, MPa) | 10.5 | 16.2 |
| Shear Bond Strength (Rexillium III, MPa) | 12.0 | 26.3 |
| Shear Bond Strength (Gold Alloy, MPa) | 11.8 | 16.8 |
| Shear Bond Strength (Zirconia, MPa) | 13.8 | 17.5 |
| Shear Bond Strength (Porcelain with HF etch, MPa) | 14.3 | 23 |
| Shear Bond Strength (Composite, MPa) | 7.3 | 17.6 |
| Shear Bond Strength (Lithium Disilicate, MPa) | 14.9 | 17.7 |
| Shear Bond Strength (Alumina, MPa) | 13.1 | 14.9 |
| Shear Bond Strength (Titanium, MPa) | 13.4 | 25.2 |
| Post (lbs) | 34.8 | 53.9 |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes bench testing of material properties, not an AI/ML test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material property testing does not involve expert ground truth establishment in the way AI/ML studies do.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm. The performance described is for the dental cement itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance characteristics of the Nexus RMGI device is established through standardized laboratory bench testing methods (e.g., ISO 9917-2:2010 for flexural strength) and comparison to the predicate device's measured properties.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the non-clinical (bench) testing of a dental cement to establish substantial equivalence to a predicate device. It does not contain information relevant to AI/ML device performance or studies involving human-in-the-loop or standalone AI performance.
§ 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.