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510(k) Data Aggregation
(8 days)
This device is intended for use as a dental cement. RelyX™ Luting Plus Automix (Lexus-2) is indicated for Luting:
- Luting porcelain fused to metal crowns and bridges to tooth structure, amalgam, composite or glass ionomer core build ups;
- Luting metal inlays, onlays or crowns;
- Luting pre-fabricated and cast post cementation
- Luting orthodontic appliances
- Luting crowns made with all-alumina or all zirconia cores such as Procera® AllCeram
3M™ ESPE™ RelyX™ Luting Plus Automix (Lexus-2) is a radiopaque, fluoride-releasing, resinmodified glass ionomer luting cement. It is self-curing with an option for tack light curing of excess cement. RelyX Luting Plus Automix (Lexus-2) consists of a base (Paste A) and catalyst (Paste B) packaged in an automix (dual barrel) syringe. The dual barrel syringe dispenses paste A and Paste B. The cement is available in a white shade.
The provided text describes the acceptance criteria and a study demonstrating that the device, RelyX™ Luting Plus Automix, meets these criteria.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are established by comparing the performance of the new device (RelyX™ Luting Plus Automix, referred to as Lexus 2) against a legally marketed predicate device (3M™ ESPE™ RelyX™ Luting Plus Cement, K022476). The reported device performance is indicated by "pass" for all tested properties, signifying that Lexus 2 met or exceeded the design specifications, which are implicitly acceptable as they are compared to a predicate device.
| Properties | Method | Lexus 2 Design Specification | Lexus2 Ave and Predicate (K022476) Performance |
|---|---|---|---|
| Flexural strength (FS) (MPa) | ISO 9917-2 | ≥ 10 MPa | pass |
| Radio-opacity (mm of Al) | ISO 9917-2 | ≥1.0mm of Al | pass |
| Adhesion to dentin (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to enamel (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to Metal (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to Lava™ (MPa) zirconia | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to composites | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to amalgam | 3M ESPE internal | ≥2MPa | pass |
| Adhesion to Titanium (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Adhesion to Lithium disilicate (MPa) | 3M ESPE internal | ≥2 MPa | pass |
| Fluoride release (µg F/g) at 90 days | 3M ESPE internal | ≥500 | pass |
| Film thickness (microns) | ISO 9917-2 | ≤ 25 | pass |
| Work time (s) | 3M ESPE internal | ≥ 90s | pass |
| Set time (s) | 3M ESPE internal | <480s | pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each individual bench test. It mentions that the data is obtained from "Bench Test Data Comparison," and the methods used for certain tests are "ISO 9917-2" and "3M ESPE internal" methods.
The data provenance is from internal testing conducted by 3M ESPE. There is no mention of country of origin for the data or whether it was retrospective or prospective, but it implies a controlled laboratory environment designed to compare the new device to the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This study concerns the physical and chemical properties of a dental cement, evaluated through standardized bench tests and internal laboratory methods, rather than expert interpretation of medical images or patient data. Therefore, there is no "ground truth" established by experts in the context of medical diagnosis.
4. Adjudication method for the test set
Not applicable. This study does not involve human interpretation or subjective assessment that would require an adjudication method. The evaluations are based on predefined quantifiable metrics and established testing protocols.
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. This is not a study involving human readers or AI assistance. It is a bench test comparison of the physical and chemical properties of a dental cement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI-based device. It is a dental cement, and its performance is assessed through laboratory bench tests.
7. The type of ground truth used
The "ground truth" in this context is established by:
- International Standards: ISO 9917-2 for Flexural Strength, Radio-opacity, and Film Thickness. These standards define the methods and potentially acceptable ranges for these properties.
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is the performance of the legally marketed predicate device (RelyX™ Luting Plus Cement, K022476). The new device is considered substantially equivalent if its performance (as measured by design specifications and actual test results) is comparable to or better than the predicate's and meets the specified criteria.
- Internal 3M ESPE Specifications: For properties like adhesion, fluoride release, work time, and set time, "3M ESPE internal" methods and "Design Specifications" are used, implying established internal criteria and methods by the manufacturer.
8. The sample size for the training set
Not applicable. This is a bench test study for a physical product, not a machine learning model, so there is no training set in the AI/ML sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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