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510(k) Data Aggregation
(55 days)
élan - 2 is a light-curable, dental restorative material containing a fluoride releasing agent which is designed to be used as a filling material for Class III and Class V restorations. Additional functions include: Repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in low-stress bearing areas, pit and fissure sealant, base/cavity liner and blockout of undercuts.
The device is a light cured, radiopaque flowable compomer dental restorative combining the desirable properties of a flowable composite resin and a glass ionomer: good mechanical strength and wear resistance, excellent esthetics, easy handling and placement, and long-term fluoride release. This unique flowable compomer utilizes a special acidic aromatic resin containing multi-methacrylate functional groups, which, upon curing, results in an extremely strong and highly wear resistant crosslinked matrix system. It is reinforced with a reactive fluoroaluminosilicate filler (approximately 60%) and fumed silica to provide a flowable, non-slumping restorative material.
The provided text is a 510(k) summary for a dental restorative material, not a description of a medical device that uses AI or sophisticated algorithms requiring acceptance criteria validation studies as typically conceived in a modern regulatory context. Therefore, much of the requested information cannot be extracted from this document.
The document discusses the substantial equivalence of a "light-curable dental restorative material" (élan-2) to existing legally marketed devices. It focuses on the physical and chemical properties and intended use of the material, not on a device that generates diagnostic output or relies on complex software performance.
Here's a breakdown of what can be inferred or directly stated from the provided text, and where gaps exist due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
This document does not specify "acceptance criteria" in the context of a statistical performance study for an AI/algorithm-driven device. It discusses the device's properties in relation to substantial equivalence to a predicate device.
| Acceptance Criteria (Not explicitly stated for performance, but implied for equivalence) | Reported Device Performance (Implied from description) |
|---|---|
| Functions in a manner similar to predicate device (Vivadent Ets., Compoglass Flow) | Light-cured, radiopaque, flowable compomer dental restorative. |
| Intended for the same use as predicate device | Restoration of Class III and Class V cavities, repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in low-stress bearing areas, lining cavities, sealing pits and fissures, block-out of undercuts. |
| Good mechanical strength and wear resistance (implied desirable properties) | Utilizes a special acidic aromatic resin containing multi-methacrylate functional groups, resulting in an extremely strong and highly wear-resistant crosslinked matrix system. Reinforced with reactive fluoroaluminosilicate filler and fumed silica. |
| Excellent esthetics (implied desirable properties) | Listed as a desirable property. |
| Easy handling and placement (implied desirable properties) | Listed as a desirable property. |
| Long-term fluoride release (implied desirable properties) | Listed as a desirable property. |
2. Sample sized used for the test set and the data provenance
Not applicable. This device is a material, not a software/AI system that uses a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method 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. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental material.
7. The type of ground truth used
Not applicable. The "ground truth" for a dental restorative material would be its physical, chemical, and biological properties, and clinical performance, evaluated through established ISO/ADA standards and clinical trials (which are not detailed here, as it's a 510(k) summary focused on substantial equivalence to a predicate).
8. The sample size for the training set
Not applicable. There is no training set for a machine learning model.
9. How the ground truth for the training set was established
Not applicable.
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