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BRILLIANT EverGlow Flow Universal and Translucent shades are suitable for:

• · Direct class V fillings (cervical caries, root erosion, wedge-shaped defects)
• · Fillings in the anterior tooth region (Class III and IV)
• · Small fillings of all cavity classes (not occlusion-bearing)
• · Blocking out of undercuts
• · Adhesive luting of indirect composite and ceramic restorations in as far as accuracy of fit and light permeability are given
• · Repairs of direct and indirect composite restorations
• · Preventive resin restorations
• · Cavity lining

BRILLIANT EverGlow Flow opaque shade is also suitable for:

• · Aesthetic corrections (e.g. deviations in chroma)
• · Masking of dark areas

BRILLIANT EverGlow Flow is a flowable radiopaque submicron hybrid composite and available in several shades that allows for high aesthetic restorations with a clear spectrum of shades. It is applied in the increment technique and available in 7 universal, 2 translucent and 3 opaque shades.

BRILLIANT EverGlow Flow is chemically characterized by its composition, which can be categorized in three groups based on their chemical and functional similarity: resin components (matrix monomers based on methacrylates), fillers, and additives. The largest part of BRILLIANT EverGlow Flow's composition is represented by fillers (>58% w/w), followed by resin components (30 days) with tissue/bone/dentin.

BRILLIANT EverGlow Flow is the supplemental flowable, radiopaque submicron hybrid material version of the universal composite BRILLIANT EverGlow. BRILLIANT EverGlow Flow is, due to its lower viscosity, considered an enhancement of BRILLIANT EverGlow for applications with non-easily accessible areas in the oral cavity (e.g. blocking out of undercuts) and/or extended fissure-sealing. BRILLIANT EverGlow Flow combines a low viscous consistency with high stability and thixotropy, allowing a controlled and comfortable application. BRILLIANT EverGlow Flow is available in different shades and gradations of translucency. BRILLIANT EverGlow Flow is delivered with two application needle sizes (standard size [Ø 0.8mm] and fine size [Ø 0.4mm]). The fine size needle is to improve the accessory range and to allow an application with higher precision.

This document describes a 510(k) premarket notification for a dental material, BRILLIANT EverGlow Flow, and its substantial equivalence to a predicate device, BRILLIANT EverGlow. Dental materials are not medical devices in the typical sense of AI, so there is no AI acceptance criteria or study that proves AI meets the acceptance criteria.

However, I can extract information regarding the product's acceptance criteria and the study conducted to prove it meets those criteria:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Reasoning: The acceptance criteria are implicitly established by demonstrating substantial equivalence to the predicate device. The subject device's performance values fall within ranges that are considered acceptable for dental composite materials as per relevant ISO standards and comparison to the predicate device. For example, while the flexural strength is lower and water sorption/solubility are higher for the new device compared to the predicate, these differences are presented in the context of showing clinical equivalence and compliance with established standards like ISO 4049:2009 for dental polymer-based restorative materials.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each non-clinical test (e.g., flexural strength, compressive strength). The data provenance is Coltène/Whaledent AG, Switzerland, a prospective study is implied as part of the new device's development and testing for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a non-clinical assessment of material properties, not an evaluation of an AI algorithm based on human expert ground truth.

4. Adjudication method for the test set

Not applicable. This is a non-clinical assessment of material properties.

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 a non-clinical assessment of material properties. There is no AI component mentioned in the document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a non-clinical assessment of material properties. There is no AI component mentioned in the document.

7. The type of ground truth used

The "ground truth" for the non-clinical performance data is based on:

• Physical and mechanical property measurements: Direct laboratory measurements using standardized testing methods (e.g., ISO 4049:2009 for dental polymer-based restorative materials).
• Biocompatibility: Adherence to established biological evaluation standards (ISO 10993-1:2018).
• Risk Management: Application of risk management principles (EN ISO 14971:2012).

8. The sample size for the training set

Not applicable. There is no AI algorithm and therefore no training set.

9. How the ground truth for the training set was established

Not applicable. There is no AI algorithm and therefore no training set.

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BRILLIANT EverGlow Bleach (BL), A1/B1, A2/B2, A3/D3, A3,5/B3, C2/C3, A4/C4 are indicated for:

• Direct filling of class I, II, III, IV and V cavities
• Cementation and repair of composite and ceramic restorations (e.g. COMPONEER)

BRILLIANT EverGlow Translucent (Trans) and Bleach Translucent (BL Trans) are indicated for:

• Shape and color corrections to enhance the individual esthetics
• Reconstruction of incisal edges
• Cementation and repair of composite and ceramic restorations (e.g. COMPONEER)

Not Found

This document is a 510(k) clearance letter from the FDA for a dental material called BRILLIANT EverGlow. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The information provided describes:

• The FDA's decision that the BRILLIANT EverGlow material is "substantially equivalent" to legally marketed predicate devices.
• The regulation number and name for the material (21 CFR 872.3690, Tooth shade resin material).
• The intended uses for the BRILLIANT EverGlow material, which are direct filling of various classes of cavities, as well as cementation and repair of composite and ceramic restorations.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving a device meets acceptance criteria based on the provided text, as it concerns a dental material's substantial equivalence to existing products, not a device study with the requested metrics.

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