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Clinical indications

• Restoration of caries defects
• Reconstruction of lost tooth substance due to attrition, abrasion, erosion
• Restoration of tooth fractures
• Correction of anatomical malformation

Cosmetic indications

• Optimization of old composite restorations
• Extending incisors
• Correction of malpositioned teeth
• Cosmetic corrections for tooth discoloration or incorrect shading
• Closure of diastema

The subject device BRILLIANT COMPONEER is a polymerized, highly filled, submicron hybrid composite enamel shell(s) for direct veneering. It simplifies the direct restoration of front teeth and premolars without having to model the basic shape of the top enamel layer. The thin, anatomical composite shells are available in different shades and shapes allowing a natural, high aesthetic restoration.

The provided text describes a medical device called "BRILLIANT COMPONEER," which is a tooth shade resin material. The FDA 510(k) premarket notification K191385 outlines the substantial equivalence of this device to a predicate device, COMPONEER.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for performance are derived from the predicate device's performance and the general standard for this type of material (ISO 4049). The device is deemed substantially equivalent if its performance is comparable.

Note: While some values are different, the submission asserts substantial equivalence based on extensive performance and biocompatibility testing according to applicable standards.

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 performance test. It mentions that extensive testing was performed. The data provenance is stated as testing performed by Coltène/Whaledent AG in Switzerland. The studies are retrospective in the sense that they are laboratory bench tests conducted to demonstrate compliance with standards and comparison to a predicate, not prospective clinical trials.

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

This information is not provided in the document. The ground truth for the performance characteristics is established by objective measurements based on international standards (e.g., ISO 4049). For biocompatibility, it's based on objective assays and assessments according to ISO 10993 and ISO 7405. There is no indication of human expert interpretation being required to establish the "ground truth" for the test set results.

4. Adjudication method for the test set

This information is not applicable as the document describes non-clinical performance testing (bench tests and biocompatibility tests), which do not typically involve human adjudication in the way clinical studies or expert consensus for image interpretation would. The results are based on objective measurements and adherence to specified procedures within the standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a dental material, not an AI-assisted diagnostic tool or an imaging device that would typically involve human readers or AI assistance.

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

Not applicable. This device is a physical dental material, not an algorithm or software. The performance tests are standalone in the sense that they measure the material's inherent properties, without human interpretation in the loop.

7. The type of ground truth used

The ground truth used for the performance tests consists of objective measurements against established international standards. For chemical and physical properties (e.g., compressive strength, water sorption), the ground truth is the measured value itself, compared to the predicate and standard requirements. For biocompatibility, the truth is whether the material elicits a specific biological response based on standardized assays.

8. The sample size for the training set

Not applicable. This device is a physical dental material, not a machine learning model. Therefore, there is no "training set."

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

Not applicable. As there is no training set for a machine learning model, this question is not relevant to the described device.

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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 Crios is indicated for:

• Crowns, inlays, onlays and veneers
• Implant-supported crowns.

BRILLIANT Crios is a radiopaque composite material composed of crosslinked methacrylate based polymerized monomers and dental glass fillers. The subject device is made available in block forms of different sizes, shades and translucencies for the fabrication of permanent tooth restorations such as inlays, onlays, crowns and veneers using CAD/CAM milling equipment.

This document is a 510(k) summary for a dental restorative material called BRILLIANT Crios. It focuses on demonstrating substantial equivalence to a predicate device, CERASMART™, rather than providing detailed acceptance criteria and study results for a diagnostic AI device.

Therefore, the provided text does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving device performance for an AI/diagnostic device.

The document describes the physical and mechanical properties of the BRILLIANT Crios material and compares them to a predicate device, CERASMART™, and a reference device, SYNERGY®. It also mentions that the company conducted performance and biocompatibility testing.

Here's what can be extracted, though it doesn't directly answer your specific questions in the context of an AI/diagnostic device:

1. A table of acceptance criteria and the reported device performance:

The document provides a comparison table (Table 5-1) for physical and mechanical properties. While not explicitly "acceptance criteria" in the AI sense, these are performance metrics for a dental material.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a material science study, not a clinical study on a test set for an AI device.

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 is a material science study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a material science study.

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 material science study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a material science study.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" here would be laboratory measurements of physical and mechanical properties.

8. The sample size for the training set:
Not applicable. This is a material science study, not an AI training process.

9. How the ground truth for the training set was established:
Not applicable. This is a material science study.

Summary of what the document does indicate about the study:

• Study Type: Non-clinical (benchtop) performance and biocompatibility testing of a dental restorative material.
• Standards Used: ISO 4049 (Polymer-based Restorative Materials), ISO 7405 (Biocompatibility of medical devices in dentistry), ISO 10993-1 (Biological Evaluation of Medical Devices).
• Performance Metrics: Flexural strength, flexural modulus, compressive strength, and biocompatibility.
• Conclusion: The subject device (BRILLIANT Crios) "passed all required testing" and was determined to be "as safe and effective as the predicate device" based on these tests.

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DuoCem is indicated for:

• permanent cementing of crowns, inlays, onlays (ceramic, metal, composite)
• permanent cementing of root posts of all types

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental cement called DuoCem. It determines substantial equivalence for the device based on its indications for use.

Crucially, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. This document is a regulatory approval letter, not a scientific study report.

Therefore, I cannot answer the requested questions with the given input.

To answer those questions, I would need a different document, such as:

• A clinical study report
• A performance testing report
• A premarket notification (510(k)) summary that includes detailed performance data.

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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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One Coat 7 Universal is indicated for:

• bonding in adhesive restoration techniques
• adhesive attachment of composite materials and compomers on enamel and dentin
• adhesive attachment of ceramic and composite restorations on enamel and dentine
• composite material on ceramic, composite material, metal and amalgam
• dentine sealing

Not Found

The provided document is a 510(k) clearance letter from the FDA for a dental resin bonding agent, "One Coat 7 Universal." This type of document declares substantial equivalence to a predicate device and does not contain information about the acceptance criteria and study data typical for software or AI/ML-driven medical devices.

Therefore, I cannot provide the requested information as the document does not describe:

• Acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
• Any study data proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone performance.
• Type of ground truth used.
• How ground truth was established for training data.

This letter solely confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.

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Fill-Up! is indicated for - direct restoration of class I and II cavities - cavity lining - first layer for class I and II cavities - core build-ups

Not Found

The provided document is a 510(k) clearance letter from the FDA for a dental material (Fill-Up!), not a study describing the acceptance criteria and performance of a device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth from this document.

The letter merely states that the device is substantially equivalent to legally marketed predicate devices for the indicated uses. It does not contain any performance data, study designs, or statistical analyses typically found in a clinical or performance study report.

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SoloCem is indicated for

• permanent cementation of root posts of all types
• permanent cementation of crowns, bridges, inlays, onlays
• permanent cementation of implant abutments

Not Found

I am sorry, but the provided text is a 510(k) premarket notification approval letter from the FDA for a dental cement called SoloCem. This document focuses on the regulatory approval process and does not contain detailed information about specific acceptance criteria for a device's performance, nor does it describe a study proving the device meets particular criteria.

Therefore, I cannot extract the requested information such as a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

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• -restoration therapy for caries
• -optimisation of old restorations
• -tooth fractures
• -extending incisors
• -malpositioned teeth
• -tooth discoloration, incorrect shading
• -anatomical malformation
• -diasteme
• -attrition, abrasion, erosion
• -cosmetic correction

COMPONEER are polymerised, radio-opaque composite shells

This document is a 510(k) premarket notification decision letter from the FDA regarding a dental device called COMPONEER. It does not contain information about the acceptance criteria or a study proving the device meets said criteria for an AI/ML powered medical device.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory determination based on comparing the new device to existing ones, rather than through a study with specified acceptance criteria for algorithm performance.

Therefore, I cannot extract the requested information from this document.

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TempoSIL 2 is indicated for

• temporary cementation of provisional restorations
• temporary cementation of provisional restorations on implant abutments
• temporary cementation of final crown and bridges
• temporary cementation of final crowns and bridges on implant abutments

Not Found

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to Coltene/Whaledent AG for a dental cement called "Temposil 2". It states that the device is substantially equivalent to legally marketed predicate devices. The letter primarily focuses on regulatory compliance, outlining the requirements for marketing the device under the Federal Food, Drug, and Cosmetic Act.

The document includes:

• The trade/device name: Temposil 2
• Regulation Number and Name: 872.3275, Dental Cement
• Regulatory Class: II
• Product Code: EMA
• Date of FDA review and receipt of the notification.
• A confirmation of substantial equivalence.
• A list of general controls and additional controls the device may be subject to.
• Contact information for various FDA offices.
• The Indications for Use statement for TempoSIL 2.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set or data provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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