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• Fabrication of temporary crowns, bridges, inlays, onlays and veneers;
• Fabrication of long-lasting temporary restorations;
• Rebasing of prefabricated temporary crowns made of composite, polycarbonate or metal.

Self-curing composite that is highly efficient for the production of temporary pieces for indirect dental procedures such as inlays, onlays, crowns, veneers and bridges. The product consists of a base paste and a catalyzing paste stored in a cartridge and in a double-body syringe, from where they are automatically dispensed in the correct proportion (1:1), providing practical clinical procedures with reduced chances of errors or incorporated bubbles.

The provided text is a 510(k) summary for the device PrimmaArt, a temporary crown and bridge resin. It describes the device, its indications for use, comparison with a predicate device (Structur 3), and non-clinical testing results.

However, the document does not contain information regarding a study involving human readers, ground truth establishment, sample sizes for test or training sets, or expert qualifications for AI/ML device performance analysis. The acceptance criteria and "device performance" in the context of this document refer to physical and chemical properties of the dental resin, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and study details related to an AI/ML device per the input prompt's structure. The device described, PrimmaArt, is a material, not a software or AI/ML device.

However, I can extract the acceptance criteria and reported device performance for the dental resin based on the provided tables:

1. Table of Acceptance Criteria and Reported Device Performance (for PrimmaArt dental resin):

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

• This information is not applicable as the study involves material testing, not an AI/ML algorithm or dataset. The tests are performed on samples of the PrimmaArt resin. The data provenance is DentsCare LTDA, Brazil, as the manufacturer.

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

• Not applicable as this is not an AI/ML device. Ground truth, in this context, refers to the adherence of the material's properties to international standards (e.g., ISO) and internal design inputs.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable as this is not an AI/ML device evaluated by human readers. The assessment is based on direct measurement against established material performance 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:

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device. The performance tests are for the material itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical testing of the dental resin, the "ground truth" or reference for acceptance is defined by recognized international standards (e.g., ISO 7491, ISO 10477, ISO 4049) and the device's internal design input specifications.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. There is no concept of a "training set" for a dental resin material in this context.

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

• Not applicable as this is not an AI/ML device.

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• Base under direct restorations;
• Small, non-occlusal stress-bearing class I restorations according to minimally invasive filling therapy;
• Pit and fissure sealant;
• Tunnel-type preparation;
• Repair of small enamel defects;
• Bonding of tooth fragments;
• Composite resin repairs;
• Non-carious cervical lesions.

Vittra APS Unique Flow is a light-curing composite of low viscosity, with a single shade for all dental shades, suitable for minimally invasive cavity preparations, base/liner and minor repairs. The composite is radiopaque, with a total inorganic filler content of 58% to 62% by weight (56% to 60% by volume) and an average particle size between 1.7 and 1.9 micrometers. It does not contain Bis-GMA or Bis-EMA in its formulation, following the current trend of Bisphenol A (BPA) free products. The composite has the APS as a photoinitiator system, an acronym for Advanced Polymerization System, which consists of a combination of different photoinitiators that interact with each other, amplifying the curing capacity of the light emitted by the light-curing units. Added to different materials, the system provides several advantages. APS confers great polymerization power, which allows a greater degree of conversion, obtaining superior stability to ambient light and providing longer working time during restorations.

The provided document is a 510(k) summary for the device "Vittra APS Unique Flow", a tooth shade resin material. It describes the device, its intended use, comparison with a predicate device, and non-clinical testing results to demonstrate substantial equivalence.

Here's the requested information synthesized from the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific non-clinical test. The tests were conducted according to recognized standards like ISO 4049, ISO 7491, and ISO 10993. The data provenance is internal testing performed by Dentscare LTDA (Brazil), as indicated by the company information and submission details. It is a retrospective study based on laboratory testing of the device.

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

The document mentions "observers" attested to the color stability and mimicry. However, it does not specify the number of experts, their qualifications, or how they established ground truth for these subjective assessments. For other objective tests (e.g., flexural resistance, depth of cure), the ground truth is established by the specified ISO standards and measured values.

4. Adjudication method for the test set

Not applicable. The tests are primarily objective measurements against established international standards (e.g., ISO 4049) or subjective assessments (color stability, mimicry) by unnamed "observers". There is no mention of a formal adjudication method for these non-clinical tests.

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 device is a dental material (tooth shade resin), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

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; it does not involve an algorithm or AI.

7. The type of ground truth used

For most tests, the ground truth is defined by the numerical specifications and methodologies outlined in recognized international standards such as ISO 4049, ISO 7491, and those within the ISO 10993 series. For color stability and mimicry, it appears to be a form of expert observation/assessment by unnamed "observers" against acceptance criteria of "no more than a small color change/difference".

8. The sample size for the training set

Not applicable. This device is a physical product and does not involve machine learning algorithms that require a training set.

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

Not applicable, as no training set is relevant for this type of device.

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The Vittra APS Unique composite is indicated for use in permanent and deciduous teeth:

• Direct restorations in anterior and posterior teeth (Classes I, II, III, IV, V and VI).

Light-curing composite for all dental shades for use in anterior and posterior restorations, recommended for all classes of cavities. The composite is radiopaque, with total inorganic load of 72% to 80% in weight (52% to 60% in volume), average particles between 0.8 and 0.9 microns. It does not contain Bis-GMA nor Bis-EMA in its formula, following the present trend of products not made with Bisphenol A (BPA).
The composite has APS as its photoinitiation system. APS stands for Advanced Polymerization System, and consists of a combination of different photoinitiators that interact among themselves amplifying the curing capacity of the light emitted by the light-curing device.

The provided text describes the regulatory filing for the Dentscare Vittra APS Unique dental composite, focusing on its substantial equivalence to a predicate device (Llis, Vittra APS). The document outlines performance criteria for both devices through non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each test (e.g., number of specimens for depth of cure, flexural strength). It mentions:

• For Sensitivity to ambient lighting and Color tone stability, "samples in triplicate" were read, and "All comparisons were carried out by observers with normal eyesight."
• For Radiopacity, "The average results obtained..." implies multiple measurements.
• For Accelerated Stability Studies, the test period was "274 days."

Data Provenance: The tests were "pre-clinical tests" performed by Dentscare Ltda, a Brazilian company. The data is retrospective for the purpose of this 510(k) submission, as it reports completed test results. The country of origin of the data is Brazil, where Dentscare Ltda is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• For Sensitivity to ambient lighting and Colour tone stability, "three observers with normal vision" were used for visual inspection. No further specific qualifications (e.g., "radiologist with 10 years of experience") are provided beyond "normal vision."

4. Adjudication Method for the Test Set

• For visual comparisons (Sensitivity to ambient lighting, Colour tone stability), the method appears to be a consensus or majority opinion among the three observers, as it states, "The observers did not attest any difference of color." There is no explicit "2+1" or "3+1" adjudication mentioned, but simply that the observers collectively confirmed no difference.
• For quantitative tests (Depth of Cure, Radiopacity, Flexural Strength, Water Sorption/Solubility), the ground truth is established by objective laboratory measurements against the ISO 4049 standard, not expert adjudication in the same sense as image interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a dental composite material, not an AI or imaging diagnostic device that would typically involve human readers.

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

No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is based on International Standards specifications, primarily ISO 4049. These standards define measurable physical and chemical properties (e.g., depth of cure, flexural strength, radiopacity) and objective criteria for visual assessments (e.g., requirements for observers' vision, test conditions for color stability).

8. The Sample Size for the Training Set

This information is not applicable as this is a physical dental composite material, not an AI model that requires a training set. The "training" for the device would be its development process and formulation, not a data-based training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above. The "ground truth" during the development (analogous to "training") of such a material would be its chemical composition, manufacturing process, and adherence to design specifications to meet the desired physical properties.

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Opallis (Sculptable version)

• The composite is suitable for use in permanent and deciduous teeth:
• Direct restorations in anterior and posterior teeth Classes I, II, III, IV, V and VI.
• Direct veneers with composites.
• Cementation of tooth fragments.
• Core build-ups.
• Teeth splinting.
• Diastema closing or reduction.
• Modification of teeth's shape (e.g .: conoid teeth).
• Porcelain/composite repairs.

Opallis Flow (Flowable version)

• Base/lining underneath direct restorations.
• Small, non-occlusal stress-bearing class I restorations according to minimally invasive filling therapy
• Pit and fissure sealant.
• Tunnel-type preparation.
• Repair of enamel defects.
• Bonding of tooth fragments.
• Repairs in composite resin.
• Non-carious cervical lesions.
• Planning of preparation walls.

Opallis is a, radiopaque, light-curing composite resin with fluorescent and opalescent properties. It is an aesthetic restorative material used for restorations of anterior and posterior teeth.

Opallis Flow is a light-curing composite resin used for the restoration of slightly invasive preparations, pit and fissure sealant, base/lining underneath direct restorations, in tunnel-type preparations, radiopaque lining of cavities, repairs of enamel defects, restorations of primary teeth, repairs in composite resin, bonding of tooth fragments, class I, III and V restorations, non-carious cervical lesions. Opallis Flow can be used separately or with Opallis composites.

The provided text describes the acceptance criteria and performance data for two dental composite resins, Opallis and Opallis Flow, to demonstrate their substantial equivalence to predicate devices for FDA 510(k) clearance.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance (Opallis and Opallis Flow):

All results > specified threshold. | Opaque shades: 2.97 mm
Non-opaque shades: 3.01 mm

All results > specified threshold. |
| Color tone stability | No more than a small change in color, as determined by visual inspection by three observers with normal vision in a D65 light chamber, comparing specimen on a diffuse white background against a gray background. (ISO 4049 and ISO 7491) | All comparisons carried out by three observers with normal eyesight; no color difference attested. | All comparisons carried out by three observers with normal eyesight; no color difference attested. |
| Radiopacity | Values found in specimens demonstrating they are radiolucent, typically between the second and third scale of the aluminum part. (ISO 4049) | 2.46 mm. Values found are between the second and third scale of the aluminum part. | 2.49 mm. Values found are between the second and third scale of the aluminum part. |
| Flexural Strength | ≥ 80 MPa (EN ISO 4049) | 93.38 MPa. All results > specified threshold. | 137.80 MPa. All results > specified threshold. |
| Water Sorption | Maximum of 40 µg/mm³ (ISO 4049) | 28.93 µg/mm³. Complies with specification. | 27.92 µg/mm³. Complies with specification. |
| Solubility | Maximum of 7.5 µg/mm³ (ISO 4049) | 5.53 µg/mm³. Complies with specification. | 5.46 µg/mm³. Complies with specification. |
| Shelf Life (Accelerated Stability) | Confirmed shelf-life based on accelerated degradation studies (e.g., 3 years at 30°C). | 3 years at 30°C confirmed based on 274 days test. | 3 years at 30°C confirmed based on 274 days test. |
| Shelf Life (Long-Term Stability) | Confirmed shelf-life based on physical and chemical characteristics during expected shelf life (e.g., 3 years at 30°C). | 3 years at 30°C confirmed based on 36 months test. | 3 years at 30°C confirmed based on 36 months test. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: The document does not explicitly state the specific numerical sample size (e.g., number of specimens tested for each physical property). It refers to "the samples" for various tests.
• Data Provenance: The tests are non-clinical and performed by the manufacturer, Dentscare LTDA, which is based in Joinville, Santa Catarina, Brazil. The studies appear to be prospective, laboratory-based tests comparing the manufactured devices against ISO standards.

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

• For the Color tone stability test: "three observers with normal eyesight, certified by a competent physician" were used for visual inspection. No further qualifications (e.g., years of experience, specific medical specialty) are provided beyond "normal vision" and "certified by a competent physician."
• For other physical property tests (e.g., flexural strength, depth of cure), the "ground truth" is established by adherence to International Standards (ISO 4049) rather than expert consensus on individual outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• For Color tone stability, it states: "All comparisons were carried out by three observers... They did not attest to any color difference in the samples analyzed." This implies a form of consensus or 3/3 agreement among these observers. There is no explicit mention of an adjudication process like "2+1" if there were disagreement, but the stated outcome implies unanimous agreement.
• For other tests, adherence to the numerical specifications of ISO standards serves as the "adjudication."

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 MRMC comparative effectiveness study was done. This device is a dental restorative material (composite resin), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• Not applicable. This is a physical dental material, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For physical and chemical properties, the ground truth is based on International Standards specifications (specifically ISO 4049) and objective measurements compared against these predefined ranges.
• For biocompatibility, the ground truth is established through laboratory in-vitro and in-vivo tests (e.g., cytotoxicity, sensitization, irritation, genotoxicity, implantation) conducted according to ISO 10993 standards. Additionally, the pre-existence of similar products on the market ("long term (10 years) the subject devices are in the market with no chronic toxicity reported") and comparison to predicates with more complex formulations (Vittra APS) informs the biocompatibility conclusions.
• For Color tone stability, a form of expert visual consensus (3 certified observers) is used against a control.

8. The sample size for the training set:

• Not applicable. This is a physical dental material. The "training" for such devices would be the manufacturing process development and quality control, not a data-driven training set in the AI sense.

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

• Not applicable, as there is no "training set" in the context of an AI/algorithm where ground truth is established. The manufacturing and material specifications are developed and validated against industry standards and internal quality controls.

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Orthocem: Cementation of metal, ceramic or polycarbonate brackets or tubes to enamel surface.
Ortho bite: The product is indicated for cementing orthodontic bands and is also suitable for temporary dental disocclusion during orthodontic treatment.

Orthocem is a light-curing orthodontic single syringe cement that promotes the union between ceramics or metal brackets to the enamel surface. It has a fluorescent substance that allows tracing the product when applying ultraviolet light, facilitating product's removal from teeth, after removing brackets.
Ortho Bite is a light-curing self-adhesive composite with self-levelling characteristics and surface hardness. Its composition includes dimethacrylate monomers, HEMA Phosphate, traditional Camphorquinone/DABE system as photoinitiator and silica as load particle. The combination of silica load fillers with the dimethacrylate monomer composition results in a viscosity that allows it to be handled and applied without running off the application area. The presence of HEMA Phosphate allows adhesion to the enamel surface, which is a known feature of composite cements indicated for bracket bonding. The thixotropy allows the product to have self-levelling capability, known as a shear thinning property that makes the composite settle correctly on the occlusal surface. The product is colored in order to facilitate its identification during application and removal.

The provided document is a 510(k) Premarket Notification from the FDA for two dental adhesive devices, "Orthocem" and "Ortho Bite". It details the equivalence to predicate devices based on non-clinical testing of material properties, not a study involving AI or human readers for diagnostic performance. Therefore, many of the questions related to AI-specific evaluation metrics, human expert involvement, and clinical study design (like MRMC, effect size, training/test sets for AI, and adjudication) are not applicable to this submission.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based only on the information available in the provided text:

Key Takeaway: This 510(k) submission focuses on demonstrating substantial equivalence of dental materials based on physical, chemical, and mechanical properties, not on AI-driven diagnostic performance or human reader studies. The "study" mentioned refers to non-clinical laboratory tests.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally derived from recognized international standards like ISO 4049, ISO 10993, and ISO 29022. The reported device performance is compared against these standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the numerical sample sizes for each non-clinical test (e.g., how many specimens were used for flexural strength tests). It refers to the tests performed "according to the table below" for performance studies.
• Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting on manufactured product samples, not on patient data. The manufacturer, DENTSCARE LTDA, is based in Brazil (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL). The tests generated prospective data (i.e., designed experiments to evaluate product properties).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This is not applicable as the "test set" consists of non-clinical material samples, not patient data requiring expert interpretation (e.g., radiology images). The ground truth is established by the physical and chemical properties of the materials themselves, measured by standardized laboratory methods.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., radiologist reads) in clinical studies. For physical material tests, results are objectively measured.

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 submission is for dental adhesive materials, not an AI-assisted diagnostic device. No MRMC study was performed, and human reader performance with or without AI assistance is not relevant to this device's evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a material, not an algorithm. Therefore, no standalone algorithm performance was assessed.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by physical, chemical, and mechanical measurements of the material properties according to recognized international standards (e.g., ISO 4049, ISO 29022, ISO 10993). This is typically performed through controlled laboratory testing.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in the context of demonstrating substantial equivalence for dental materials based on physical properties. The "training" for the device's formulation would occur during its research and development phase, but not as part of a formal "training set" for regulatory evaluation in the way AI models are trained.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set" in the context of this device's regulatory evaluation. The development of the dental adhesive formulation (the "training" of the product itself) would rely on material science principles and iterative laboratory testing to achieve desired properties, rather than a "ground truth" derived from patient data or expert consensus.

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Allcem Veneer APS is an adhesive luting of ceramic and composite restorations (fabricated at the chair-side or in the laboratory) with a low layer thickness (up to 1.5 mm) that enable the use of a purely light-curing technique due to their high translucency.

Allcem Veneer Try-in accessory is used to simulate the chromatic effect that will be provided when selected the ideal color of Allcem Veneer cement.

Allcem Veneer APS is a light-curing resin cement for adhesive cementation of no-prep or indirect veneers of up to 1.5mm of thickness, that do not have opaque infrastructure. The cement is presented as a single component (single svringe) and must be used according to the adhesive cementation technique (acid etching + adhesive).

APS is the acronym for Advanced Polymerization System, and it consists of a combination of different photo initiators that interact among each other amplifying the curing capacity of light emitted from light-curing units.

Presentation Form:

• syringe (2,5g) of Allcem Veneer APS cement in shade A1
• syringe (2,5q) of Allcem Veneer APS cement in shade A2
• syringe (2,5g) of Allcem Veneer APS cement in shade A3
• syringe (2,5q) of Allcem Veneer APS cement in shade Trans (Translucent)
• syringe (2,5q) of Allcem Veneer APS cement in shade Opaque
• syringe (2,5q) of Allcem Veneer APS cement in shade White
• syringe (2,5q) of Allcem Veneer APS cement in shades E-Bleach M
• syringes (2g) of Try-in

This document is a 510(k) premarket notification for a dental resin material, Allcem Veneer APS. The information provided describes the device's technical characteristics and performance compared to a predicate device (Variolink® Esthetic) to demonstrate substantial equivalence, rather than a clinical study evaluating an AI/ML powered device.

Therefore, many of the requested elements for an AI/ML device study (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or training set details) are not applicable or not provided in this document.

However, I can extract information related to the acceptance criteria for the material properties and the reported performance of the device based on established international standards.

Here's a breakdown of the requested information based on the provided text, focusing on the material's performance:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not explicitly state the total number of samples or specimens used for each test. For Film Thickness, 5 samples were listed for both Allcem Veneer APS and Variolink. Other tests refer to "results" or "specimens" without specific counts.
• Data Provenance: The studies were conducted by the manufacturer, Dentscare Ltda, based in Brazil (AV. EDGAR NELSON MEISTER, 474, JOINVILLE, SANTA CATARINA 89219-501 BRAZIL). The studies are non-clinical (laboratory-based) performance tests, not retrospective or prospective clinical data from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• For the "Stability of tone and color" test, three observers with normal vision, certified by a competent physician, were used for visual inspection.
• For other tests, the "ground truth" is defined by the ISO 4049 standard and measured by laboratory equipment, not human experts.

4. Adjudication Method for the Test Set:

• For the "Stability of tone and color" test, the judgment was based on consensus (implicitly, as "no color difference... attested" by all three observers).
• For other material property tests, adjudication methods are not applicable as they are objective laboratory measurements against a standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This document pertains to the
  substantial equivalence of a dental resin material based on mechanical and chemical properties, not a reader-dependent diagnostic AI/ML device.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a dental material, not an algorithm. The performance tests are for the material itself.

7. The type of ground truth used:

• The "ground truth" for the device's performance is established by objective measurements against the specifications outlined in international standards, primarily ISO 4049 (Dentistry Polymer-based restorative materials) and ISO 10993-1 (Biological evaluation of medical devices). For color stability, it's expert consensus (three observers).

8. The sample size for the training set:

• Not applicable. This is a physical dental material, not an AI/ML model, so 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 an AI/ML model, this question is irrelevant.

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The Llis and VITTRA APS composite is suitable for use in:

• Direct restorations in anterior and posterior teeth (I, II, III, IV, V e VI);
• Core build-ups;
• Teeth splinting;
• Indirect restorations such as inlays, onlays and veneers.
• Direct veneers with composites;
• Restoration of deciduous teeth
• Diastema closing or reduction;
• Modification of teeth's shape (e.g .: conoid teeth);
• Cementation of tooth fragments;
• Porcelain/composite repairs:

Llis is a radiopaque composite for anterior and posterior restorations. Its composition was based in modern concepts so that methacrylate monomers, silanes and fillers with adequate size distribution were combined to produce a product with differentiated physical, mechanical and optical properties. Llis presents a simplified shade system, offering enamel, dentin and incisal shades.

Vittra APS is a highly aesthetic light-curing composite resin recommended for restorations of all classes in anterior and posterior teeth. The composite is radiopaque; its loading particles are composed by spheres of a zirconia complex with average load particle size of 200nm, with total inorganic load of 72% to 82% in weight (52% to 60% in volume). Those characteristics contribute to enhance both mechanical and aesthetic properties, especially evidenced by how easy it is to obtain proper polishing and by the long-lasting surface shining. Vittra APS' formula is free of Bis-GMA and Bis-EMA, following the present trend of products free of Bisphenol A (BPA).

APS is the acronym for Advanced Polymerization System, and it consists of a combination of different photoinitiators that interact among each other amplifying the curing capacity of light emitted from light-curing units. Added to different materials, the system provides different advantages.

In the case of Vittra APS, APS adds as main benefit the reduction or elimination of visual shade and opacity alteration before/after light curing, which enhances the predictability of the result. Another factor is that, although there is very little concentration of camphorquinone - that has a yellowish aspect - APS has great power of polymerization allowing greater degree of conversion. The APS system is activated by any type of lightcuring unit available on the market, even those with less power or narrow range of wavelength.

The Dentscare LTDA Llis and VITTRA APS devices are tooth shade resin materials. The provided text outlines the acceptance criteria and study results for these devices.

Acceptance Criteria and Device Performance (Llis and Vittra APS)

The acceptance criteria are generally defined by compliance with ISO 4049 (Dentistry - Polymer-based restorative materials) and in some cases, by comparison to commercially available, internationally recognized quality composites.

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• All classes of direct restoration with composites (class I, II, III, IV and V);
• Adhesive luting (in addition to resin cement) of prosthetic pieces (post/cores, crowns, onlays/inlays, veneers etc.) made of fiberglass, ceromer, ceramic, resin and metal;
• Adhesive repairs in ceramic and composites.
  *Only for Ambar Universal APS: Use as metallic or ceramic primer.

Ambar APS is a light-curing 5th generation adhesive (two-step adhesive, total etch technique) for bonding restorative materials to dental tissue (enamel and/ or dentin). As the primer and the bonding agent are combined in a single bottle, acid etching is the only previous step needed before applying the adhesive to dentin and enamel.
Ambar Universal APS is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials. The primer and bonding agent are combined in a single flask. Prior use of acid etchant is optional on both tooth 's enamel and dentin, it can be used, therefore, in three ways: self-etch, selective-etch and total-etch.

This document, a 510(k) premarket notification from the FDA, describes DentsCare LTDA's dental bonding agents (Ambar APS and Ambar Universal APS) and their substantial equivalence to predicate devices. The listed information pertains to the non-clinical testing conducted to demonstrate the device's performance characteristics, not a human-in-the-loop AI study. Therefore, sections related to multi-reader multi-case (MRMC) comparative effectiveness, number of experts for ground truth, adjudication methods, or training set details are not applicable here.

The study proves the device meets acceptance criteria through a series of physical and chemical tests comparing the subject devices to internationally recognized commercial adhesives (predicates).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are explicitly stated as "if the adhesive under study has a mean $\ge$ than the competing adhesives analyzed," or similar comparative statements.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes (e.g., number of specimens tested) for each physical/chemical test. It presents mean values with standard deviations, which implies multiple measurements were taken for each test. The data provenance is not specified beyond being "non-clinical testing" and conducted for a Brazilian manufacturer (DentsCare LTDA). It is implicitly a prospective evaluation of newly manufactured devices under controlled laboratory conditions, not retrospective or prospective patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable. The "ground truth" for this type of non-clinical testing is established by physical and chemical measurements (e.g., MPa for strength, pH values) performed in a laboratory setting, not by human expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This section is not applicable, as the data collection involves objective physical/chemical measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This document describes non-clinical laboratory testing of dental bonding agents, not an AI-assisted diagnostic device evaluated with human readers.

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

Yes, in a sense, the performance described here is "standalone" to the device itself (the bonding agent) and its inherent physical/chemical properties, rather than its interaction with a human user or an AI algorithm. The performance metrics are intrinsic to the material.

7. The Type of Ground Truth Used

The ground truth used for these tests is objective, quantitative physical and chemical measurements obtained through laboratory testing, such as:

• Adhesive Strength: Measured in Megapascals (MPa).
• Conversion Rate: Percentage of monomer converted to polymer.
• Shear Bond Strength: Measured in Megapascals (MPa).
• pH: pH value.
• Viscosity: Measured in milliPascal-seconds (mPa.s).
• Water Sorption/Solubility: Measured in micrograms per cubic millimeter ($\mu g/mm^3$).
• Stability: Duration under specific temperature conditions.

8. The Sample Size for the Training Set

This section is not applicable. This is not an AI/machine learning study, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This section is not applicable, as there is no training set for this type of non-clinical device testing.

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Allcem and Allcem Core are indicated for the cementation of the tooth structure. It can be used for luting:

• · Porcelain fused-to-metal crowns and bridges;
• · Metal crowns, bridges, inlays and onlays (high noble, noble, and base metals);
• · Crowns and bridges with minimal tooth structure;
• · Maryland bridges (resin bonded bridges);
• · All ceramic/porcelain and pre-cured composite crowns, bridges, inlays and onlays;
• · Endodontic posts;
• • Only for Allcem Core: Core build-up.

ALLCEM: Allcem is a dual-curing radiopaque permanent resin cement system indicated for the cementation of indirect restorations to the tooth structure. The product is composed of a base paste and a catalyst paste, stored in a double-body syringe, which allows releasinq the correct proportion of each paste (1:1) and separating syringes of base paste and catalyst paste. Allcem is composed of methacrylate monomers, such as TEGDMA and BisEMA, inorganic load, photoinitiators, coinitiators, catalysts and pigments. Allcem presents adjusted viscosity allowing the formation of fine layers of cement with the appropriate covering of the parts.

ALLCEM CORE: Allcem Core is a dual-curing resin cement specially conceived for the adhesive cementation of intraradicular posts, crowns and core build-up . The product is commercialized in a double-body syringe, which facilitates obtaining the correct mixing proportions of the two pastes (1:1), and eases clinical procedures. By using an self-mixing tip with an applying nozzle (intracanal tip), it is possible to apply the cement inside the root canal and easily cement the post. The same tip can be used to add material to the crown region of the post to build up the core, Allcem Core is a composite of methacrylate monomers such as BisGMA, BisEMA and TEGDMA, inorqanic load, photoinitiators, coinitiators, catalysts and pigments. The cement associates the necessary flow for applications in canals with the ideal thixotropy for core build-ups.

The provided text outlines the acceptance criteria and the study that demonstrates the Dentscare LTDA 'Allcem' and 'Allcem Core' dental cements meet these criteria. The information is extracted directly from the "Non-clinical Testing" section of the document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Flexural Strength (dual cure): 5 specimens (CP 1-5)
• Sample Size for Flexural Strength (chemical curing): 5 specimens (CP 1-5)
• Sample Size for Film Thickness: 5 samples (Sample 1-5)
• Sample Size for Accelerated Stability Studies: Not explicitly stated, but the study period was 129 days.
• Sample Size for Long-Term Stability (Shelf) Evaluation: Not explicitly stated, but the study period was 24 months.
• Sample Size for other tests (Working time, Setting time, Water sorption and solubility, Radiopacity, Shear Bond Strength): Not explicitly stated, but tests were performed, and results are reported as meeting specifications.
• Data Provenance: The document does not specify the country of origin of the data for these non-clinical tests. The tests appear to be laboratory-based and conducted internally or by a contracted lab. The document does not indicate if the data is retrospective or prospective, but as it describes "tests were performed," it suggests a prospective testing approach for these specific evaluations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This section describes non-clinical, in-vitro testing based on established international standards (ISO and EN ISO). There is no mention of human experts establishing a "ground truth" for these measurements, as the ground truth is defined by the objective quantitative thresholds set by the standards themselves.

4. Adjudication Method for the Test Set

Not applicable for non-clinical, in-vitro physical and chemical property testing. The results are compared directly against the quantitative specifications of recognized international 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

Not applicable. This document pertains to a dental cement, not an AI-powered diagnostic or assistive device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This document pertains to a physical dental cement, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is represented by the quantitative specifications defined by recognized international standards, primarily EN ISO 4049, as well as ISO 10993 series for biocompatibility. For instance, for flexural strength, the ground truth is established by the standard's requirement of "≥ 50 MPa."

8. The Sample Size for the Training Set

Not applicable. This is a physical product, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical dental cement.

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Opus Bulk Fill APS

• Direct restorations in posterior teeth (permanent and deciduous) in increments of up to 5mm, including the occlusal surface;
• Class V restorations (cervical caries, root erosion, wedge-shaped defects)
• Reconstructive build-up;-
• Base and lining of direct restorations;
• Repair of small defects of the enamel;
• Repair of temporary acrylic and resin materials

Opus Bulk Fill Flow APS

• Base/lining underneath direct restorations.
• Small, non occlusal stress-bearing class I restorations according to minimally invasive filling therapy
• Pit and fissure sealant
• Tunnel-type preparation.
• Repair of enamel defects
• Bonding of tooth fragments.
• Repair in composite resin
• Non-carious cervical lesions.
• Planning of preparation walls.
• Core build-up

Opus Bulk Fill APS is a light-curing composite recommended for restorations performed in large increments. The technical characteristics of the product allow the professional to use increments of up to 5mm in the cavities, including the occlusal surface (it does not require an additional capping layer). The composite has approximately 79% of load filler (in mass). APS is the acronym for Advanced Polymerization System, and it consists of a combination of different photo initiators that interact among each other amplifying the curing capacity of light emitted from light-curing units.

Opus Bulk Fill Flow is a bulk-fill flowable light-curing composite (fluid) recommended to be used as base and lining of restorations on posterior teeth. That feature associated to its cure depth – due to the composite's translucency – allows Opus Bulk Fill Flow to be applied in increments of up to 4mm, reducing the time for restoring large cavities.

The Opus Bulk Fill APS and Opus Bulk Fill Flow APS devices are dental restorative materials. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not explicitly state the numerical sample size for each specific test, nor does it detail the provenance (e.g., country of origin, retrospective/prospective) of the materials tested. The tests were "pre-clinical tests" performed in a laboratory setting to evaluate physical and chemical properties.

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

For the Colour tone stability after radiation and water absorption test, three observers were used. Their qualifications are stated as: "normal eyesight (Tiago Vicente, Josley Habinzeureuter and Simone Brasil Carvalho), certified by a competent physician."

For other physical and chemical tests, "ground truth" is established by the specifications defined in the ISO standards (ISO 4049, ISO 7491), rather than expert consensus on a specific test set in the same manner as, for example, image interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

For the Colour tone stability test, the adjudication method was essentially a unanimous consensus of the three observers who "did not attest to any color difference in the samples analyzed." For other tests, the results are quantitative measurements compared against predefined ISO standard thresholds, not requiring expert adjudication in that context.

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:

This is not applicable. The devices (Opus Bulk Fill APS and Opus Bulk Fill Flow APS) are dental restorative materials, not AI-assisted diagnostic or assistive devices. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance was not performed.

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

This is not applicable. The devices are physical dental materials, not algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for evaluating the performance of these dental restorative materials is primarily based on international recognized standards (ISO 4049, ISO 10993-1, ISO 7491) which define objective physical and chemical properties and their acceptable ranges. For the color stability test, a form of expert consensus (three certified observers with normal vision) was used to visually confirm the absence of color change.

8. The sample size for the training set:

This is not applicable. These are physical materials, not machine learning algorithms. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established:
This is not applicable as there is no training set for a physical dental material.

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