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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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