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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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Fusion Core DC Flo is indicated for use as core build up material on vital teeth, sealing root canal openings, cavity floor liner, post cementation, restorative material, and as a dentin replacement material.

Fusion Flo is indicated for direct filling of class V (cervical caries, root erosions, and wedge shaped defects), anterior restorations( Class III and IV), small posterior restorations, repair of composite/ceramic veneers, and blocking out of undercuts.

Fusion Flo SE is indicated for direct filling of class V (cervical caries, root erosion, wedge shaped defects), anterior restorations (Class III and IV), small posterior restorations,

Fusion I-Seal is indicated for Class I and Class II restorations, as a liner under composite restorations, and as a pit and fissure sealant.

Magma NT is indicated for direct restoration in anterior and posterior teeth classes I, III, IV and V, and porcelain/ composite repairs.

Fusion Core DC Flo is dual-curing, radiopaque, flowable restoration for core build-up composite supplied in an auto-mix delivery system.

Fusion Flo is a flowable composite of medium viscosity used for fillings in anterior teeth and small fillings in posterior teeth. Fusion Flo can be used separately or with Magma-NT composites.

Fusion Flo SE is a self-etch, self-adhesive flowable composite. The flowable composite is ready for use and doesn't require the preparatory steps of etching, priming and bonding. Fusion Flo SE can be used separately or with Magma-NT composites.

Fusion I-Seal is a single component, light cured flowable composite.

Magma-NT is a visible light cured, radio opaque highly filled hybrid composite restorative material for anterior and posterior restoration of all teeth.

The provided text describes the acceptance criteria and performance of several dental composite resins from Prevest Denpro Limited (Fusion Core DC Flo, Fusion Flo SE, Fusion I-Seal, and Magna NT) as part of a 510(k) premarket notification to the FDA. The study aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting the requirements of ISO 4049:2019 and ISO 13116:2014, with specific values mentioned for some parameters. The reported device performance indicates that "All test results met the criteria in standards."

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

The document does not explicitly state the sample sizes used for the test sets for each specific test (e.g., flexural strength, water sorption). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer, Prevest Denpro Limited, is based in India, so it's possible the testing was conducted there, but this is not confirmed.

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)

This information is not applicable to this type of device and study. The "ground truth" for dental composite resins is established through objective physical and chemical testing against international standards (ISO standards), rather than expert interpretation of images or clinical outcomes that require human assessment.

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

Not applicable. As noted above, the "truth" is determined by objective laboratory measurements against predefined 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 study concerns the physical and chemical properties of dental composite resins, not an AI-powered diagnostic device requiring evaluation of human reader performance.

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

Not applicable. This is not an algorithm or AI device.

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

The ground truth used for evaluating these dental composite resins is defined by international standard specifications for physical and chemical properties as outlined in ISO 4049:2019 (Dentistry - Polymer-based restorative materials) and ISO 13116:2014 (Dentistry - Dental impression materials - Radiopacity). For Fusion Flo SE, USP 971 was also referenced for pH testing. The "truth" is whether the measured properties of the device meet the quantitative limits set by these standards.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As this is not an AI device, there is no training set or ground truth established in that context.

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