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The SimpliShade Bulk Fill is indicated for:

• Direct placement of anterior and posterior restorations.
• Core build-ups.
• Repair of defects in restorations.

The SimpliShade Bulk Fill Flow is indicated for:

• Base/liner under Class I and Class II direct restorations.
• Pit and fissure sealant.
• Restoration of small cavities.
• Class III and V restorations.
• Blocking out undercuts.
• Small core build-ups.
• Repair of resin and acrylic provisional restorations.

SimpliShade™ Bulk Fill Composite is offered in two types of viscosities: the high viscosity formula will be branded as SimpliShade™ Bulk Fill; the low viscosity formula will be branded as SimpliShade™ Bulk Fill Flow.

SimpliShade Bulk Fill is an intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative that is designed for the placement of direct restorations. SimpliShade Bulk Fill is designed to be used after placement of a dental adhesive, such as a product from the Kerr OptiBond™ family. SimpliShade Bulk Fill is available in Unidose™ compules and syringe delivery systems that are suitable for occlusal surfaces. The product offers allows a technique in which a cavity up to 5 mm in depth can be filled and cured in a single increment. SimpliShade Bulk Fill is offered in one universal shade to optically blend with a range of VITA™ shade guide equivalents. This composite can be polished with a wide variety of polishing discs, rubber cups, and brushes.

SimpliShade Bulk Fill Flow is an intra-oral, light-cured, esthetic, resin-based nanohybrid dental restorative that is designed to be used as a base or liner in Class I and II restorations and must be overlayed with a composite resin to replace the occlusal surfaces. It is also suitable to be used on nonocclusal-contact surfaces, such as pit and fissures, core build-ups and Class III and V restorations. SimpliShade Bulk Fill Flow is available in Unidose™ compules and syringe delivery systems. The product allows a technique in which a cavity up to 4 mm in depth can be filled and cured in a single increment. SimpliShade Bulk Fill Flow is offered in one universal shade to optically blend with a range of VITAM shade guide equivalents. Once light cured, the composite can be finished and polished using conventional finishing and polishing instruments.

The provided text is a 510(k) Summary for dental resin materials. It describes the acceptance criteria and study proving the device meets these criteria, but it focuses on non-clinical performance and does not include information about clinical studies with human participants or AI-assisted performance analysis. Therefore, I cannot generate information related to multi-reader multi-case studies, effect size of AI assistance, or standalone algorithm performance, as these are not present in the document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to international standards and internal benchmarks. The reported device performance indicates that the subject devices (SimpliShade™ Bulk Fill and SimpliShade™ Bulk Fill Flow) met these criteria.

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

The document does not specify the exact sample sizes (number of specimens tested) for each non-clinical test. It states that "Performance bench tests according to ISO 4049...have been conducted" and "Additional tests...have been performed." The data provenance is non-clinical laboratory testing, conducted by the manufacturer, Kerr Corporation, to demonstrate substantial equivalence to legally marketed predicate devices.

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 study involving material properties, not diagnostic interpretation by human experts.

4. Adjudication method for the test set

Not applicable. Ground truth for material properties is established through standardized testing procedures, not by human adjudication of observations.

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. This document describes the non-clinical performance of dental restorative materials. It does not involve AI, human readers, or clinical effectiveness studies in this context. The section "Clinical Performance Data" explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The nonclinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on the subject devices."

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

No. This document does not describe AI algorithm performance.

7. The type of ground truth used

The ground truth is established through physical and chemical property measurements according to established international standards (e.g., ISO 4049, ISO 10993 series) and internal company standards. This involves objective measurements rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is a non-clinical evaluation of material properties, not a machine learning model.

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

Not applicable. As there is no training set for a machine learning model, there is no ground truth established in that context.

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