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• Class III and V restorations
• Restoration of minimally invasive cavity preparations (including small, non stress-bearing occlusal restorations)
• Base/liner under direct restorations
• Repair of small defects in esthetic indirect restorations
• Pit and fissure sealant
• Undercut blockout
• Repair of resin and acrylic temporary materials

Filtek Supreme Ultra Flowable Restorative, is a low viscosity, visible-light activated, radiopaque, flowable nanocomposite. The restorative is packaged in capsules and syringes. It is available in a variety of toothcolored shades. The shades offered with Filtek Supreme Ultra flowable restorative were designed to coordinate with shades offered with Filtek™ Supreme Ultra Universal Restorative. Filtek Supreme Ultra flowable restorative contains bisGMA, TEGDMA and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a non-agglomerated/non-aggregated surface modified 20nm silica filler, a non-agglomerated/non-aggregated surface modified 75nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles). The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume).

The provided text describes a 510(k) submission for the "Filtek™ Supreme Ultra Flowable Restorative" dental device. However, this is a material rather than an AI-based or software device, and therefore the concepts of "acceptance criteria," "study" in the context of an AI device, "sample size for test set," "data provenance," "experts for ground truth," "adjudication method," "MRMC study," "standalone algorithm performance," and "training set" are not applicable in this document.

Instead, the submission focuses on demonstrating the substantial equivalence of the new dental restorative material to existing predicate devices through bench testing of physical properties and an assessment of biocompatibility.

Here's a breakdown of the relevant information from the document in the format requested, with NA (Not Applicable) for AI-specific criteria:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (dental restorative material), "acceptance criteria" are typically defined by comparing physical properties to predicate devices or established standards. The document states that the formulation was modified to improve certain physical properties. The "performance" is demonstrated by showing substantial equivalence in several properties.

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

This refers to bench testing samples, not patient data for an algorithm. The document does not specify the exact sample sizes for each physical property test.

• Sample Size: Not specified in the provided text, but implied to be sufficient for bench testing of physical properties to establish statistical relevance for comparison.
• Data Provenance: The data is generated from bench testing performed by the manufacturer, 3M ESPE Dental Products. It is laboratory-generated data, not patient data.

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 a dental material, not an AI device requiring expert-labeled ground truth from medical images or clinical data. The "truth" is established by direct physical measurements according to standardized testing methods.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are used to resolve discrepancies in expert labeling for AI/imaging studies. For a physical material, measurements are taken and compared.

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 not an AI/software device that assists human readers.

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

Not applicable. This describes a dental material, not an algorithm.

7. The Type of Ground Truth Used

For physical properties, the "ground truth" is the measured value of the property itself, obtained through standardized laboratory tests. For biocompatibility, the ground truth is established through risk assessment techniques and adherence to international guidelines like ISO 10993.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for a physical dental material like there would be for an AI algorithm.

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

Not applicable. As there's no training set, there's no ground truth to establish for it.

Summary of Device Meeting Acceptance Criteria:

The device, Filtek™ Supreme Ultra Flowable Restorative, meets its "acceptance criteria" by demonstrating substantial equivalence to the predicate devices (3M™ LVR System and Revolution Formula 2) in its intended use, indications for use, composition (with minor modifications), physical properties, and technological characteristics. The manufacturer performed bench testing to compare a range of physical properties (Compressive Strength, Diametral Tensile Strength, Flexural Strength, Flexural Modulus, Surface Hardness, Radiopacity, Water Sorption, Water Solubility, Polymerization Shrinkage, Polish Retention, and Fluorescence). The text explicitly states the formulation was modified to improve properties like fluorescence and polish retention, and the total assessment, including biocompatibility (evaluated against ISO 10993 standards), concluded the device is safe for its intended use. This evidence of comparable or improved performance for key physical characteristics, along with biocompatibility, forms the basis for the FDA's "substantially equivalent" determination.

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