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• Base under Class I and II direct restorations .
• Liner under direct restorative materials .
• . Pit and fissure sealant
• Restoration of minimally invasive cavity preparations (including small, ◆ non stress-bearing occlusal restorations)
• Class III and V restorations .
• . Undercut blockout
• Repair of small enamel defects .
• Repair of small defects in esthetic indirect restorations .
• Repair of resin and acrylic temporary materials .
• As a core build-up where at least half the coronal tooth structure is . remaining to provide structural support for the crown

Filtek™ Bulk Fill Flowable Restorative, is a low viscosity, visible-light activated, radiopaque, flowable. This low stress flowable material is semitranslucent enabling a 4mm depth of cure. The restorative is packaged in capsules and syringes. The shades offered with Filtek™ Bulk Fill flowable are U (Universal), A1, A2, and A3. Filtek™ Bulk Fill flowable contains bisGMA, UDMA, bisEMA(6) and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particle sizes from 0.1 to 5.0 microns and zirconia/silica with a particle size range of 0.01 to 3.5 µm. The inorganic filler loading is approximately 64.5% by weight (42.5% by volume). A dental adhesive is used to permanently bond the restoration to the tooth structure.

Filtek™ Bulk Fill Flowable Restorative is a modification of predicate device Filtek™ Supreme Ultra Flowable Restorative. The formulation was modified to increase depth of cure, while decreasing polymerization shrinkage stress.

The provided text describes a 510(k) submission for a dental restorative material, not an AI/ML powered device. As such, the requested information regarding acceptance criteria, study details (sample size, data provenance, ground truth, MRMC study, standalone performance), and training set details for a device meeting acceptance criteria and proven by a study is not present.

The document focuses on demonstrating substantial equivalence of the Filtek™ Bulk Fill Flowable Restorative to predicate devices. This is achieved through bench testing of physical properties and an assessment of biocompatibility and risk management.

Here's an analysis of the provided text in relation to your request, highlighting what is not available:

1. A table of acceptance criteria and the reported device performance:

• Not Available directly as a table for "acceptance criteria" and "reported device performance" in the AI/ML context.
• The document states: "This 510(k) submission includes data from bench testing to evaluate the performance of Filtek™ Bulk Fill Flowable Restorative compared to predicate devices Filtek™ Supreme Ultra Flowable Restorative, Adaptable Composite Resin Restorative Material and Revolution™ Formula 2. Standards utilized include ISO 4049.2009 and ISO 6874:2005. Properties evaluated include Compressive Strength, Diametral Tensile Strength, Flexural Strength, Flexural Modulus, Surface Hardness, Radiopacity, Water Sorption, Water Solubility, Cusp Deflection, Volumetric Shrinkage, Wear and Depth of Cure."
• The "acceptance criteria" here are implied to be meeting or being comparable to the performance of the predicate devices and relevant ISO standards for these physical properties. The reported device performance for each of these specific properties is not explicitly listed in the summary but would have been part of the full 510(k) submission.

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

• Not available. The document mentions "bench testing" but does not specify sample sizes for these tests, nor the "provenance" in terms of subject or data origin, as this is a material science evaluation, not a clinical study involving human data.

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):

• Not applicable/available. This section refers to AI/ML ground truth establishment. For this dental material, "ground truth" is established by standard material science testing and adherence to ISO standards.
• One "Diplomate of the American Board of Toxicology" assessed biocompatibility, which is a different type of expert review, not related to an AI/ML ground truth for a test set.

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

• Not applicable/available. Adjudication methods are relevant for expert consensus in AI/ML performance evaluation and are not described here for material property testing.

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/available. This is a question specifically for AI/ML devices. No human reader studies are mentioned, as the device is a dental restorative material, not an AI aid for diagnosis or treatment planning.

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

• Not applicable/available. This question is also specific to AI/ML algorithms.

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

• Not applicable/available in the AI/ML sense. The "ground truth" for this device's performance is based on established scientific measurement methods for material properties (e.g., compressive strength, depth of cure) as defined by ISO standards 4049.2009 and 6874:2005. Biocompatibility "ground truth" is derived from toxicology assessments and ISO 10993 and 7405 standards.

8. The sample size for the training set:

• Not applicable/available. There is no "training set" as this is not an AI/ML device.

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

• Not applicable/available. There is no "training set."

In summary, the provided document describes the 510(k) submission for a non-AI dental material. Therefore, most of the requested information pertaining to AI/ML device evaluation criteria and study design is not present or applicable. The document focuses on demonstrating substantial equivalence based on material properties, biocompatibility, and risk management through bench testing and adherence to established standards, rather than clinical efficacy through human evaluations or AI model performance.

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