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• Direct anterior and posterior restorations (including occlusal surfaces)
• Base/liner under direct restorations
• Core build-ups
• Splinting
• Indirect restorations including inlays, onlays and veneers
• Restorations of deciduous teeth
• Extended fissure sealing in molars and premolars
• Repair of defects in porcelain restorations, enamel, and temporaries

3MTM ESPETM FiltekTM Bulk Fill Posterior Restorative material is a visible-light activated, restorative composite optimized to create posterior restorations simpler and faster. This bulk fill material provides excellent strength and low wear for durability. The shades are semi-translucent and low stress curing, enabling up to a 5 mm depth-ofcure. With excellent polish retention, Filtek™ Bulk Fill Posterior Restorative is also useful for anterior restorations that call for a semi-translucent shade. All shades are radiopaque. Filtek™ Bulk Fill Posterior Restorative is offered in A.I. A2. A3. B1. and C2 shades. Filtek™ Bulk Fill Posterior Restorative is applied to the tooth following use of a methacrylate-based dental adhesive, such as manufactured by 3M™ ESPETM. which permanently bonds the restoration to the tooth structure.

Filtek™ Bulk Fill Posterior Restorative is packaged in traditional syringes, for dispensing restorative on a pad outside the mouth, and single-dose capsules for dispensing restorative intraorally. The capsules are dispensed using the 3M ESPE Restorative Dispenser.

This document is a 510(k) summary for a dental restorative material, not a medical imaging or AI-based device, so many of the requested criteria (e.g., sample size for test set, number of experts, MRMC study, training set information) are not applicable.

However, I can extract the acceptance criteria and performance as presented for the physical properties of the dental material.

Acceptance Criteria and Reported Device Performance for Filtek™ Bulk Fill Posterior Restorative:

The submission indicates that "Test results for the following physical properties were included in this submission: Compressive Strength, Diametral Tensile Strength, Flexural Strength, Flexural Modulus, Surface Hardness, Radiopacity, Water Sorption, Water Solubility, Volumetric Shrinkage, Wear, Depth of Cure, Cusp Deflection and Polish Retention."

The overall "acceptance criterion" for this 510(k) submission is Substantial Equivalence to the predicate devices. The document explicitly states:

"Filtek™ Bulk Fill Posterior Restorative is substantially equivalent to the predicate devices, Filtek™ Supreme Ultra Universal Restorative, SonicFill, Sonic-Activated Bulk Fill Composite and Tetric EvoCeram Bulk Fill in terms of intended use, indications for use, physical properties, and technological characteristics. FiltekTM Bulk Fill Posterior Restorative is substantially equivalent to the predicate device, Filtek™ Supreme Ultra Universal Restorative in terms of formulation."

The study that proves the device meets the acceptance criteria (i.e., is substantially equivalent) involves a comparison of its technological characteristics and physical properties against predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Since specific numerical acceptance criteria (e.g., "Compressive Strength > X MPa") and corresponding reported performance are not detailed in this summary, the table will reflect the comparative nature of the substantial equivalence claim. The "acceptance criteria" here are essentially "similar to or better than predicate devices" for the listed properties.

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

• Sample Size: Not specified in the 510(k) summary. The document mentions "Test results for the following physical properties were included in this submission," implying laboratory testing, but does not provide specific sample quantities for each test.
• Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. As these are material property tests, they are typically conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable in the context of material property testing for substantial equivalence. The "ground truth" for material properties is established by adherence to recognized international standards (e.g., ISO).
• However, for biocompatibility, it states: "A Diplomate of the American Board of Toxicology assessed the safety of the product." This indicates at least one, highly qualified expert was involved in the safety assessment.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical diagnoses or interpretations, which is not the nature of this submission. The tests are based on objective physical measurements per ISO 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 device is a dental restorative material, not an AI-assisted diagnostic or imaging tool.

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:

• The "ground truth" for the performance claims is based on International Standardization Organization (ISO) standards for dental materials. Specifically, ISO 4049 and ISO 6874 are mentioned for certain properties, and the ISO 10993 series and ISO 7405 for biocompatibility.

8. The sample size for the training set:

• Not applicable. This is a physical material, not a machine learning model, so there is no "training set."

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

• Not applicable. (See #8)

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