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Conventional application (Light intensity ≤2,000 mW/cm2):

• Restorations in the posterior region (Class I and II, including the replacement of individual cusps)
• Class V restorations (cervical caries, root erosion, wedge-shaped defects)
• Reconstructive build-ups
• Restoration of deciduous teeth
  Light-curing using the 3sCure mode of Bluephase® PowerCure (Light Intensity 3,050 mW/cm2):
• Restorations in the posterior region of permanent dentition (Class I and II, including the replacement of individual cusps) when light-cured from the occlusal aspect

Tetric® PowerFill is a light-curing radiopaque resin-based composite for the direct restorative treatment in posterior teeth. Tetric PowerFill cures with light in the wavelength range of 400-500 nm and can be applied in layers of up to 4 mm. The monomer matrix is composed of dimethacrylates (20-21 wt%). The fillers contain barium glass, ytterbium trifluoride, mixed oxide and copolymer (79-80 wt%). Additives, initiators, stabilizers and pigments are additional ingredients (

The provided text describes a 510(k) premarket notification for a dental restorative material called "Tetric® PowerFill." This document focuses on demonstrating that the new device (Tetric® PowerFill) is substantially equivalent to a legally marketed predicate device (Tetric EvoCeram Bulk Fill).

The acceptance criteria and study proving the device meets these criteria in the context of this document are related to bench testing of physical properties and biocompatibility, not a study involving human or AI readers or ground truth established by experts as would be common for diagnostic AI/ML devices.

Here's a breakdown of the information based on the provided text:

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

The document states that "Bench testing was performed to test the physical properties included in the Finished Device Specification for the subject device including: flexural strength, curing depth, sensitivity to light, wavelength for curing, water sorption and water solubility and radiopacity according to ISO 4049:2009." It also mentions "The subject device was tested in direct comparison to the predicate device and the results of the bench testing show the products to be substantially equivalent."

It also states that "The subject device was also evaluated for Biocompatibility according to ISO 10993-1:2009, ISO 7405:2008 and ISO 14971:2012. The following testing was conducted on the subject device: Cytotoxicity according to EN ISO 7405:2008 + A1:2013: ISO 10993-5:2009 and Genotoxicity according to EN ISO10993-3:2014 and the device was found to be non-cytotoxic and nongenotoxic."

While specific numerical acceptance criteria and performance data values are not explicitly provided in the text, the table below summarizes the types of criteria and the qualitative reported performance as stated.

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

This information is not provided in the given text as it pertains to a mechanical/chemical testing of a dental material, not a clinical study with a "test set" in the context of imaging or AI. The testing is described as "bench testing" and "evaluated based on a review of the literature."

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

This information is not applicable as the ground truth for physical and biocompatibility properties of a dental resin is established through standardized laboratory testing (e.g., ISO standards), not by human expert interpretation of images or other clinical data.

4. Adjudication method for the test set:

This information is not applicable for the reasons stated above.

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:

This information is not applicable as this document is for a dental restorative material, not an AI/ML diagnostic device that would involve human readers.

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

This information is not applicable as this document is for a dental restorative material, not an AI/ML algorithm.

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

The ground truth for the physical properties (flexural strength, curing depth, etc.) is established by standardized laboratory testing methods prescribed by ISO 4049:2009. For biocompatibility, the ground truth for cytotoxicity and genotoxicity is established by ISO 10993-5:2009 and EN ISO10993-3:2014 respectively, while other biocompatibility aspects (irritation, sensitization, systemic toxicity, implantation, pulp and dentin usage) were evaluated based on a review of scientific literature.

8. The sample size for the training set:

This information is not applicable as this document is for a dental restorative material undergoing physical and biocompatibility testing, not an AI/ML device requiring a training set.

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

This information is not applicable as this document is for a dental restorative material undergoing physical and biocompatibility testing, not an AI/ML device requiring a training set.

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