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The ESTELITE UNIVERSAL FLOW device is indicated for use as a tooth shade resin material in dental procedures, such as:

• Direct anterior and posterior restorations
• Cavity base or liner
• Blocking out cavity undercuts before fabricating indirect restorations
• Repair of porcelain/composite

The ESTELITE UNIVERSAL FLOW tooth shade resin device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations. The device incorporates Radical-Amplified Photopolymerization initiator technology (RAP technology), which facilitates a shortened light curing time and ample working time.
ESTELITE UNIVERSAL FLOW comes in three viscosities: High, Medium, and Super Low. The device is available in either a syringe or pre-loaded tip. Each type contains spherical silica-zirconia filler and composite filler. The spherical filler has mean particle size of 200 and a particle size range of 100 to 300 nm.
The device does not come sterilized and is not intended to be sterilized prior to use.

Here's a breakdown of the acceptance criteria and study information for the ESTELITE UNIVERSAL FLOW device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for the non-clinical tests (e.g., how many specimens were tested for flexural strength). It only states that the testing was conducted in accordance with ISO 4049:2009. ISO standards typically specify minimum sample sizes for such tests.

The data provenance is non-clinical testing conducted by the manufacturer, Tokuyama Dental Corporation. The country of origin of the data is not specifically mentioned, but the manufacturer is based in Japan. This testing is prospective for the ESTELITE UNIVERSAL FLOW device, as it was performed to demonstrate conformity.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a dental material, and the "ground truth" for its performance characteristics is established by adherence to physical and chemical property standards (ISO 4049:2009), not by expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. The "test set" involves physical and chemical property measurements against a standard, not interpretations requiring adjudication.

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-powered diagnostic or assistive technology for human readers.

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

Not applicable. This is a material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is the requirements specified in ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials." The device's physical and chemical properties were measured and compared against these established international standards.

For biocompatibility, the ground truth relies on the established safety record of identical ingredients used in previously authorized devices (ESTELITE BULK FILL Flow, ESTELITE SIGMA QUICK, and ESTELITE FLOW QUICK) over many years without reportable adverse incidents. This is justification for not requiring further biocompatibility testing under Section 6 of ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as no training set was used.

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For use as a tooth shade resin material in dental procedures, such as:

• Direct anterior and posterior restorations
• Direct bonded composite veneer
• Diastema closure
• Repair of porcelain/composite

The OMNICHROMA device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA device is available in only one shade.

The device does not come sterilized and is not intended to be sterilized prior to use.

The provided text describes the 510(k) premarket notification for the OMNICHROMA tooth shade resin material. It does not contain information about a comparative effectiveness study involving AI or human readers, nor does it detail acceptance criteria and performance data in the context of an AI device. The document is for a dental restorative material, not an AI-powered diagnostic or assistive device.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to an AI device.
• Sample sizes, data provenance, and expert details for a test set for an AI device.
• Adjudication methods for an AI device's test set.
• MRMC study details or effect sizes for human readers with/without AI assistance.
• Standalone performance for an AI algorithm.
• Ground truth types in the context of AI.
• Training set sample size and ground truth establishment for an AI device.

The provided document focuses on the physical and chemical properties of a dental resin and its substantial equivalence to a predicate device based on non-clinical testing according to ISO 4049. There is no mention of AI, diagnostic performance, or human reader studies.

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