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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 OMNICHROMA FLOW BULK is a low viscosity, light-cured, radiopaque composite tooth shade resin material for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA FLOW BULK device is a single shade material. Direct placement of the OMNICHROMA FLOW BULK device into a prepared cavity allows for easily handling. The OMNICHROMA FLOW BULK device is a flowable material which can be placed in 3.5mm increments.
The OMNICHROMA FLOW BULK device contains 1,6-bis(methacrylethyloxycarbonylamino)trimethyl hexane (UDMA), triethylene glycol dimethacrylate (TEGDMA), mequinol, dibutyl hydroxyl toluene, and UV absorber.
OMNICHROMA FLOW BULK is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm.
The device is intended for use by licensed healthcare professionals only. The device does not come sterilized and is not intended to be sterilized prior to use.

The provided document outlines the substantial equivalence of OMNICHROMA FLOW BULK, a tooth shade resin material, to existing predicate devices. It does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, I cannot provide details on acceptance criteria or study elements related to AI performance, multi-reader multi-case studies, or ground truth establishment in the context of an AI device.

The document focuses on the physical and chemical properties of the dental resin and its compliance with ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials."

Here's an analysis of the provided text in relation to your request, highlighting where information is absent for an AI device:

Acceptance Criteria and Device Performance (for a physical dental material):

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

The acceptance criteria for the OMNICHROMA FLOW BULK device are its conformity to the requirements of ISO 4049:2009. The reported device performance for all tested physical properties (Sensitivity to ambient light, Depth of cure, Flexural strength, Water sorption, Solubility, Color stability, Radio-opacity) is that it "Conformed to the requirement of ISO 4049".

Since this document describes a dental material and not an AI model, the following points of your request are not applicable or information is not present in the provided text.

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

• The document states "Non-clinical testing of the physical properties of the OMNICHROMA FLOW BULK device was conducted in accordance with ISO 4049:2009". It does not specify the sample size (e.g., number of material samples tested) for each physical property.
• Data provenance (country of origin, retrospective/prospective) is not applicable or mentioned as this is materials testing, not patient 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. Ground truth in this context refers to the defined physical and chemical properties as measured in a lab according to ISO standards, not expert consensus on medical images.

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

• Not applicable. No expert adjudication is described 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. This is not an AI device.

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

• Not applicable. This is not an AI algorithm.

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

• For material properties, the "ground truth" is established by highly controlled laboratory measurements and adherence to the specifications outlined in the international standard ISO 4049:2009.

8. The sample size for the training set:

• Not applicable/not specified. The device is a physical material, not an AI model requiring a training set.

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

• Not applicable. There is no training set mentioned or implied for this submission.

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

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

ESTELITE BULK FILL Flow is a low viscosity, light cured radiopaque composite dental tooth shade resin material. This low stress flowable material can be placed in 4 mm increments. The device incorporates Radical-Amplified Photopolymerization (RAP) initiator technology, which facilitates a shortened light curing time and ample working time. The device comes in five shades, namely U (Universal), A1, A2, A3, and B1.

This document describes the premarket notification (510(k)) for the Tokuyama Dental Corporation's "ESTELITE BULK FILL Flow tooth shade resin material." The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document provides a table comparing the new device (ESTELITE BULK FILL Flow) to its primary predicate (ESTELITE FLOW QUICK) and references ISO 4049:2009 for many properties.

Note: The document explicitly states "Conformed to the requirement of ISO 4049" for several physical properties, implying these are the acceptance criteria and the device met them. For other properties, the predicate's performance serves as the benchmark for substantial equivalence.

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

The document does not explicitly state the sample sizes used for the non-clinical physical property tests. It only states that the testing was "conducted in accordance with ISO 4049:2009," which would imply adherence to its specified sample sizes if applicable.

The provenance of the data is implied to be from Tokuyama Dental Corporation, which is based in Japan, as per the submitter information. The testing is non-clinical, so the retrospective/prospective distinction for human data is not applicable.

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)

This information is not applicable as the studies conducted were non-clinical, measuring physical properties of the material in a laboratory setting, not evaluating diagnostic performance with human judgment.

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

This information is not applicable as there were no human expert judgments or adjudications involved in establishing the ground truth for the physical property tests.

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

No. An MRMC comparative effectiveness study was not done. The device is a dental material, not an AI-assisted diagnostic tool. The document states: "There were no clinical tests performed for the ESTELITE BULK FILL Flow device."

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

Yes, in a sense, a standalone assessment of the material's properties was performed by conducting non-clinical physical property tests. However, this is not a "standalone algorithm" in the context of AI. It refers to the intrinsic performance of the material itself.

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

The ground truth for the performance data of the device was established through laboratory measurements of physical properties according to published standards (ISO 4049:2009). For biocompatibility, the ground truth was based on prior FDA authorization of the device's ingredients in other similar devices and the historical absence of adverse events.

8. The sample size for the training set

This information is not applicable. The device is a dental material, not an AI/ML algorithm that requires a training set. The performance data presented are from testing the physical properties of the final product.

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

This information is not applicable as there was no training set for an AI/ML algorithm.

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