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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 device is indicated for use for direct anterior and posterior restorations, cavity base or liner, and repair of porcelain/ composite.

The OMNICHROMA FLOW tooth shade resin material is a paste that comes in a plastic syringe (1.8mL). The device is a low viscosity, light-cured, radiopaque composite resin for use in anterior and posterior restorations for all carious classes. OMNICHROMA FLOW is a single shade material. Direct placement of OMNICHROMA FLOW into a prepared cavity allows for easy handling.

OMNICHROMA FLOW is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm. Be sure to light-cure OMNICHROMA FLOW extra-orally and check the time needed for complete hardening of OMNICHROMA FLOW with your lightcuring unit before performing the bonding procedure.

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 OMNICHROMA FLOW device contains methacrylic monomers and a UV absorber. The device should not be used on patients who are allergic to or hypersensitive to methacrylic and related monomers, UV absorber, or any of the other ingredients.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the OMNICHROMA FLOW tooth shade resin material.

Here's the breakdown of the information requested:

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

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 specific sample sizes for each physical property test. It mentions that "Non-clinical testing of the physical properties of the OMNICHROMA FLOW device was conducted in accordance with ISO 4049:2009, 'Dentistry -- Polymer-based Restorative Materials.'" The ISO standard would define the required sample sizes for each test.

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied that the testing was conducted by or for Tokuyama Dental Corporation, a Japanese company.

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. The device is a "tooth shade resin material," and its performance is evaluated against engineering standards (ISO 4049) and biocompatibility, not by expert interpretation of images or clinical outcomes that would require ground truth established by medical experts like radiologists.

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

This information is not applicable as the study involves physical property testing against an engineering standard, not clinical adjudication of diagnoses or interpretations.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a dental restorative material, not an AI-assisted diagnostic tool.

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

This question is not applicable. The device is a physical material, not an algorithm. The performance testing was of the material itself.

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

The ground truth for the physical property testing is based on the requirements and methodologies outlined in ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials," which are standardized engineering and material science criteria. For biocompatibility, the ground truth is established by standard biological evaluation methods (cytotoxicity, sensitization, oral mucosa irritation, subacute systemic toxicity, acute systemic toxicity, and genotoxicity testing).

8. The sample size for the training set

This information is not applicable. The device is a physical material, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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

This information is not applicable for the reason stated in point 8.

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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.

Ask a specific question about this device