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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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