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FORMA Composite is designed for restorations in anterior and posterior teeth.
FORMA™ Composite is used for direct and indirect restorations in both the anterior and posterior regions.

FORMA™ Composite is a Bis-GMA-based restorative composite. FORMA™ composite is designed for restorations in anterior and posterior teeth and is suitable for occlusal surfaces. Its formula contains a zirconia/silica inorganic filler combination and barium glass. FORMA™ composite is shaded based on the VITA shade guide, and is radiopaque. FORMA™ composite has a radiopacity value greater than 2 mm of aluminum has a radiopacity equivalent to that of dentin. Thus, 1 mm of material having a radiopacity equivalent to 1 mm of aluminum has a radiopacity equivalent to that of dentin and 2 mm of aluminum is equivalent to enamel.
FORMA™ composite A3D is filled 78% w/w. FORMA™ composite is a nanohybrid composite with nanoparticles entombed within the composite's formulation.

The provided text describes a 510(k) premarket notification for a dental composite material called FORMA Composite. This document is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device, not a study performing statistical comparisons for AI/ML performance.

Therefore, the information required to answer most of your numbered points (especially those related to AI/ML device study parameters like sample size for testing/training set, expert ground truth establishment, MRMC studies, or standalone algorithm performance) is not present in the provided document.

The document focuses on the physical, chemical, and biological properties of the dental composite, and its comparison to a predicate device, as required for a Class II dental device submission. It does not describe an AI/ML medical device.

However, I can extract the following information that is relevant to "acceptance criteria" and "proof of meeting criteria" as it relates to this dental composite device:

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

The document outlines physical properties that serve as "acceptance criteria" by comparing the subject device (FORMA Composite) to the predicate device and asserting compliance with ISO standards.

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

• Test Set Sample Size: Not specified in terms of number of experimental units (e.g., number of samples for each physical test). The document states "Full testing to ISO 4049:2019, surface hardness evaluation, drop test ship testing, and an assessment on the curing wavelength, curing intensity and curing time were completed for the product verification testing." It also mentions "Simulated use and validation testing was conducted by dental professionals." The specific number of tests or samples is not provided.
• Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing performed by Ultradent Products, Inc. (manufacturer). No country of origin for data is mentioned. The testing is implied to be prospective, as it was conducted for this specific submission.

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

• Not applicable in the context of defining "ground truth" for a physical dental composite.
• "Dental professionals" were used for "simulated use and validation testing," but their number and specific qualifications (other than being dental professionals) are not detailed.

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

• Not applicable. This is for consensus-based labeling or image interpretation, not physical product 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:

• No. This is a dental composite material, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant here.

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

• No. This is a dental composite material, not an AI/ML device.

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

• For physical/chemical properties: Standardized Laboratory Testing/Measurements according to ISO standards (e.g., ISO 4049:2019 for dentistry - polymer-based restorative materials, and ISO 7405:2018 and ISO 10993-1:2018 for biological evaluation). The "ground truth" is established by the methods outlined in these international standards.
• For usability: Simulated use by dental professionals validated against predefined user needs and indications for use.

8. The sample size for the training set:

• Not applicable. This document describes a traditional medical device (dental composite), not an AI/ML device that requires a "training set."

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

• Not applicable. See point 8.

In summary, the provided document details the regulatory submission for a physical dental material and does not contain information related to AI/ML device studies or their associated evaluation metrics and methodologies.

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