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• Restorations in the posterior region (Classes I and II, including replacement of individual cusps)
• Restorations of class V (cervical caries, root erosions, wedge-shaped defects)
• Core build-up
• Restorations in deciduous teeth

Ecosite Bulk Fill is a light-curing, radiopaque restorative material developed especially for use in the posterior region.

This document is a 510(k) premarket notification for a dental material, Ecosite Bulk Fill. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data. Therefore, many of the requested categories related to studies involving human readers, clinical trials, or extensive ground truth establishment are "Not Applicable" or "Not Provided" in this submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the comparative performance to the predicate device, Nanocomposite (K080480), and the adherence to relevant FDA guidance and ISO standards for dental materials. The acceptance is that Ecosite Bulk Fill's properties are "substantially equivalent" to those of the predicate device.

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

The document does not explicitly state the "sample size" for each specific physical and mechanical property test. The study is a non-clinical performance study focusing on in-vitro testing. The data provenance is internal testing conducted by the manufacturer, comparing their proposed device to the reported properties of the predicate device. It is not retrospective or prospective clinical data from patients or humans.

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

Not applicable. This is a non-clinical, in-vitro performance study. Ground truth in the sense of expert consensus on clinical findings is not relevant here. The "ground truth" for the material properties is established by standardized testing methods.

4. Adjudication method for the test set

Not applicable. This is a non-clinical, in-vitro performance study. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies or image interpretation.

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 tool for human readers.

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

Not applicable. This device is a dental restorative material, not an algorithm. The "standalone" performance here refers to the physical and mechanical properties of the material itself.

7. The type of ground truth used

The ground truth used for these non-clinical performance tests are measurements and observations from standardized physical and mechanical tests, conducted according to recognized industry standards (e.g., ISO and FDA Guidance for Industry and FDA Staff: "Dental Composite Resin Devices – Premarket Notification [510(k)] Submissions").

8. The sample size for the training set

Not applicable. This is a physical material with properties measured directly, not a machine learning model requiring a training set.

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

Not applicable. As above, there is no training set for this type of device submission.

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