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everX Posterior is indicated for use as a fiber reinforced composite for the restoration of prepared carious teeth, including large posterior cavities with loss of dentin.

everX Posterior is a light-cured, fiber-reinforced, universal type composite resin packaged in a unitip and available in one universal shade.

Here's an analysis of the provided text regarding the acceptance criteria and study for the everX Posterior dental device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it states that bench testing was performed in accordance with ISO 4049:2009 Dentistry - Polymer based restorative materials, and that the "testing results indicate that the device conforms to the required specifications."

Based on the information provided, the key performance criteria for everX Posterior are:

For biocompatibility, the criteria are defined by ISO 10993-1, with specific tests:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the bench tests.
The data provenance is not explicitly stated in terms of country of origin, but it is from non-clinical laboratory bench testing. The study is retrospective in the sense that the results are being presented as completed tests rather than a prospective study setup.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies described are non-clinical bench tests (physical and chemical properties, biocompatibility) of a material, not diagnostic or clinical interpretation studies requiring human expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Bench tests follow standardized procedures, and the results are typically measured objectively by instruments or established laboratory methods, not through expert 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

An MRMC comparative effectiveness study was not done. This device is a dental restorative material, not an AI-powered diagnostic tool. Therefore, human reader improvement with or without AI assistance is not relevant to its evaluation.

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

This information is not applicable. The device is a physical dental material, not an algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the physical and chemical properties (e.g., flexural strength, depth of cure, water sorption, solubility, color stability), the "ground truth" is established by the defined specifications and test methods outlined in ISO 4049:2009. The device's performance is measured against these objective standards.
For biocompatibility, the "ground truth" is established by the scientific consensus and methodologies defined in ISO 10993-1, ISO 10993-5, and ISO 10993-10 for evaluating biological responses to medical devices.

8. The Sample Size for the Training Set

This information is not applicable. The testing described is for a physical material's properties and biocompatibility, not for training a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

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