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Premise Modified is a dental composite restorative material intended to be used in all classes of cavities.

The device is a light cured resin based composite dental restorative designed for direct placement. By utilizing three types of fillers, Premise Modified is designed to offer high polishability, high mechanical strength, and decreased polymerization shrinkage.

The provided text is a 510(k) summary for a dental composite restorative material called "Premise Modified." This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way an AI/ML device would. Instead, it focuses on demonstrating that the new device (Premise Modified) is substantially equivalent to an existing device (Premise) based on its intended use, design, and function.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study to prove device performance as it does not exist in the provided text for this type of medical device submission. The questions like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," "type of ground truth used," "sample size for the training set," and "how ground truth for the training set was established" are not applicable to this document because it is not describing an AI/ML device or a performance study with such metrics.

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