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EsCom100 is a light curing, radiopaque composite filling material for both anterior and posterior applications and is indicated for all carious classes.

The EsCom100 is light-cured composite resin which makes it ideal for small cavities in anterior and posterior teeth. It has the characteristics of good handling, high compressive strength, and radiopaque. It has 18 shades: A1. A2. A3. A3.5. A4, B1, B3, C2, C3, D2, D3, AO2,AO3, PA1, PA2, PA3,PA3.5 (yellow).

The provided text describes a 510(k) submission for a dental composite material, EsCom100, and its substantial equivalence to a predicate device, ESTELITE SIGMA QUICK. However, the document does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of analytical or clinical performance of an AI/ML powered device.

The review section states that "The EsCom100 has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 4049." It also mentions that "The EsCom100 has the similar mechanical properties as the predicate device: compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience."

This indicates performance testing was done, but not in the format typically associated with AI/ML device studies where specific metrics (e.g., sensitivity, specificity, AUC) are set as acceptance criteria and then met by the device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving their fulfillment as the document pertains to a traditional medical device (dental composite) and not an AI/ML powered one. The request asks for details that are not applicable to the provided 510(k) summary.

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