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• Base under Class I and Class II direct restorations
• Liner under direct restorative materials
• Restoration of small cavities
• Class III and V restorations
• Core build-ups

Any-Com Bulk is a light cured. radiopaque, flowable restorative material for both posterior and anterior restorations. It is designed to be used as a base-liner for Class I and II restorations. The product allows a technique in which a cavity up to 4mm in depth can be filled and cured in a single increment. The product offers 5 shades options available. Users can select shades such as A 1, A2, A3, TL and Blue, based on the desired brightness, yellowness, and darkness that match the patient's natural teeth. After the appropriate tooth pretreatment process, fill the appropriate amount of product to applying area. Once light cured, the composite can be finished and polished using conventional finishing and polishing instruments.

The provided text is a 510(k) summary for a dental restorative material called "Any-Com Bulk." It is a submission to the FDA seeking substantial equivalence to a legally marketed predicate device. The document focuses on demonstrating that the new device is as safe and effective as the predicate.

However, the question asks for acceptance criteria and study details related to a device that uses AI (given the questions about multi-reader multi-case studies, ground truth establishment for training, etc.). The provided text describes a tooth shade resin material (a bulk fill flowable restorative), which is a physical material and not an AI-powered device.

Therefore, I cannot extract the requested information because the document does not pertain to an AI device. There are no tables of acceptance criteria for AI performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details for an AI model.

The document discusses non-clinical tests for a material, such as:

• Performance Tests: Appearance, Weight, Packaging, Sensitivity to Ambient Light, Curing Depth, Flexural Strength, Water Sorption/Solubility, Color and Color stability, Radiopacity in accordance with ISO 4049.
• Biocompatibility Tests: Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute/Subchronic Toxicity, Genotoxicity, Implantation, Chronic Toxicity, Carcinogenicity (all conforming to ISO 10993 series).

These are typical tests for a dental material, not an AI software device.

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