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• As a structural reinforcement for fabricating and/or repairing Class III and Class V restorations
• Restoration of root surface caries
• Restorations of cervical erosions
• Small Class I restorations
• Primary teeth restoration
• Core build up
• Liner

Virto Fil LC is a dental cement that is composed of varoius materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges or to be applied to a tooth to protect the tooth pulp. Vitro Fil LC is a resin modified glass ionomer base cement used as a temporary tooth filling. Vitro Fil LC offers a strong bonding of the ionomer to the tooth. The glass ionomer offers high chemical adhesion, fluoride release and biocompatibility. Vitro Fil LC is for permanent cementation.

This document, K123824, is a 510(k) premarket notification for a dental cement called "Vitro Fil LC." It does not contain information about a study with acceptance criteria and reported device performance in the context of evaluation using a test set, ground truth, or expert review, as would be expected for an AI/ML powered device.

Rather, this document is a regulatory approval for a medical device (dental cement) based on its substantial equivalence to previously marketed predicate devices. The safety and effectiveness are established by comparing its intended use, materials, form factor, performance, and safety characteristics to those of the predicate devices.

Therefore, I cannot provide the requested information as it is not present in the provided text. The sections requested (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are typically associated with the evaluation of AI/ML software or diagnostic devices, not with traditional material-based medical devices like dental cement undergoing a 510(k) substantial equivalence review.

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• Class I, Class II, Class III and Class V restorations .
• Non-bearing Class I and Class II restorations in permanent teeth .
• Intermediate restoration for heavy stress situations in Class I and Class II . cavities
• Core build up .
• Liner .

Vitro Molar is a condensable, chemically activated glass ionomer cement, used in restorations of posterior teeth; it is radiopaque and offers good esthetic properties, easy manipulation, fast curing and it can be easily sculpted. It hardens via an acid/base reaction. Vitro Molar is also highly resistant to compression and bending, and has a hard, low-abrasive surface. It is ideal to be used in the atraumatic restorative treatment (ART) technique. Vitro Molar is for permanent cementation.

The provided text is a 510(k) summary for a dental cement called Vitro Molar. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving device performance against such criteria for an AI/ML powered device.

The document explicitly states: "Based on the information provided in this premarket notification, we can conclude that Vitro Molar is as safe and effective as the predicated devices." This indicates that the claim of safety and effectiveness for Vitro Molar is based on its similarity to existing, legally marketed predicate devices, not on a novel study demonstrating performance against specific acceptance criteria. This is a common approach for 510(k) submissions for conventional medical devices.

Therefore, I cannot provide the requested table or answer the specific questions related to acceptance criteria and performance studies. The information simply isn't present in the provided text.

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