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Nova Resin dual cure, self adhesive resin cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, bridges, posts and veneers. *

Additional indications include core-buildup material, pit and fissure sealant, and cementation of crowns restorations to implants.

• Adhesive application on the prep is required for veneer cementation using Nova Resin dual cure, self adhesive resin cement.

Resin Cement dual cure, self adhesive resin cement for the cementation of indirect restorations made of high strength all ceramic, composite, metal-ceramic and metal.

When Resin Cement dual cure, self adhesive resin cement is used, additional bonding agents are not required. The automix double syringe enables saving time direct application of the luting cement into restoration.

This document, an FDA 510(k) summary for the "NOVA RESIN dual cure, self adhesive resin cement," describes the device and its equivalence to a predicate device, but it does not describe an AI/ML device or its associated acceptance criteria and study data.

The document focuses on the physical and chemical properties of a dental cement. The "acceptance criteria" and "reported device performance" provided in the table are for these physical properties (e.g., film thickness, flexural strength), not metrics related to AI/ML performance like sensitivity, specificity, or AUC.

Therefore, I cannot extract the information requested regarding a study proving an AI/ML device meets acceptance criteria, as this document does not pertain to an AI/ML device.

Here's why the requested information cannot be found in the provided text:

• No mention of AI/ML device or algorithm: The entire document describes a dental cement and its physical properties. There is no mention of algorithms, machine learning, artificial intelligence, or any form of software that processes data for diagnostic or predictive purposes.
• Acceptance criteria are for physical properties: The table provided lists metrics such as Film Thickness, Working Time, Flexural Strength, etc. These are standard engineering and material science metrics for dental cements, not performance metrics for an AI system.
• No "test set," "training set," "ground truth," or "experts" in the AI context: These terms are specific to the validation of AI/ML models. The document refers to "non-clinical performance testing" which are bench tests, not clinical studies involving human experts or patient data for AI validation.
• No MRMC study: A Multi-Reader Multi-Case study is a type of clinical trial specifically designed to evaluate the impact of AI on human reader performance in medical imaging. The provided document does not mention any clinical studies of this nature.
• No "standalone performance": "Standalone" performance refers to the algorithm's performance without human intervention. This is irrelevant for a dental cement.

In summary, this document is a regulatory submission for a dental material, not an AI/ML medical device.

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