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Nano-Bond II Adhesive System is used for the adhesion of dentin to various polymeric filling materials (composites) and used with other conditioners or combination of conditioners for bonding composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to dentin and enamel.

Nano-Bond II Adhesive System is a light-cured, reinforced dentin bonding agent. It is provided in a kit containing two components, Nano-Bond Self-Etch Primer and Nano-Bond II Adhesive and an optional component, Nano-Bond II Dual Cure Activator. The components also are available individually as refills.

This document describes a 510(k) premarket notification for the "Nano-Bond II Adhesive System". This submission is for a dental adhesive, not an AI/ML powered device. As such, the information you've requested regarding AI/ML device performance criteria, studies, and data provenance is not applicable to this 510(k) submission.

The document focuses on demonstrating substantial equivalence to a predicate device ("Nano Bond (Bond-3 Adhesive) (K020499)") based on intended use and design principles. It does not contain sections on acceptance criteria in the context of diagnostic performance metrics, details of clinical study design with human readers, ground truth establishment, or sample sizes for training/test sets as would be relevant for an AI/ML medical device.

Therefore, I cannot extract the requested information because it is not present in the provided text, which pertains to a traditional dental adhesive system.

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