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• Treatment of hypersensitive teeth
• Use on exposed dentin and root sensitivity
• Under temporary restoratives and cements where post-operative sensitivity is of concern

Vanish Varnish is a topically applied, flavored cavity varnish containing sodium fluoride and calcium phosphate in a rosin based preparation. The varnish is an insoluble viscous liquid that forms a film on tooth surfaces.

The provided text is a 510(k) summary for the Vanish™ Varnish, 5% Sodium Fluoride White Varnish. It details the device's classification, predicate devices, description, and intended use. However, it does not contain any information about acceptance criteria, study methodologies (like sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance), or training set details.

The document mainly focuses on establishing substantial equivalence to previously marketed predicate devices based on properties, intended use, and composition. It mentions that "The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405." This indicates some testing was done for safety, but not for effectiveness or performance metrics that would typically involve a multi-reader, multi-case study or a standalone algorithm performance test.

Therefore, I cannot provide the requested information. The document primarily confirms the device's features and its equivalence to other legally marketed devices as per the 510(k) submission process, rather than detailing specific performance studies with acceptance criteria for an AI/ML powered device.

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