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Vivasens® is a film-like varnish for the treatment of hypersensitive teeth. Indications include

• treatment of hypersensitive cervicals
• treatment of tooth sensitivities e.g. due to bleaching procedures
• treatment of sensitivities occurring after professional tooth cleaning, scaling and rootplaning procedures
• dentin-protection below restorative materials.
  It is Contraindicated if the patient has allergies to any ingredient; If the sensitivity arises from pulpitis or other dental disease; or for Pulp-capping.

Vivasens® is a film-like varnish for the treatment of hypersensitive teeth.

The provided document is a 510(k) K030922 clearance letter from the FDA for the device "Vivasens®," a film-like varnish for treating hypersensitive teeth. This type of regulatory submission establishes substantial equivalence to a predicate device and does not typically include detailed performance study data, acceptance criteria, or information on AI/ML components as requested in the prompt.

Therefore,Based on the provided text, the following information cannot be extracted:

• Acceptance Criteria and Reported Device Performance: This document does not describe specific acceptance criteria or report performance metrics from a study for the device. It is a regulatory clearance letter based on substantial equivalence to a predicate device, not a performance study report.
• Sample Size for Test Set and Data Provenance: No information about a test set, its sample size, or data provenance is provided.
• Number of Experts and Qualifications for Ground Truth: There is no mention of experts, their number, or qualifications for establishing ground truth.
• Adjudication Method: Adjudication methods are not discussed.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This study type is not mentioned, nor is any effect size for human readers with and without AI assistance.
• Standalone (Algorithm-Only) Performance: As this is not an AI/ML device, standalone algorithm performance is not applicable or discussed.
• Type of Ground Truth Used: No ground truth establishment method (e.g., expert consensus, pathology, outcomes data) is described.
• Sample Size for Training Set: There is no mention of a training set or its sample size.
• How Ground Truth for Training Set was Established: Training set ground truth establishment is not discussed.

Summary of Extracted Information:

The document primarily states the device name, its indications for use, and regulatory classification, confirming its clearance based on substantial equivalence. It does not contain the detailed study information sought regarding acceptance criteria and performance validation.

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