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The primary indication of the Leaderflex catheter is pressure monitoring in peripheral arteries. The device may also be used for venous access in pediatric patients.

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This document is a FDA 510(k) clearance letter for the Vygon Leader-Flex intravascular catheter. It declares the device substantially equivalent to a legally marketed predicate device. This type of document does not contain the information requested in your prompt regarding acceptance criteria and performance study details.

The letter is a regulatory document confirming market clearance, not a clinical study report. Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on the regulatory equivalence of the device, stating its intended use is for "pressure monitoring in peripheral arteries" and "venous access in pediatric patients."

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