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The catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allow(s) for central venous pressure monitoring, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5mL/section of contrast media. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.

The Vygon PICCs are sterile, single-use, polyurethane PICCs with the same intended use, indications for use, similar design, similar sizes, similar or the same materials, and similar properties as the predicate device.

The provided document details the Vygon PICCs device, its intended use, and substantial equivalence to a predicate device, focusing on various performance and safety tests. However, the document does not describe an algorithm or AI-driven device, nor does it present acceptance criteria and performance data in the context of such a device.

Therefore, many of the requested items (e.g., sample size for AI test sets, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this submission, as it pertains to a physical medical device (Vygon PICCs) and not a software or AI-based diagnostic/screening tool.

The document primarily focuses on bench testing, sterilization testing, and biocompatibility testing to demonstrate that the Vygon PICCs are substantially equivalent to the predicate device (5 Fr DL PowerPICC® Catheter).

Here's an attempt to extract the relevant information based on the provided document, addressing the prompt's categories where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like a PICC, the "acceptance criteria" are typically the satisfactory completion of standardized tests and meeting the requirements outlined in those standards. The "reported device performance" is whether the device "Passed" each test.

2. Sample sized used for the test set and the data provenance:
For a physical device, "sample size" refers to the number of units tested. The document does not explicitly state the sample sizes for each bench, sterilization, or biocompatibility test. The data provenance is internal testing performed by Vygon USA (the submitter). The context implies these are prospective tests conducted on the final device. No country of origin for the data is specified beyond the submitter's location (Lansdale, PA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is subjected to standardized physical and chemical tests, not an assessment requiring expert "ground truth" derived from clinical cases or images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or image interpretations. The tests performed are objective, pass/fail criteria based on adherence to international standards and internal requirements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-driven device or study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device is compliance with established engineering and biological standards and specifications.

8. The sample size for the training set:
Not applicable. This is not an AI/algorithm-based device, so there is no training set.

9. How the ground truth for the training set was established:
Not applicable. There is no training set.

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