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The MEADOX® EXXCEL™ ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Mid-Flex grafts are specifically indicated for vascular access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externerally Supported Grafts are used where kinking and compression resistance are desired.

The unwrapped version of the MEADOX® EXXCEL" ePTFE Vascular Graft is comprised of an expanded polytetraffuoroethylene (ePTFE) core tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.

The provided text describes the safety and effectiveness of the MEADOX® EXXCEL™ ePTFE Vascular Graft. It does not describe an AI device or a study involving human readers or algorithms. Therefore, much of the requested information regarding AI performance, human-in-the-loop studies, ground truth establishment for training data, and expert qualifications is not applicable.

However, I can extract the acceptance criteria and performance related to the device itself based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for this medical device are based on compliance with ISO-10993 standards for biocompatibility and AAMI standards (or equivalent) for physical performance. The reported device performance indicates that the device passed all these tests.

The study that proves the device meets these acceptance criteria is detailed in the "SUMMARY OF SAFETY & E" document provided. The document itself is the report of these tests.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify the exact sample sizes (number of grafts or test articles) used for each individual biocompatibility or physical performance test.
• Data Provenance: The tests were performed by "Meadox Medicals, Inc." and conducted according to international (ISO-10993) and national (AAMI) standards, implying data generated within a controlled laboratory setting. The country of origin is not explicitly stated for the data generation location, but the sponsor is "Meadox Medicals, Inc." and the submission is to the FDA (implying US jurisdiction). The data would be considered prospective for the purpose of demonstrating device compliance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not Applicable. This document describes engineering and biological testing of a physical medical device, not an AI device requiring expert ground truth in the diagnostic sense. The "ground truth" here is objective measurement against established physical and biological standards.

4. Adjudication Method for the Test Set:

• Not Applicable. As per point 3, this is not an AI study requiring adjudication of expert opinions. The adjudication is based on whether the measured performance of the device meets the predefined quantitative and qualitative criteria of the relevant standards (ISO and AAMI).

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 document does not describe an AI device or any human reader studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not Applicable. This document does not describe an AI algorithm.

7. The Type of Ground Truth Used:

• For Biocompatibility: The ground truth is adherence to the scientific and safety principles outlined in the ISO-10993 standard, demonstrated through in-vitro and in-vivo biological tests.
• For Physical Performance: The ground truth is the quantitative and qualitative specifications defined by the AAMI standards for vascular graft prostheses.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI device requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. This is not an AI device requiring a training set.

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