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FUSION Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access.

FUSION Vascular Grafts are synthetic vascular grafts constructed of two layers. The inner layer is comprised of extruded, expanded polytetrafluoroethylene (ePTFE). The outer layer is comprised of knit polyester textile. These two layers are fused together with a proprietary polycarbonate urethane adhesive.

This document is a 510(k) premarket notification for the FUSION Vascular Graft, specifically for an AV Access Indication. The acceptance criteria and study described pertain to the performance of this vascular graft.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria with specific numerical thresholds for "Burst After Repeated Puncture." However, it implies that the device's performance must be "comparable" to the currently marketed FUSION Vascular Graft.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "in-vitro tests" but does not specify the number of grafts or test articles used.
• Data Provenance: The study was "in-vitro testing" conducted as part of Maquet Cardiovascular's development process. The country of origin is not specified, but the applicant (Maquet Cardiovascular, LLC) is based in Wayne, NJ, USA. The study is prospective in the sense that it's conducted to support a new indication for the device.

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

This type of study (in-vitro performance testing of a physical device) does not typically involve human experts establishing "ground truth" in the way an AI diagnostic algorithm would. The "ground truth" is based on established engineering principles and measurement techniques for material and device performance. Therefore, this information is not applicable to this submission.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro performance study.

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 a 510(k) submission for a physical vascular graft, not an AI diagnostic device.

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

Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

For this in-vitro performance testing, the "ground truth" is based on the objective measurements obtained from standardized material and device performance tests, such as "Burst After Repeated Puncture." The performance is then compared against established performance of a predicate device (FUSION Vascular Graft) or internal benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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