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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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FUSION™ and FUSION™ Bioline Vascular Grafts are designed to repair or replace peripheral arteries.

FUSION™ Vascular Grafts are synthetic vascular grafts constructed of two layers. The inner layer is comprised of expanded polytetrafluoroethylene (ePTFE). The outer layer is comprised of knitted polyester textile. These two layers are bonded together. The FUSION™ Bioline Vascular Grafts have a heparin/albumin coating on the interior surface of the graft.

Here's an analysis of the acceptance criteria and the studies that support the FUSION™ and FUSION™ Bioline Vascular Grafts, based on the provided text:

Device: FUSION™ and FUSION™ Bioline Vascular Grafts

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around demonstrating substantial equivalence to the predicate device (EXXCEL™ Soft ePTFE Vascular Grafts), with specific performance targets derived from clinical and bench testing.

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

• Randomized Multicenter Trial (FUSION Bioline vs. EXXCEL):
  • Sample Size: 207 subjects randomized 1:1 (105 FUSION Bioline, 101 EXXCEL).
  • Data Provenance: Retrospective analysis of prospective data. Country of origin: 18 US centers and 7 European centers.
• European Postmarketing Trial (FUSION Graft):
  • Sample Size: 117 subjects enrolled. Preliminary 12-month results reported for 92 subjects.
  • Data Provenance: Retrospective analysis of prospective data. Country of origin: 10 European study centers.

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

This information is not provided in the document. The studies are clinical trials, and ground truth (e.g., patency, MALE) would typically be established by the treating physicians and clinical investigators overseeing the subjects. The document does not specify the number or qualifications of these individuals beyond them being involved in the respective trial centers.

4. Adjudication Method for the Test Set

This information is not explicitly provided in the document. For clinical endpoints like patency and MALE, adjudication often involves an independent clinical events committee (CEC), but the document does not detail if or how such adjudication was performed. The p-values suggest statistical analysis of collected data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The studies described are clinical trials comparing the device to a predicate (or historical data for the FUSION-alone trial) in human subjects, not a study assessing human reader performance.

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

This question is not applicable as the device is a physical vascular graft, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Clinical Trials (both FUSION Bioline vs. EXXCEL and FUSION Graft European Trial):
  • Patency: Assessed by vascular imaging and ABI (Ankle-Brachial Index). This represents clinical outcome data determined through objective measurements and clinical judgment.
  • Major Adverse Limb Events (MALE): Composite endpoint including major reintervention rates, major amputation rates, and periprocedural deaths. This is based on clinical outcome data/patient outcomes.
  • Suture-hole bleeding times: Measured clinically. This is clinical outcome data.
• Animal Studies:
  • Vascular compatibility, tissue response, patency: Assessed through in vivo observation, potentially histology, and imaging. This represents animal model outcomes/pathology.
• Bench Testing:
  • Physical properties: Measured against defined engineering specifications. This is based on laboratory testing results.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical vascular graft and does not involve AI or machine learning models that require a training set.

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

This question is not applicable for the same reason as above.

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