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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.

AI/ML Overview

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.

Acceptance Criteria (Implied)	Reported Device Performance
Functionality comparable to currently marketed FUSION Vascular Graft	"The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed FUSION Vascular Graft."
Performance characteristics comparable to currently marketed FUSION Vascular Graft	"The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed FUSION Vascular Graft."
"Burst After Repeated Puncture" performance satisfactory	Performance testing was conducted for "Burst After Repeated Puncture" and found to be comparable to the predicate device.

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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K Number

K131778

Device Name

FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT

Manufacturer

MAQUET CARDIOVASCULAR LLC

Date Cleared

2013-11-14

(150 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K962433,K052964,K113101

Intended Use

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

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Implicit from Predicate Equivalence and Study Goals)	Reported Device Performance (FUSION Bioline vs. EXXCEL / FUSION alone)
Bench Testing: Conformance to performance specifications for various physical properties (e.g., tensile strength, kink diameter, burst strength, shear bond strength, etc.)	Bench testing performed, and results suggest conformance to specifications. No new safety or performance issues raised.
Biocompatibility: Demonstrated biocompatibility.	Biocompatibility testing performed. No details on specific acceptance criteria or results are provided, but the submission implies satisfactory outcomes.
Animal Studies: Acceptable vascular compatibility, patency, and tissue response.	Canine Study (FUSION vs. EXXCEL): Patency was comparable. Healing process was comparable, with benign healing response and no safety concerns. Porcine Study (FUSION vs. FUSION Bioline; FUSION Bioline vs. GORE PROPATEN): Comparable surfaces between FUSION and FUSION Bioline, similar to EXXCEL. FUSION Bioline vs. GORE PROPATEN showed widely patent grafts and similar tissue response.
Clinical Efficacy (Primary Patency at 6 months for FUSION Bioline): Non-inferiority to EXXCEL with a predefined margin.	FUSION Bioline vs. EXXCEL (Randomized Multicenter Trial): Primary patency at 6 months for FUSION Bioline was 86.4% vs. 70.0% for EXXCEL. Difference was 16.4%, with a non-inferiority p-value of

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