FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The GORE® ACUSEAL Vascular Graft is a multilayer graft design comprised of expanded polytetrafluoroethylene (ePTFE) separated by an elastomeric layer and may be available both with and without covalently bound bioactive heparin on the luminal surface of the device (commonly known as the Carmeda® BioActive Surface, or CBAS® heparin). The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.

AI/ML Overview

The GORE® ACUSEAL Vascular Graft is primarily intended for use as a vascular prosthesis in patients requiring vascular access. The device demonstrated substantial equivalence to predicate devices through in vitro, in vivo animal, and in vivo clinical testing.

Here's an analysis of the acceptance criteria and the studies that prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Endpoint)	Performance Criterion / Historical Control	Reported Device Performance (GORE® ACUSEAL)	Notes
In Vivo Animal Testing (Canine Model)
Intra-Operative Suture Line Bleeding	Equivalent to currently marketed devices	No intra-operative suture line bleeding	This suggests excellent initial hemostasis at the surgical site.
Post-Cannulation Time-to-Hemostasis	Comparable to or significantly lower than predicate devices	Comparable to or significantly lower than predicate devices	Indicates effective sealing after needle punctures, crucial for vascular access devices.
Device Patency	Remains patent and in position	Remained widely patent throughout the in-life period	Angiographic imaging confirmed sustained blood flow. CT scans showed no kinking.
Histological Response	Similar to currently marketed grafts	Comparable to predicate vascular grafts	Evaluates tissue integration and inflammatory response; a comparable response indicates good biocompatibility.
In Vivo Clinical Trial (Human)	Historical Control	GORE® ACUSEAL	Interpretation
Primary Efficacy: Cumulative Patency at 6 months	75%	84%	GORE® ACUSEAL demonstrated superior cumulative patency, exceeding the historical control.
Secondary Efficacy: Primary Unassisted Patency	42%	46%	Slightly improved primary unassisted patency, although the document states "comparable."
Primary Safety: Freedom from Bleeding at 6 months	78%	88%	GORE® ACUSEAL demonstrated superior freedom from bleeding, exceeding the historical control. This includes major or minor bleeding events.
Time to First Cannulation (24 hours)	Not explicitly defined as a criterion	22.2% (N=30/135)	This data indicates a significant portion of grafts were cannulated quickly. Median time to first cannulation was 5 days, and for those within 24 hours, the median was 21 hours. This is a key advantage for patients requiring early dialysis.
Time to Third Consecutive Hemodialysis (within 28 days)	Not explicitly defined as a criterion	75.6%	This endpoint addresses quick reliance on the graft for dialysis, which can lead to earlier removal of temporary central venous catheters (CVCs), reducing CVC-related complications.
Device Related Adverse Events / Deaths	None	None	The absence of device-related adverse events or deaths is a strong indicator of safety.

Note: For in vitro tests (Wall Thickness, Internal Diameter, Suture Retention, Kink Radius, Punctured Burst, Punctured Leak, Burst Testing, Fibril Length, Water Entry Pressure (WEP), Tensile Strength, Pressurized Internal Diameter), the document states that results "demonstrate that the technological characteristics and performance criteria of the devices are comparable and equivalent" to predicate devices. Specific numerical acceptance criteria were not provided in the summary but were met.

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

In-Vivo Animal Study:
- Sample Size: Not explicitly stated, but the study was conducted in a "canine model" and tested "4 device attributes." Typically, these studies involve a small number of animals per test group.
- Data Provenance: Prospective, animal model (canine).
In-Vivo Clinical Trial:
- Sample Size: 138 subjects.
- Data Provenance: Multi-centered, prospective, single-arm clinical trial. The location (country of origin) is not explicitly stated, but as it's a 510(k) submission to the FDA, it's highly likely to include US-based centers. The "historical controls" data would have been derived from existing literature or internal company data from previously marketed devices.

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

In-Vivo Animal Study: Not explicitly stated. For animal studies, the "ground truth" (e.g., histological response, patency) is typically established by veterinary pathologists, surgeons, and imaging specialists. Qualifications would generally be board certification or equivalent experience in their respective fields.
In-Vivo Clinical Trial: The ground truth for endpoints such as cumulative patency, freedom from bleeding, and time to cannulation would have been established by the clinical investigators (physicians/surgeons) involved in the multi-centered trial, supported by objective measurements (e.g., hemodynamic evidence of blood flow, clinical documentation of bleeding events). Their qualifications would be as medical professionals (e.g., vascular surgeons, nephrologists) experienced in managing patients requiring vascular access for hemodialysis. The exact number of experts in each center or for overall data review is not specified.

4. Adjudication Method for the Test Set:

In-Vivo Animal Study: Not explicitly stated.
In-Vivo Clinical Trial: Not explicitly stated. For a multi-centered clinical trial, endpoints are typically defined in the study protocol, and data is collected according to these definitions. It is common for adverse events and efficacy endpoints to undergo an adjudication process by an independent clinical events committee (CEC) to ensure consistency and minimize bias, especially for subjective assessments. However, the document does not specify if such a method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This is not applicable. The GORE® ACUSEAL Vascular Graft is a physical medical device (vascular prosthesis), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers was not performed. The "readers" in this context would be the clinicians assessing the patient outcomes directly.

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

This is not applicable. As mentioned above, the GORE® ACUSEAL Vascular Graft is a physical medical device, not an algorithm or software. Its performance is evaluated based on its biological, mechanical, and clinical characteristics, not as a standalone AI system.

7. The Type of Ground Truth Used:

In-Vivo Animal Study:
- Intra-Operative Suture Line Bleeding: Direct observation by surgeons.
- Post-Cannulation Time-to-Hemostasis: Direct observation and measurement.
- Device Patency: Angiographic imaging (objective assessment of blood flow) and CT scans (objective assessment of kinking).
- Histological Response: Pathological examination of tissue samples by trained pathologists.
In-Vivo Clinical Trial:
- Cumulative Patency: Hemodynamic evidence of blood flow (objective measurement), presumably through clinical assessment, Doppler ultrasound, or angiography as per study protocol.
- Freedom from Bleeding: Clinical documentation and reporting of bleeding events (e.g., hematoma, incision site bleeding, gastrointestinal bleeding, rectal bleeding, hemoptysis).
- Time to First Cannulation: Clinical records of when the graft was first accessed.
- Time to Third Consecutive Hemodialysis: Clinical records of dialysis sessions.
- Adverse Events/Deaths: Clinical reporting and monitoring.

8. The Sample Size for the Training Set:

This is not applicable in the context of device approval for a physical medical implant. There is no "training set" in the machine learning sense. The clinical trial data for the GORE® ACUSEAL Vascular Graft serves as the evaluation set. The "training" for the device's design would come from engineering principles, pre-clinical testing, and experience with predicate devices.

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

This is not applicable as there is no "training set" for an AI model. For the development of the device itself, the "ground truth" guiding its design and iterative improvements comes from:
- Engineering specifications and material science: Based on known properties of ePTFE and elastomer.
- Bench testing data: In vitro tests (e.g., tensile strength, burst pressure) establishing mechanical properties against engineering standards and comparability to predicate devices.
- Pre-clinical animal data (prior to this specific study): Early phase animal studies to understand basic biocompatibility and performance characteristics, guiding design modifications.
- Clinical experience with predicate devices: Understanding the performance and failure modes of existing vascular grafts (GORE® PROPATEN®, GORE-TEX® Stretch, Vascutek® SEALPTFE™) informed the design of the GORE® ACUSEAL graft.

Summary

Regulation Number and Section

§ 870.3450 Vascular graft prosthesis.

(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”