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The Transjugular Liver Access Sets are comprised of various components that facilitate transjugular access to the liver for the purpose of performing diagnostic and interventional procedures. The sets are grouped into two basic types: the Ring Transjugular Intrahepatic Access Set and the Rösch-Uchida Transjugular Liver Access Set. Each set includes a core component comprised of a combination of either a stiffening cannula/Teflon catheter or needle stylet/Teflon catheter that facilitates access into the hepatic vasculature and the creation of a pathway into the portal vein. Other components included in some of these sets are a Check-Flo Introducer Set. selective catheters, and wire guides.

AI/ML Overview

The Transjugular Liver Access Sets were evaluated through various performance and biocompatibility tests. The sections below outline the acceptance criteria and the study details.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Test Name	Acceptance Criteria	Reported Device Performance
Biocompatibility	Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility (Hemolysis, Complement Activation, In Vivo Thrombogenicity), Material-mediated Pyrogenicity	Met ISO 10993-1 and FDA guidance criteria; device is biocompatible.	All test results met the acceptance criteria or demonstrated that the device is biocompatible.
Performance - Core Components	Radiopacity	Visible in radiographic image and qualitatively assessed as non-inferior to user-defined standard (following ASTM F640-12).	Demonstrated that the devices were visible in the radiographic image and were qualitatively assessed to be non-inferior to the user-defined standard, following the method described in ASTM F640-12.
	Corrosion Resistance	No effect on the functional performance of the components.	Demonstrated that there is no effect on the functional performance of the components.
	Tensile Testing	Met acceptance criteria per applicable ISO and JIS standards.	Demonstrated that the devices met the acceptance criteria.
	Torque	Peak torque within clinical requirement.	Demonstrated that the peak torque was within the clinical requirement.
	Liquid Leakage, Air Leakage, Burst Pressure	Met acceptance criteria per test method described in relevant annexes of ISO 10555-1:2013.	Met the acceptance criteria.
	Resistance to Breakage	Met acceptance criteria per test method described in Annex C of BS EN ISO 9626.	Demonstrated that the test articles met the acceptance criteria.
Performance - Additional Set Components	Dilator Hub-to-Shaft Tensile	Peak load of hub-to-shaft greater than or equal to 15N (in accordance with BS EN ISO 11070).	Showed the peak load of the hub-to-shaft were greater than or equal to 15N.
	Wire Guide Tensile Testing	Met pre-determined acceptance criteria (in accordance with ISO 11070:2014, Annex H).	Showed that the pre-determined acceptance criteria were met.
	Wire Guide Corrosion Testing	Met pre-determined acceptance criteria (in accordance with Annex B of ISO 11070:2014).	Demonstrated that the pre-determined acceptance criteria were met.
	Wire Guide Flexing Test	Met pre-determined acceptance criteria (in accordance with Annex G of ISO 11070:2014).	Demonstrated that the pre-determined acceptance criteria were met.
	Wire Guide Fracture Testing	Met pre-determined acceptance criteria (in accordance with Annex F of ISO 11070:2014).	Demonstrated that the pre-determined acceptance criteria were met.
	Wire Guide Torque Strength Testing	Characterization performed in accordance with FDA Coronary and Cerebrovascular Guidewire Guidance (1995).	Characterization testing performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
	Wire Guide Tip Flexibility Characterization	Characterization performed in accordance with FDA Coronary and Cerebrovascular Guidewire Guidance (1995).	Characterization testing performed in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
General Assessment	Dimensional, Surface, and Compatibility Analysis	Critical dimensions met predefined acceptance criteria, surfaces were free from defects, and set components were compatible.	Performed on all components to verify that the critical dimensions met the predefined acceptance criteria, that the surfaces of the devices were free from defects, and that the set components were compatible.

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

The document does not explicitly state the exact sample sizes used for each individual test. It mentions "all components of the subject device or on representative devices" for biocompatibility testing and refers to "the components in the subject device" and "the test articles" for performance testing. The provenance of the data (country of origin, retrospective or prospective) is not specified, but the tests were conducted by "Cook Incorporated" and referenced international standards (ISO, JIS, BS EN ISO) and FDA guidance.

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

This information is not applicable to the type of device and testing described. The tests performed are laboratory-based physical and chemical property assessments, not diagnostic or interpretive tasks requiring expert human readers to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. The tests are objective measurements against defined acceptance criteria, not subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed. The device is a medical instrument (catheter introducer set), and the testing focused on its physical properties and biocompatibility, not on a human-in-the-loop diagnostic or therapeutic performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

This information is not applicable. The device is a physical medical instrument, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for the acceptance criteria was established through:

International Standards: ISO 10993-1, ASTM F640-12, ISO 10555-1:2013, BS EN ISO 9626, BS EN ISO 11070, ISO 11070:2014.
FDA Guidance: General FDA guidance documents and specifically the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
User-Defined Standards and Clinical Requirements: For tests like radiopacity (non-inferior to user-defined standard) and torque (within clinical requirement).
Predefined Acceptance Criteria: For dimensional analysis and other performance tests.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not an AI or algorithm-based system that requires a "training set."

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

This information is not applicable as there is no training set for this device.

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