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The AFX Introducer System facilitates the introduction of guidewires, and other medical devices into the vasculature and minimizes blood loss associated with such introduction.

The Endologix AFX Introducer System consists of an Introducer Sheath (45 cm working length) and two Dilators. The system is enclosed in a sterile package. During clinical use, the system will allow introduction of a standard 0.035" guidewire within its inner lumen.

Introducer Sheath: The Introducer Sheath provides a conduit for introducing other interventional devices, including guidewires and interventional catheters, into the vasculature. The main components of this assembly are a hydrophilically-coated, PTFE lined, 55D Pebax introducer sheath, acrylobutylstyrene (ABS) hemostasis valve housing with butyl rubber valve, and silicone gasket assembly, 3 way stopcock/valve, and sideport diethylhexyl phthalate (DEHP)-free polyvinylchloride (PVC) tubing. The Pebax introducer sheath also includes an embedded stainless steel braid for increased strength and kink resistance, and embedded Vectran® strands for increased longitudinal strength. The distal tip of the introducer sheath includes an embedded radiopaque marker composed of 90% Platinum/10% Iridium.

Dilators: The dilators for the system are used to provide support and stability to the Introducer Sheath during deployment into the vasculature. The dilators are designed specifically for the Endologix AFX Introducer System and can accommodate a 0.035" guidewire through the central lumen. Two dilators are included with the AFX Introducer System. Both dilators are included within the package. One dilator is a single lumen device and one dilator is a dual lumen device. Both dilators are composed of 63D Pebax with 20% Barium Sulfate (BaSO4) for radiopacity and include a hydrophilic coating on the outer surface. These dilators are designed in diameter and length to be placed within the AFX Introducer Sheath component. The dilators have a tapered, atraumatic distal tip. The proximal end of the dilators includes a luer port. The dilators provide stiffness to the assembly so that the introducer sheath can be placed within the vasculature during a standard vascular access.

The provided document describes the Endologix AFX Introducer System, an introducer sheath and dilator system. The information outlines various tests conducted to demonstrate the device's substantial equivalence to predicate devices, focusing on regulatory and performance aspects.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document presents several tables detailing various tests performed on the Endologix AFX Introducer System. The "Result (Pass/Fail)" column serves as the reported device performance against the implied acceptance criteria for each test.

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

The document does not explicitly state the specific numerical sample sizes (e.g., how many devices were tested for leak testing or biocompatibility). Instead, it uses phrases like "All samples passed" for some performance tests, implying that an appropriate number of units were tested.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. These are standard laboratory and engineering tests, typically conducted by the manufacturer as part of the device development and regulatory submission process.

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

This section is not applicable to the provided document. The tests performed are purely engineering, materials science, and biological safety evaluations for a medical device. They do not involve interpretation of medical images or data by human experts for ground truth establishment. Therefore, there are no "experts" in the context of clinical interpretation, nor is there "ground truth" to be established by them in this type of submission.

4. Adjudication Method for the Test Set

This section is not applicable. The tests involve objective measurements (e.g., passed/failed, numerical results for strength/leakage, etc.), not subjective assessments requiring adjudication.

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

This section is not applicable. The document describes a physical medical device (introducer system), not an AI-powered diagnostic or interpretive tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

This section is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

For the engineering and biocompatibility tests, the "ground truth" is defined by established industry standards, regulatory guidelines (e.g., ISO, ASTM, USP), and internal product specifications. For instance:

• Sterility: SAL of 10^-6 as per ISO 11135-1.
• Packaging: Integrity and strength as per ISO 11607-1, ASTM F2096-04, ASTM F1929-98, ASTM F88M-09.
• Biocompatibility: Established biological responses and lack of toxicity as per ISO 10993 series.
• Performance: Physical and mechanical properties meeting requirements of ISO 10555-1 and ISO 25539-1 (e.g., no leaks at 3.0 PSI, sufficient bond strength, specific particle size limits, acceptance of 0.035" guidewire, no kinking at 90°).

These standards and specifications serve as the "ground truth" or acceptance criteria against which the device's performance is measured.

8. The Sample Size for the Training Set

This section is not applicable. The submission pertains to a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This section is not applicable for the same reasons as above.

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