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The Endologix AFX Introducer System is intended for use to facilitate the introduction of guidewires, catheters, and other medical devices into the vasculature and minimize blood loss associated with such introduction.

The Endologix AFX Introducer System, Model S17-45 consists of an Introducer Sheath (45cm working length), Dilator, and a peel-away wire straightener. The AFX Introducer System is a single-use sterile device that is compatible with a standard 0.035" guidewire.

This document describes a Special 510(k) submission for the Endologix AFX Introducer System, Model S17-45, which involves a minor modification to an already cleared device. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device rather than presenting a de novo clinical study with extensive acceptance criteria and performance metrics typically associated with novel devices or significant device changes.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Implied Acceptance Criteria: For a Special 510(k) submission involving a minor modification to an already cleared device, the "acceptance criteria" are primarily based on demonstrating that the modification does not negatively impact the safety and effectiveness of the device compared to the predicate. This is typically achieved by performing specific tests against recognized standards and ensuring the modified device continues to meet the performance characteristics established for the predicate. Specific numerical performance metrics are usually not presented as "acceptance criteria" in this context unless the modification specifically impacts a measurable performance claim.

Study Type: This is not a clinical study on patient outcomes or a comparative effectiveness study in the traditional sense. It's a bench testing and validation study designed to demonstrate that the changes (replacement of a butyl rubber valve with a silicone valve, modification of hemostasis valve housing, and addition of a peel-away wire straightener) to the AFX Introducer System maintain the device's substantial equivalence to its predicate device (K111747).

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

• Test Set Sample Size: The document does not specify the exact sample sizes used for each individual test (e.g., number of devices tested for functional or mechanical qualification). This is typical for such submissions as the focus is on confirming adherence to established standards rather than statistical clinical significance.
• Data Provenance: The data provenance is from bench testing conducted by Endologix, Inc. to assess various aspects of the modified device against recognized industry standards. The country of origin of the data is Endologix, Inc. (Irvine, CA, USA). The data is prospective in the sense that the tests were specifically performed after the device modification to validate its performance.

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

• Number of Experts: Not applicable in the context of this submission. "Ground truth" for bench testing is established by the specifications of the device and the requirements of the applicable test standards. The tests are designed to objectively measure specific characteristics.
• Qualifications of Experts: The testing would have been conducted by trained engineers and technicians at Endologix, Inc., with expertise in medical device testing and quality assurance, and familiarity with the relevant ISO and AAMI standards.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where expert consensus is needed to establish a "true" diagnosis or outcome for a patient. In bench testing, the results are objectively measured against pre-defined criteria from the standards. Any discrepancies would be handled through a formal investigation process.

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

• No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers (e.g., radiologists) perform with and without an AI assistant across multiple cases. The submission is for a physical medical device (introducer system) and does not involve AI or human interpretation of outputs that would warrant an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, a standalone (algorithm only) performance study was not done. This concept applies to AI/ML software devices. The Endologix AFX Introducer System is a physical medical device and does not inherently have an "algorithm-only" or "human-in-the-loop" component in this context.

7. The Type of Ground Truth Used

• Ground truth for bench testing: The "ground truth" for the tests performed (Functional/Mechanical Qualification, Sterilization Validation, Biocompatibility) is defined by the requirements and specifications within the referenced international consensus standards (BS EN ISO 10555-1:2009, ANSI/AAMI/ISO 11135-1: 2007, AAMI TIR 28: 2009, ISO 10993-1: 2009) and the design specifications of the Endologix AFX Introducer System. The tests were performed to demonstrate compliance with these objective standards.

8. The Sample Size for the Training Set

• Not applicable. This submission is for a physical medical device. The concept of a "training set" is relevant for AI/ML models.

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

• Not applicable. As stated above, there is no training set for this device.

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The Endologix AFX Introducer Systems are intended for use to facilitate the introduction of guidewires, catheters, and other medical devices into the vasculature and minimize blood loss associated with such introduction.

The Endologix AFX Introducer Systems consist of an Introducer Sheath (45 cm working length) and either one or two Dilators. Model S17-45DD contains dual dilators: a dual-lumen dilator for introduction and management of two guidewires; and, a single-lumen dilator. Model S17-45 contains only the single-lumen dilator.

Each AFX Introducer System is enclosed in a sterile package. Each system is compatible with a standard 0.035" guidewire.

• 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 Vectrands for increased longitudinal strength. The distal tip of the introducer sheath includes an embedded radiopaque marker composed of 90% Platinum/10% Iridium. There are no changes to the Introducer Sheath from that cleared under K110090.
• Dilators: The dilators for these systems 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 Systems and can accommodate a 0.035" guidewire through the central lumen. One dilator is a single lumen device and the other dilator is a dual lumen device. Both dilators are composed of 63D Pebax with 30% 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 standard vascular access. There are no changes to the Dilators from that cleared under K110090. Model S17-45 contains only the single lumen dilator; Model S17-45DD contains both dilators with the AFX Introducer System within the package.

The provided text describes a 510(k) submission for the Endologix AFX Introducer System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study proving device performance against specific acceptance criteria.

Therefore, many of the requested categories for a study report on acceptance criteria cannot be directly addressed from the provided document. The document lists performance tests conducted to establish equivalence, not to meet specific clinical performance acceptance criteria in the manner of a standalone study for a new device's efficacy or safety.

Here's an attempt to extract relevant information and explain where the document does not provide the requested details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense for clinical performance. Instead, it lists tests performed to establish equivalence to a predicate device. The "reported device performance" in this context refers to the successful completion of these tests in accordance with the listed standards, thus demonstrating equivalence and safety/functionality.

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

• Sample Size for Test Set: Not specified. The document refers to "functional qualification" and other testing but does not provide details on the number of devices or components sampled for these tests.
• Data Provenance: The tests were conducted to support a 510(k) submission to the FDA for a device manufactured by Endologix, Inc. in Irvine, CA, USA. The data would be considered internal company testing. The document does not specify if the tests were prospective or retrospective in the clinical study sense; rather, they are part of the device development and validation process.

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

• Not applicable. This information is typically relevant for clinical studies involving expert interpretation (e.g., image analysis, diagnoses). The tests described (functional, sterilization, packaging, biocompatibility) are laboratory-based and do not involve human expert "ground truth" establishment in this manner. Evaluation is against defined technical standards and specifications.

4. Adjudication Method for the Test Set

• Not applicable. As above, adjudication methods are typically used in clinical studies for resolving discrepancies in expert interpretations. The device tests described are objective, pass/fail evaluations against technical standards.

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

• No, an MRMC comparative effectiveness study was not done. The document describes a 510(k) submission focused on demonstrating substantial equivalence through technical and functional testing, not a clinical study comparing human reader performance with and without AI.

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

• Not applicable. The Endologix AFX Introducer System is a physical medical device (introducer sheath and dilators) and does not involve an algorithm or AI. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

• Technical standards and specifications. For the tests listed, the "ground truth" is defined by the requirements outlined in the applicable ISO and AAMI standards (e.g., ISO 10555-1 for functional aspects, ISO 10993-1 for biocompatibility). Successful completion of these tests means the device met the objective criteria set by these standards.

8. Sample Size for the Training Set

• Not applicable. As this is a physical medical device and not an AI/algorithm, there is no "training set."

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

• Not applicable. (See point 8).

In summary, the provided text is a 510(k) summary for a medical device that demonstrates substantial equivalence to a predicate device through engineering and laboratory testing. It is not a report on a clinical trial with acceptance criteria for clinical efficacy or diagnostic performance, which would typically involve details about human experts, ground truth, and study designs like MRMC or standalone performance.

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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.

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