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The Artix BG balloon thrombectomy sheath is indicated for:

• · The non-surgical aspiration of emboli and thrombi from blood vessels.
• · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
• · Use as a conduit for retrieval devices.
• · Use in facilitating the insertion and quidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

The Artix BG balloon thrombectomy sheath is intended for use in the peripheral vasculature.

The Artix BG is a single-use, over-the-wire system designed to aspirate thrombi and emboli from the peripheral vasculature, facilitate the insertion and guidance of an intravascular catheter into selected peripheral blood vessels, and act as a conduit for retrieval devices. A compliant balloon mounted at the sheath's distal tip provides temporary vascular occlusion during angiographic and interventional procedures. The Artix BG is also capable of infusion/aspiration of fluids into or from a selected vessel. The Artix BG is packaged with the following components: Artix BG balloon thrombectomy sheath (8 Fr, 65 cm or 105 cm) 8 Fr Introducer Dilator (0.014" and 0.035" guidewire compatibility) Balloon Inflation Syringe, 1 mL Large Bore Syringe, 30 mL 3-way Stopcock

The provided text is a 510(k) summary for the Inari Medical Artix BG device. This document is a regulatory submission for medical devices to the FDA, demonstrating substantial equivalence to a legally marketed predicate device.

Crucially, this document does not describe a study proving the device meets acceptance criteria in the context of comparing its performance to a defined set of clinical or technical metrics for a novel technology.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared device (Inari Medical, Artix BG K223000) based on a device modification (addition of two alternate suppliers for the PTFE liner). Therefore, the "acceptance criteria" and "study" described in the prompt are not applicable in the way they would be for a direct performance validation of a new device.

Here's an breakdown based on the information provided, highlighting why it doesn't fit the typical "acceptance criteria and study" mold for a new device's performance:

1. Table of acceptance criteria and the reported device performance:

This document doesn't provide a table of acceptance criteria and device performance in the sense of clinical metrics (e.g., sensitivity, specificity, accuracy, or a specific functional performance threshold for a new technology).

Instead, the document's "acceptance criteria" is implicitly demonstrating that the modified device (Artix BG with new PTFE suppliers) performs equivalently to the predicate device (the original Artix BG). The "reported device performance" is that the modified device "continues to apply" to previous performance test results.

• Acceptance Criteria (Implied): The modified device must perform equivalently to the predicate device, as demonstrated through non-clinical testing. This means:
  • No change in intended use, design, fundamental scientific technology, or principles of operation.
  • Meeting biocompatibility requirements per ISO 10993-1.
  • Maintaining sterility assurance level (SAL) of 10-6.
• Reported Device Performance:
  • "As there were no proposed design changes, previous performance test results that demonstrated that all acceptance criteria were met continue to apply; therefore, the device conforms to established product specifications."
  • Biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility (Hemolysis)) were completed and passed.
  • Sterilization using EtO to achieve SAL of 10-6 was validated.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for specific non-clinical tests. The statement "previous performance test results that demonstrated that all acceptance criteria were met continue to apply" implies reliance on prior testing of the original Artix BG device. For the biocompatibility tests, typically a sufficient number of samples are used to meet the standards (e.g., ISO 10993-1), but the exact numbers are not provided.
• Data Provenance: Not specified. The document is a regulatory submission to the FDA, likely based on internal company testing or contracted lab testing. It's not clinical data (retrospective or prospective) in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. This document refers to non-clinical (laboratory/bench) testing and substantial equivalence, not a clinical study requiring expert ground truth for interpretation of outcomes. Biocompatibility and sterility testing follow established international standards and protocols, not expert consensus on medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• N/A. This applies to clinical studies or studies involving human assessment of data. The testing mentioned in this document is non-clinical.

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:

• N/A. This is a non-clinical device modification submission, not an AI or imaging diagnostic study.

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

• N/A. This is not an AI or algorithm-based device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• N/A (for clinical ground truth). The "ground truth" for the non-clinical tests would be the established scientific methods and standards (e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterilization) that define what constitutes a "passing" or "acceptable" result for each test.

8. The sample size for the training set:

• N/A. This is not an AI or machine learning device requiring a training set.

9. How the ground truth for the training set was established:

• N/A. This is not an AI or machine learning device.

Summary of the "Study" provided in the document:

The "study" or rather the evidence provided to support substantial equivalence after the modification (new PTFE suppliers) primarily consists of:

• Non-Clinical Testing: The document states that "previous performance test results...continue to apply" due to "no proposed design changes" affecting those aspects.
• Biocompatibility Testing:
  • Tests conducted: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemocompatibility (Hemolysis).
  • Proof: Passing results demonstrated meeting biological safety requirements per ISO 10993-1.
• Sterilization Validation:
  • Method: EtO sterilization to achieve a sterility assurance level (SAL) of 10-6.
  • Proof: Validated process in accordance with ISO 11135:2014/Amd 1:2018 and AAMI TIR 28:2016.

Conclusion from the document:

"The Artix BG has the same intended use/indications for use and principles of operation as the predicate. The testing provided supports the Artix BG's substantial equivalence to the predicate device."

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The Artix BG balloon thrombectomy sheath is indicated for:
• Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The balloon provides temporary vascular occlusion during these and other angiographic procedures.
• Use as a conduit for retrieval devices.
• The non-surgical aspiration of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The Artix BG balloon thrombectomy sheath is intended for use in the peripheral vasculature.

The Artix BG is a single-use, over-the-wire system designed to facilitate the insertion and guidance of an intravascular catheter into a selected peripheral blood vessel and act as a conduit for retrieval devices. A compliant balloon mounted at the sheath's distal tip provides temporary vascular occlusion during angiographic and interventional procedures. The Artix BG also non-surgically aspirates thromboemboli from selected vessels and is capable of infusion/aspiration of fluids into or from a selected vessel. The Artix BG is packaged with the following components:
• Artix BG balloon thrombectomy sheath (8 Fr, 65 cm or 105 cm)
• 8 Fr Introducer Dilator (0.014" and 0.035" guidewire compatibility)
• Balloon Inflation Syringe, 1 mL
• Large Bore Syringe, 30 mL
• 3-way Stopcock

The Artix BG is comprised of a single through lumen shaft with four (4) embedded lumens for balloon inflation and deflation, a proximal integrated hemostasis valve to minimize blood loss, a stopcock with flush port, and a balloon port. To assist with insertion of the sheath into the vasculature, a hydrophilic coating covers a portion of the distal sheath shaft. The distal tip of the sheath shaft contains two (2) radiopaque marker bands to aid with angiographic visualization: The distal marker indicates the location of the sheath's tip, while the proximal marker band marks the location of a compliant balloon mounted at the distal end. The balloon provides temporary vascular occlusion during angiographic and interventional procedures.

The provided text is a 510(k) summary for the Inari Medical Artix BG balloon thrombectomy sheath. It describes the device, its indications for use, and a comparison to predicate and reference devices. It also outlines the non-clinical testing performed to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for the non-clinical tests (Sheath Visual & Dimensional, Simulated Use Cycling, Sheath Aspirational Flowrate, Clot Burden Removal). It only mentions that "verification and validation testing were identified."

The data provenance is not specified regarding country of origin, but it is clear these were pre-market, non-clinical tests as indicated by "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." This implies the tests were conducted in a lab setting by the manufacturer, Inari Medical.

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

Not applicable. The tests performed are non-clinical engineering and performance tests, not studies requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are non-clinical engineering and performance tests, not studies requiring expert 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

Not applicable. This device is a medical instrument (balloon thrombectomy sheath), not an AI/software as a medical device (SaMD) that would typically undergo MRMC studies involving human readers.

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

Not applicable. This device is a medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was adherence to established product specifications and recognized international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135 and AAMI TIR 28 for sterilization). For tests like "Sheath Visual & Dimensional" or "Sheath Aspirational Flowrate," the ground truth would be the engineering specifications the device was designed to meet.

8. The Sample Size for the Training Set

Not applicable. This device is a medical instrument, not a machine learning algorithm that requires a training set.

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

Not applicable. As above, this is not an AI/ML device.

In summary, the provided document focuses on non-clinical testing to establish substantial equivalence for a medical device (Artix BG balloon thrombectomy sheath). The "study" proving the device meets acceptance criteria consists of various engineering and performance tests, biocompatibility assessments, and sterilization validation. These tests were conducted against pre-defined product specifications and international standards, and all were reported as successfully meeting their respective acceptance criteria.

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