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The Artix™ MT thrombectomy device is indicated for:

· The non-surgical removal 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™ MT thrombectomy device is intended for use in the peripheral vasculature.

The Artix™ Thin-Walled Sheath is indicated for:

· The non-surgical removal 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 endovascular devices.

· Use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel. The funnel provides temporary vascular occlusion during these and other angiographic procedures.

The Artix™ Thin-Walled Sheath is intended for use in the peripheral vasculature.

The Artix™ MT is a single-use, over-the-wire catheter device used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The Artix MT is packaged with the following components: Artix MT (3-6 mm or 4-8 mm) Cleaning accessory 1-Way Stopcock The Artix MT is inserted over-the-wire through a compatible sheath (such as the Artix Thin-Walled Sheath) and advanced until its proximal marker band is distal to the target thrombus. The self-expanding element is deployed by retracting the delivery catheter. Thrombus is engaged and removed by retracting the Artix MT into the sheath and out of the patient. Once the procedure is complete, the system is completely withdrawn from the patient.

The Artix™ Thin-Walled Sheath ("Artix Sheath") 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 endovascular devices. The Artix Sheath also non-surgically aspirates thromboemboli from selected vessels and is capable of infusion/aspiration of fluids into or from a selected vessel. The Artix Sheath is packaged with the following components: Artix Thin-Walled Sheath (65 cm or 90 cm) Sheath Dilator (0.035" guidewire compatibility) Funnel Catheter and Funnel Catheter Dilator (0.035" guidewire compatibility) Funnel Loading Tool (2) Large Bore Syringe, 30 mL The Artix Sheath is inserted over-the-wire and advanced to a desirable position. Any compatible endovascular device, such as the Artix MT, can then be inserted through the Artix Sheath for access into the peripheral vasculature. The provided funnel catheter accessory can also be inserted through the Sheath and deployed to provide flow occlusion of the vessel during the procedure to aid with the system's clot ingestion. Compatible endovascular devices, such as the Artix MT, can be used through the 6 Fr inner diameter of the funnel catheter as well. The provided 30 mL syringe can be used to aspirate clot in the vessel or Sheath and infuse contrast media and other fluids as required. Once the procedure is complete, the funnel catheter (if used) is removed prior to withdrawal of the entire system from the patient, and standard 7 Fr closure devices can be used.

The provided document describes the 510(k) premarket notification for two devices: Artix™ MT and Artix™ Thin-Walled Thrombectomy Sheath. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not contain information about acceptance criteria or studies involving human expert performance (such as MRMC studies, specific ground truth established by experts, or sample sizes for test/training sets relevant to AI/software performance).

Therefore, I cannot fulfill the request for information on acceptance criteria and a study proving device meets those criteria in the context of AI/software performance with human-in-the-loop. The document exclusively discusses the substantial equivalence of physical medical devices based on their design, materials, and non-clinical performance (e.g., burst strength, tensile strength, simulated use, biocompatibility).

The "study" mentioned in the document refers to a series of non-clinical tests conducted to demonstrate that the devices perform as intended and are as safe and effective as their predicate devices. These tests are not related to AI or human reader performance.

Here's an overview of the information that is available in the document, which primarily concerns the physical characteristics and performance of the devices:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present acceptance criteria in a quantitative table with reported device performance in the way one might expect for AI or software. Instead, it lists various non-clinical tests (e.g., Biocompatibility, Sterilization, Packaging Testing, Visual and Dimensional Inspections, Simulated Use Testing, Hemostasis, Burst, Corrosion, Radiopacity, Radial Force, Chronic Clot Analog for Artix MT; and similar tests for Artix Thin-Walled Sheath) and states that "The passing results demonstrate that the subject device meets biological safety requirements" (for biocompatibility) and that "verification and validation testing were identified to support the substantial equivalence" and "The testing provided supports the Artix MT's substantial equivalence." This implies that the devices met their internal acceptance criteria for these physical and functional tests. However, the specific numerical acceptance criteria and performance outcomes for each test are not detailed in this summary.

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

• Test Set (Non-clinical): The document does not specify the sample sizes for the individual non-clinical tests conducted (e.g., how many units were tested for burst strength, or simulated use).
• Data Provenance: Not applicable in the context of device performance data presented, as it refers to non-clinical, lab-based testing of the physical devices.

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

• Not applicable. The "ground truth" for the performance of these physical medical devices is established through engineering specifications, material science, and physical testing protocols, not through expert consensus on interpretation of medical images or patient outcomes.

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

• Not applicable. This concept typically applies to human reader studies where disagreements in interpretations need to be resolved. For non-clinical device testing, results are typically objective measurements against pre-defined specifications.

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:

• No. The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." This means no human-in-the-loop or clinical studies were performed or are discussed here. MRMC studies are not relevant to this submission.

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

• Not applicable. These are physical thrombectomy devices, not AI algorithms.

7. The type of ground truth used:

• For the non-clinical tests ("verification and validation testing"), the "ground truth" is defined by engineering specifications, material properties, and performance benchmarks established through industry standards and the predicate device's known performance. For example, a "burst" test would have a pre-defined pressure or force target that the device must withstand to pass.

8. The sample size for the training set:

• Not applicable. This concept is for machine learning models. These devices are physical products.

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

• Not applicable.

In summary, the provided FDA 510(k) summary is for physical medical devices and does not describe acceptance criteria or studies related to AI performance or human reader studies. The "studies" mentioned are non-clinical verification and validation tests to ensure the physical device meets its design specifications and is substantially equivalent to existing predicate devices.

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The RevCore Thrombectomy Catheter is indicated for:
• The non-surgical removal of thrombi and emboli from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The RevCore Thrombectomy Catheter is intended for use in the peripheral vasculature.

The RevCore Thrombectomy Catheter is a single-use, sterile medical device designed for use in the peripheral vasculature. The RevCore Thrombectomy Catheter comprises reinforced polymeric and metal coaxial shafts terminating in an expandable coring element. Two ports are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the RevCore Thrombectomy Catheter distal tip and coring element are radiopaque. The RevCore Thrombectomy Catheter consists of a distal laser-cut nitinol coring element, catheter shafts, and a handle, providing wall-to-wall contact, allowing the engagement and retrieval of clot from blood vessels and from implanted venous stents. The catheter shafts introduce the nitinol coring element percutaneously. The handle allows the physician to retract and turn the nitinol coring element to engage clot, as well as control the diameter of the nitinol coring element with a knob.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: RevCore™ Thrombectomy Catheter

The document states that the RevCore Thrombectomy Catheter underwent various performance, biocompatibility, and sterilization tests to demonstrate substantial equivalence to its predicate and reference devices. However, it does not explicitly provide a table of acceptance criteria with corresponding performance results for each test. Instead, it lists the types of tests performed and generally states that "acceptance criteria were met."

Therefore, I will create a table summarizing the types of tests performed and the general statement about their success.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

• Pouch Dye Penetration
• Pouch Bubble Leak
• Aseptic Presentation | All non-clinical test results demonstrated that acceptance criteria were met. |
  | Dimensions & Key Characteristics | - Visual and Dimensional Inspections (RevCore Catheter, RevCore Coring Element, RevCore Delivery Catheter)
• Guidewire Compatibility | All non-clinical test results demonstrated that acceptance criteria were met. |
  | Performance & Functional Evaluation| - Deairing/Flushing Testing
• Knob Torque Testing
• Deployment and Retraction Force through the Delivery Catheter
• Coring Element Retraction into Delivery Catheter Inspection
• Distal Catheter Kink Radius Testing
• Coring Element Durability Inspection (Post-Simulated Use)
• Insertion through Sheath
• Retraction Force through Sheath
• Sheath Inspection (Post-Simulated Use)
• Leakage Testing, Sheath (Post-Simulated Use)
• Vacuum Testing, Sheath (Post-Simulated Use)
• Leakage Testing, RevCore Catheter (Post-Simulated Use)
• Delivery Catheter Durability Inspection (Post-Simulated Use)
• Simulated Use Tracking and Tensile Testing (Post-Simulated Use)
• Simulated Use Tracking and Torque Testing (Post-Simulated Use)
• Corrosion Testing
• Particulate Matter Determination
• Luer Testing
• Safety Testing in Stent Model | All non-clinical test results demonstrated that acceptance criteria were met. |
  | Characterization Tests | - Radial Force Characterization
• Efficacy Testing (Clot & Stent Model)
• SEM of Stents/RevCore Coring Elements Post-Treatment | All non-clinical test results demonstrated that acceptance criteria were met. |
  | Leveraged Tests | - Pouch Seal Strength
• Simulated Use Tracking and Rotation Testing
• Delivery Catheter Radiopacity | All non-clinical test results demonstrated that acceptance criteria were met. |
  | Pre-Clinical Study | - GLP Animal Study (to evaluate safety and performance) | The GLP animal testing met the predetermined acceptance criteria. |
  | Biocompatibility | - Cytotoxicity
• Sensitization
• Intracutaneous Reactivity
• Acute Systemic Toxicity
• Pyrogenicity (Material Mediated)
• Hemocompatibility (Hemolysis, Complement Activation, Thrombogenicity, Platelet and Leukocyte, Partial Thromboplastin Time (PTT)) | All non-clinical test results demonstrated that acceptance criteria were met. |
  | Sterilization | - Sterilization using EtO to achieve a sterility assurance level (SAL) of 10^-6 in accordance with ISO 11135:2014 and AAMI TIR 28:2016. | Successfully achieved SAL of 10^-6 without deviations. |

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

The document does not provide specific sample sizes for each of the listed tests (e.g., number of catheters tested for durability, number of animals in the GLP study).

• Sample Sized Used for the Test Set: Not specified in detail for individual tests. A "GLP Animal Study" was performed, implying animal subjects were used, but the number is not provided.
• Data Provenance: The studies are described as "non-clinical performance testing" and a "Pre-Clinical Study (GLP Animal Study)," indicating experimental lab/animal data rather than human patient data, and thus no country of origin is specified in that context. The context is a regulatory submission to the FDA in the US.

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

This information is not applicable and not provided. The testing described is performance, preclinical animal, and biocompatibility testing for a medical device, which typically relies on established laboratory protocols, measurement standards, and animal models rather than expert consensus on ground truth in the context of imaging or diagnostic AI.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving human review of data (e.g., medical images) to establish ground truth or resolve discrepancies. The provided document describes device performance and preclinical animal testing.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. Such studies are typically conducted for diagnostic devices or AI algorithms that involve human interpretation, to assess the impact of the device on reader performance. This document pertains to a thrombectomy catheter, which is an interventional device, not a diagnostic one involving human readers for interpretation.

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

This question is not applicable as the device described is an interventional medical device (thrombectomy catheter), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

For the performance and functional tests, the "ground truth" would be established engineering specifications, material properties, and predetermined acceptance thresholds for various physical and mechanical properties. For the GLP Animal Study, the "ground truth" would be the observed safety and performance outcomes against predefined endpoints in the animal model. For biocompatibility, the ground truth is established by adherence to ISO 10993-1 standards and the specific metrics of those tests (e.g., cytotoxicity levels, hemocompatibility parameters).

8. The Sample Size for the Training Set

This question is not applicable as the device described is a physical medical device, not an AI or machine learning model that requires a training set.

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

This question is not applicable as the device described is a physical medical device, not an AI or machine learning model.

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The FlowTriever Retrieval/Aspiration System is indicated for:

• The non-surgical removal 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 FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately:
• Triever Catheters (available in 3 sizes: 16, 20 (and 20 Curved) and 24 Fr)
• FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm)
Triever Catheters (Triever 16, Triever 20, Triever 20 Curve, and Triever 24) are inserted and advanced to the thrombus over a pre-placed 0.035" guidewire. After removal of its dilator, thrombus may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter is removed from the patient.

This document is a 510(k) summary for a medical device (FlowTriever Retrieval/Aspiration System) and describes updates to its indications for use. It is not a study report proving the device meets acceptance criteria through performance evaluation.

Therefore, I cannot provide the requested information as the document does not contain a study that demonstrates device performance against specific acceptance criteria.

The submission focuses on a modification to the contraindications for the device, specifically removing "chronic clot" from the examples of material not to be removed. The core of this 510(k) summary is to demonstrate that this change does not raise new questions of safety or effectiveness compared to the predicate device.

The document explicitly states:

• "Non-Clinical Testing Non-clinical testing was not required to support the change to the contraindications."
• "Clinical Testing No clinical data was required to support the change to the contraindications."

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