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The Expanse FLOWRUNNER Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

The Expanse FLOWRUNNER Aspiration System is a peripheral thrombectomy system consisting of several components:

• FLOWRUNNER Aspiration Catheter
• FLOWRUNNER Aspiration Sheath
• Vacuum Fitting
• High Flow Stopcock Connector
• Y-Connector with Hemostatic Valve
• Hand Actuator Clip

The FLOWRUNNER Aspiration System is designed for the minimally invasive removal of thrombus from the peripheral vasculature using aspiration. The system has demonstrated compatibility with standard vascular implants, including stents and filters. It is a single use, over-the-wire, catheter-based system with the ability to infuse fluid. The FLOWRUNNER Aspiration System consists of one aspiration catheter, one aspiration sheath, one vacuum fitting, one high flow stopcock connector, one Y-connector with hemostatic valve, and a hand actuator clip.

The FLOWRUNNER Aspiration System is introduced to the site of the primary occlusion. The Aspiration Catheter is advanced through the Aspiration Sheath and targets aspiration directly to the thrombus. The Aspiration Catheter is then retracted back into the Aspiration Sheath. This process of extension and retraction of the Aspiration Catheter is then repeated to fully aspirate the clot. Suction is applied directly to the Aspiration Catheter from an external vacuum source to aspirate thrombus from an occluded vessel (maximum pressure -27.6 in Hg and minimum pressure of -8.0 in Hg).

Sterile saline flows through the Aspiration Sheath and into the Aspiration Catheter when connected proximally. No saline is injected into the patient during aspiration. The Aspiration Catheter and Sheath are visible under fluoroscopy. The hand actuator is an optional, proximal clip attached to the Aspiration Catheter to assist the user.

The FLOWRUNNER Aspiration System comes in 12F, 14F compatible diameters and 60cm, 80cm, 100cm and 120cm lengths.

The provided FDA 510(k) clearance letter and summary for the FLOWRUNNER Aspiration System are for a medical device (an embolectomy catheter), not an AI/ML powered device. As such, the document does not contain information typically found in submissions for AI/ML devices regarding acceptance criteria, study design for AI performance, ground truth, or expert involvement in classification.

The information provided focuses on the FLOWRUNNER Aspiration System's equivalence to a predicate device (ICE Aspiration System) for its intended use in removing emboli and thrombi from peripheral vessels. The "performance data" section refers to bench testing, which is standard for hardware medical devices, not AI/ML performance metrics.

Therefore, I cannot extract the requested information about acceptance criteria, study details, human reader improvement with AI, standalone performance, ground truth establishment, or training set size. This document does not describe a study involving AI/ML.

Here's a summary of what information can be extracted from the document, related to its non-AI performance claims:

1. A table of acceptance criteria and the reported device performance:

The document summarizes the performance testing generically as "Bench testing was performed to support a determination of substantial equivalence to the predicate." It lists the types of bench tests conducted but does not provide specific acceptance criteria values or detailed reported performance results against those criteria.

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

Not applicable, as this refers to bench testing on physical components, not a clinical test set with patient data.

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

Not applicable. Ground truth for clinical data is irrelevant to bench testing of a hardware device.

4. Adjudication method for the test set:

Not applicable.

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. This device is not AI-powered, so no such study was conducted or is relevant.

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

No. This device is not an algorithm. Bench testing evaluates the physical device's performance.

7. The type of ground truth used:

Not applicable in the context of AI/ML. For the bench testing, the "ground truth" would be engineering specifications and validated test methods to assess the physical device's capabilities (e.g., ability to capture thrombus in a model, compatibility with stents).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The Expanse ICE Aspiration System is indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.

The Expanse ICE Aspiration System is a peripheral thrombectomy system consisting of several components:

• ICE Aspiration Catheter -
• ICE Aspiration Sheath -
• -Vacuum Fitting
• -High Flow Stopcock Connector
• -Y-Connector with Hemostatic Valve
• Hand Actuator Clip -

The ICE Aspiration System is designed for the minimally invasive removal of thrombus from the peripheral vasculature using aspiration. It is a single use, over-the-wire, catheterbased system with the ability to infuse fluid. The ICE Aspiration System consists of one aspiration catheter, one aspiration sheath, one vacuum fitting, one high flow stopcock connector, one Y-connector with hemostatic valve, and a hand actuator clip.

The ICE Aspiration System is introduced to the primary occlusion. The Aspiration Catheter is advanced through the Aspiration Sheath and targets aspiration directly to the thrombus. The Aspiration Catheter is then retracted back into the Aspiration Sheath. This process of extension and retraction of the Aspiration Catheter is then repeated to fully aspirate the clot. Suction is applied directly to the Aspiration Catheter from an external vacuum source to aspirate thrombus from an occluded vessel (maximum pressure -27.6 in Hg and minimum pressure of -8.0 in Hg).

Sterile saline flows through the Aspiration Sheath and into the Aspiration Catheter when connected proximally. No saline is injected into the patient during aspiration. The Aspiration Catheter and Sheath are visible under fluoroscopy. The hand actuator is an optional, proximal clip attached to the Aspiration Catheter to assist the user.

This document is a 510(k) premarket notification for the ICE Aspiration System, a medical device. It's a regulatory submission to the FDA, not a study report demonstrating acceptance criteria with a specific test set, ground truth, or MRMC study for AI assistance.

The document primarily focuses on establishing "substantial equivalence" of the ICE Aspiration System to existing predicate devices (Indigo Aspiration System and JETi 88 Peripheral Thrombectomy System) for regulatory clearance. It does not contain information about a study proving specific performance metrics against an AI-driven acceptance criteria for a diagnostic or AI-assisted device.

Therefore, I cannot provide the requested information from this document because it does not contain the details of an AI-related performance study. The "Performance Data" section (Section 5) refers to "Bench and animal testing" and lists various non-clinical tests (e.g., biocompatibility, fatigue, kink resistance), which are standard for most medical device clearances, but not the type of AI-specific performance study you are asking about.

The document does not describe:

• A table of acceptance criteria and reported device performance in the context of an AI study.
• Sample size, data provenance, or details about test sets for AI evaluation.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for AI.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• Standalone AI performance.
• Type of ground truth for AI.
• Training set sample size or how ground truth for training was established for an AI system.

Ask a specific question about this device