(85 days)
The Flow Triever Retrieval/Aspiration System consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. 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 Flow Triever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of pulmonary embolism. The system is comprised of three main components packaged separately:
● Aspiration Guide Catheter
● FlowTriever Catheter (available in 3 sizes: 6-10 mm, 11-14 mm, and 15-18 mm)
● Retraction Aspirator
The FlowTriever Catheter is inserted through the Aspiration Guide Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The hand-lever operated Retraction Aspirator simultaneously aspirates fluids and retracts the FlowTriever Catheter with thrombus into the Aspiration Guide Catheter to capture clot and restore blood flow.
The provided text describes a 510(k) premarket notification for the FlowTriever Retrieval/Aspiration System. The information focuses on demonstrating substantial equivalence to a predicate device, rather than a standalone study proving the device meets specific acceptance criteria in the context of an AI/ML device.
However, based on the information provided, I can extract details about the clinical study conducted for the FlowTriever Retrieval/Aspiration System and present them as if they were acceptance criteria and performance data for a device, even though it's a medical device, not an AI/ML system.
Here's an attempt to structure the information as requested, interpreting the clinical study's endpoints as "acceptance criteria" for the device and its performance against those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Performance Goal) | Reported Device Performance (Achieved) |
|---|---|---|
| Primary Safety Endpoint | Composite of major adverse events (MAE) at 48 hours, defined as:Device-related deathMajor bleedingTreatment-related adverse events (clinical deterioration, pulmonary vascular injury, or cardiac injury) | The study met the performance goals for this primary safety endpoint. (Specific numerical data not provided in the document). |
| Primary Effectiveness Endpoint | Reduction in RV/LV ratio from baseline to 48 hours. | The study met the performance goals for this primary effectiveness endpoint. (Specific numerical data not provided in the document). |
Note: The document states the study "met the performance goals" but does not provide the specific numerical threshold for these goals or the exact numerical results obtained.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Study (Test Set): 106 subjects
- Data Provenance: Prospective, single-arm, multicenter study. The country of origin of the data is not explicitly stated, but given the FDA submission, it is likely that the study was primarily conducted in the United States or included US sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study evaluates the safety and effectiveness of a physical medical device (FlowTriever System) for treating acute pulmonary embolism (PE) by measuring clinical endpoints (MAE, RV/LV ratio), rather than assessing an AI's performance against expert-annotated ground truth. Therefore, the concept of "experts establishing ground truth for the test set" in the context of an AI/ML device is not directly applicable to this information.
4. Adjudication Method for the Test Set
This information is not explicitly provided in the document. For clinical trials like this, adverse events and endpoint evaluations are typically adjudicated by clinical events committees (CECs) or independent core laboratories, but the specific method (e.g., 2+1, 3+1) is not detailed.
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, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This submission is for a physical medical device (catheter system) for treating pulmonary embolism, not an AI/ML diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm-only performance study was not done. This is a physical medical device, not an algorithm. The clinical study evaluated the device's performance in actual patients.
7. The Type of Ground Truth Used
The "ground truth" for the clinical study described was based on clinical outcomes data from patients, including:
- Incidence of major adverse events (MAE), such as device-related death, major bleeding, and specific treatment-related adverse events.
- Measured physiological changes, specifically reduction in RV/LV ratio.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This is a physical medical device. The concept of a "training set" typically applies to AI/ML models that learn from data. The device itself does not have a training set in this context. The clinical study mentioned (FLARE Study) served as the primary clinical validation (test set) for the device's safety and effectiveness.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as #8.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).