(178 days)
The FlowTriever2 Catheter is indicated for:
- · The non-surgical removal of emboli and thrombi from peripheral blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The FlowTriever2 Catheter is intended for use in the peripheral vasculature.
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. The system is comprised of two main components packaged separately:
• Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr)
• FlowTriever2 Catheter
The FlowTriever2 Catheter is inserted through the Triever Catheter and advanced to the thrombus. Self-expanding disk(s) are deployed to engage thrombus by retracting the outer delivery catheter. The FlowTriever2 Catheter is retracted into the Triever Catheter to capture the targeted thrombus. Additional clot may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter and FlowTriever2 Catheter are removed from the patient.
The provided text does not describe a study involving an AI/Machine Learning device or any associated acceptance criteria for such a device. The document is an FDA 510(k) clearance letter for the FlowTriever Retrieval/Aspiration System, a medical device used for the non-surgical removal of emboli and thrombi from peripheral blood vessels.
The acceptance criteria and study described in the document relate to the mechanical and functional performance of the medical device itself, not to the performance of an AI algorithm.
Therefore, I cannot provide the requested information regarding AI device acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies. The document only mentions "Non-Clinical Testing" and "Animal testing" that met predetermined acceptance criteria for the physical device.
Here's what can be extracted from the document regarding the device's acceptance:
The "Non-Clinical Testing" section describes the verification and validation tests performed to support the substantial equivalence of the modified FlowTriever Retrieval/Aspiration System. These tests demonstrated compliance with relevant product specifications and met predetermined acceptance criteria.
A table of the acceptance criteria (tests performed) and the reported device performance (met criteria) is as follows:
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Visual & Dimensional Inspection | Met predetermined acceptance criteria (implied by "all acceptance criteria were met") |
| Guidewire Compatibility Verification | Met predetermined acceptance criteria |
| Radial Expansion Force | Met predetermined acceptance criteria |
| Deployment Force | Met predetermined acceptance criteria |
| Retraction Force | Met predetermined acceptance criteria |
| Element Visual Inspection; Post Retraction Cycles | Met predetermined acceptance criteria |
| Leak and Vacuum Test; Post Retraction Cycles | Met predetermined acceptance criteria |
| Kink Resistance | Met predetermined acceptance criteria |
| Clot Analog Burden Removal Validation | Met predetermined acceptance criteria |
| Chronic Clot Analog Burden Removal Validation | Met predetermined acceptance criteria |
| Simulated Use, Track and Tensile | Met predetermined acceptance criteria |
| Liquid Leakage under Pressure | Met predetermined acceptance criteria |
| Burst Pressure | Met predetermined acceptance criteria |
| Simulated Use, Torque | Met predetermined acceptance criteria |
| Corrosion Resistance | Met predetermined acceptance criteria |
| Particulate testing | Met predetermined acceptance criteria |
Regarding the other requested information for an AI study:
- Sample sized used for the test set and the data provenance: Not applicable. The document discusses in vitro and animal testing for a physical device, not an AI test set.
- Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for a physical device's mechanical performance is established through engineering specifications and quantifiable measurements, not expert consensus on image interpretation.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not for an AI device. The document states "Clinical testing was not required for the determination of substantial equivalence" for this physical device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For this physical device, the ground truth is based on engineering specifications, physical measurements, and performance benchmarks in controlled environments (e.g., in vitro and animal models).
- The sample size for the training set: Not applicable for this type of device submission.
- How the ground truth for the training set was established: Not applicable.
§ 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).