(30 days)
The Cerenovus Large Bore Catheter, with the Cerenovus Aspiration Tubing Set and a compatible aspiration pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
The Cerenovus Aspiration Tubing Set is intended to connect the Cerenovus Large Bore Catheter or the CEREGLIDE™ 71 Intermediate Catheter to the canister of a compatible aspiration pump and to allow the user to control the fluid flow.
The Cerenovus Large Bore Catheter is a variable stiffness, single lumen catheter designed to be introduced over a steerable guide wire or microcatheter into the neuro vasculature. The catheter shaft is composed of a stainless steel variable pitch braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with polymer materials, which encapsulate the stainless steel braid construction. The catheter has a stiff proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The distal end of the catheter has a radiopaque marker band to facilitate fluoroscopic visualization and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a luer fitting located on the end of the catheter hub which can be used to attach accessories for flushing and aspiration. An ID band is placed at the distal end of the hub over a strain relief. The catheter is packaged with a hemostasis valve with a side port and two peel-away introducers as accessories. The hemostasis valve with side port is used for flushing, insertion of catheters, and connection to an external aspiration system. The peel away introducer sheaths are designed to protect the distal tip of the catheter during insertion into the hemostasis valve.
The Cerenovus Large Bore Catheter can be connected to a compatible aspiration pump using the Cerenovus Aspiration Tubing Set.
The provided text does not describe an acceptance criteria study for an AI/ML-enabled device but rather a 510(k) submission for a physical medical device (Cerenovus Large Bore Catheter and Aspiration Tubing Set). Therefore, much of the requested information regarding AI/ML device performance (like expert consensus, adjudication methods, MRMC studies, training/test set details) is not applicable or present in the document.
However, I can extract the relevant acceptance criteria and performance data for the mechanical device as found in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (implicit from "PASS" result) | Reported Device Performance |
|---|---|---|
| Static Flow Rate | Samples meet the established acceptance criteria | PASS |
| Aspiration Flow Rate | Samples meet the established acceptance criteria | PASS |
Explanation of "Acceptance Criteria" for this context:
For physical medical devices, "acceptance criteria" for performance testing typically refer to specific measurable thresholds or ranges that the device must demonstrate to confirm its functionality and safety. While the exact numerical values for these criteria are not explicitly stated in this summary, the document indicates that pre-established criteria exist and were met ("Samples met the established acceptance criteria").
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated in the summary. The document mentions "samples" in the plural form were tested for each performance test.
- Data provenance: Not explicitly stated. The testing ("Performance Testing - Bench") was conducted by Cerenovus, Inc. as part of their 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This pertains to AI/ML device evaluations. For a mechanical device, performance is typically measured against engineering specifications and industry standards, not expert-established ground truth in the same manner as image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This pertains to AI/ML device evaluations.
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 pertains to AI/ML device evaluations. The device mentioned is a physical catheter and aspiration set, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This pertains to AI/ML device evaluations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Testing / Engineering Specifications: For this mechanical device, the "ground truth" or reference for performance is established by engineering specifications, validated test methods, and potentially industry standards (e.g., ISO, ASTM for material properties, fluid dynamics). The specific parameters measured (flow rate) are compared against pre-defined acceptable ranges.
8. The sample size for the training set:
- Not applicable. This pertains to AI/ML device evaluations. This device is not an AI/ML model that requires training data.
9. How the ground truth for the training set was established:
- Not applicable. This pertains to AI/ML device evaluations.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).