(23 days)
The Artix 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 Thrombectomy Device is intended for use in the peripheral vasculature.
The Artix Thrombectomy Device (“Artix”) is a single-use over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature.
Artix is inserted through an 8 Fr sheath over a pre-placed 0.014" guidewire and advanced to the thrombus. A self-expanding nitinol element is deployed to engage thrombus by retracting the outer delivery catheter. Artix is then retracted into the sheath to capture the targeted thrombus. Additional clot may be removed by aspiration with a Luer syringe (not provided). After the procedure is complete, the Artix and sheath are removed from the patient.
The provided document is a 510(k) summary for the Artix Thrombectomy Device. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain details about specific acceptance criteria, study methodologies, sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth types, or training set information for an AI/CADe device.
The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." Instead, it relies on non-clinical testing to demonstrate substantial equivalence to the predicate device.
Therefore, most of the requested information regarding acceptance criteria and studies for an AI/CADe device cannot be extracted from this document because it describes a medical device (thrombectomy catheter), not an AI/CADe system.
Here's what can be extracted based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the devices conform to established product specifications."
However, it does not explicitly list the specific acceptance criteria or the quantitative reported performance of the device against those criteria. It only confirms that some acceptance criteria (identified through Design Failure Modes and Effects Analysis) were met by non-clinical testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly specified in the document) | "All acceptance criteria were met" |
2. Sample size used for the test set and the data provenance
N/A. The document describes non-clinical bench testing for a physical medical device, not a diagnostic AI/CADe system. Therefore, there is no "test set" in the context of image data or clinical data for an AI algorithm. The document mentions "verification and validation testing" but does not specify sample sizes or data provenance for these non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. As this is not an AI/CADe system, there's no "ground truth" for a test set established by experts in the context of diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Not applicable for a physical medical device clearance based on non-clinical testing.
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." Therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. No clinical "ground truth" was used for this device clearance, as it relied on non-clinical bench testing to demonstrate substantial equivalence.
8. The sample size for the training set
N/A. This is a physical medical device, not an AI/CADe system, so there is no training set.
9. How the ground truth for the training set was established
N/A. Not applicable.
In summary, the provided FDA 510(k) document is for a physical medical device (thrombectomy catheter) and does not contain the information typically required for an AI/CADe device, as it did not involve clinical trials, expert reviews of diagnostic images, or AI algorithm performance evaluation.
§ 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).