(19 days)
The Vascutrak™ PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, illio-femoral, popliteal, infra-popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arterioveneous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents, self-expanding stents, and stent grafts in the peripheral vasculature.
The Vascutrak™ PTA Dilatation Catheter is composed of a flexible shaft with a semicompliant balloon fixed at the distal end and a 0.018" or 0.014" guidewire lumen through the distal tip. The catheter shaft contains an inflation lumen that begins at the proximal female luer lock hub and ends in the proximal portion of the balloon. The proximal portion of the shaft is comprised of a stainless steel tube while the distal portion of the shaft contains a stainless steel core wire that parallels the inflation lumen, exits the shaft proximal to the balloon and terminates distal to the balloon. The distal portion of the catheter shaft has a hydrophilic coating for lubricity. Two radiopaque marker bands localed on the outer core wire delineate the working length of the balloon to aid in balloon placement. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use.
The provided text describes a medical device, the Vascutrak™ PTA Dilatation Catheter, and its substantial equivalence to predicate devices, but does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of AI/ML performance.
Instead, the document is a 510(k) premarket notification summary to the FDA, demonstrating the device's substantial equivalence to previously cleared devices based on in vitro performance testing relevant to physical device characteristics, not AI/ML performance metrics.
Therefore, I cannot provide the requested information from the given text.
To answer your request, the document would need to include:
- Specific performance metrics (e.g., accuracy, sensitivity, specificity, AUC) for an AI/ML device.
- Thresholds or targets for these metrics to be considered "accepted."
- Details of a clinical or retrospective study specifically evaluating the AI/ML component's performance against a ground truth.
- Information on human expert involvement in ground truth establishment and potential human-in-the-loop studies.
- Details on training and test data sets for an AI/ML model.
§ 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).