(157 days)
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator.
The Shockwave Mr+ Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure.
The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized. lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator. IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.
The provided document, a 510(k) summary for the Shockwave Intravascular Lithotripsy (IVL) System, outlines the device's technical specifications and how it demonstrates substantial equivalence to a predicate device. However, it does not include information about a study that utilized acceptance criteria based on accuracy metrics for an AI/ML device, nor does it detail typical components of such studies (like sample sizes for test/training sets, expert adjudication, or MRMC studies).
The document is primarily a notification to the FDA about modifications to an existing medical device and its continued substantial equivalence, rather than a clinical trial report or a performance study for an AI/ML diagnostic.
Therefore, I cannot extract the requested information because the provided text describes a medical device (intravascular lithotripsy system) approval process based on substantial equivalence to a predicate device, which focuses on device design and performance verification testing, not an AI/ML model's diagnostic accuracy or a related clinical study involving human readers and ground truth establishment.
The sections you requested, such as acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity), sample sizes for test/training sets, ground truth establishment by experts, and MRMC studies, are typical for evaluations of AI/ML diagnostic devices. This document describes a physical medical device (catheter-based system) and its mechanical/electrical performance, not an AI/ML system's diagnostic performance.
§ 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).