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The JETSTREAM System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature.

The Jetstream Systems are rotational atherectomy catheter systems designed with either a fixed (Jetstream SC 1.85, Jetstream SC 1.6) or an expandable (Jetstream XC 2.4/3.4, Jetstream XC 2.1/3.0) cutting tip intended for use in debulking and treating vascular disease in the peripheral vasculature. Separate lumens within the Catheter allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through a port in the Catheter tip to an external collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.

The Jetstream Systems consist of two primary components: a Catheter with Control Pod and a Console, which are packaged separately. Each of these system components is described generally as follows:

• Jetstream Catheter with Control Pod: A sterile, single-use unit consisting of an electrically-driven Catheter with attached Control Pod. As with the predicate device, the modified Jetstream Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities and the Control Pod with Activation Handle provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a single pouched tray.
• . PV Console: A reusable compact PV Console, with two (2) peristaltic pumps for aspiration and infusion, power supply, system controller, kevpad interface, and LED indicators for device operational status. The PV Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.

The primary modification of this 510(k) is a redesign of the Control Pod and Activation Handle, which improves the user interface. This modification applies to the entire family of Jetstream Systems.

I'm sorry, but your request cannot be fulfilled. The provided text, which is an FDA 510(k) summary for a medical device called the "Jetstream Systems," describes a physical medical device designed for atherectomy (removing plaque from arteries).

The questions you've asked, such as "A table of acceptance criteria and the reported device performance," "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," and inquiries about "MRMC comparative effectiveness study," "standalone (algorithm only) performance," and "ground truth for the training set," are typical questions asked about AI/ML-based medical devices or diagnostic software, which rely on digital data and algorithmic performance.

Since the document describes a physical atherectomy catheter system, and not an AI/ML diagnostic or image analysis device, the information required to answer your questions is not present in the provided text. The testing summarized (e.g., Dimensional Verification, Heat Generation, System Reliability, Aspiration Efficiency, Electrical Safety, Biocompatibility) pertains to the physical and functional aspects of a mechanical device, not the performance of an algorithm against a ground truth dataset.

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