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The Arrow UltraCath Continuous Nerve block Catheter is placed next to nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

Stimulating continuous nerve block catheters consist of a stainless steel spring coil encased in a polyurethane outer jacket. The inner spring coil contributes a kink-resistance nature to the catheter when bent through small radii, and in stimulating catheters provides electrical conductivity. A ribbon wire is welded to both the proximal and distal ends of the inside of the coil to prevent stretching. The coils of the main catheter body are tightly wound axially (small pitch), with zero space between adjacent coils. The catheter tip is visible under ultrasound.

The plastic jacket of the Conductive Resin Tip UltraCath Continuous Nerve Block Catheter is made of transparent resin and the catheter tip is made of black electrically conductive resin that covers the internal stainless steel spring coil and seals the system against undesired fluid or air ingress or egress. Anesthetics are distributed into the patient body through a single end hole located at the catheter distal end. The catheter distal tip is made of electrically conductive resin which provides an electrical contact point. The distal end of the catheter is printed with centimeter markings to aid in depth determination during catheter insertion. There is also printed distance indicator at proximal end in order to indicate proper catheter insertion inside the adaptor. A stylet placed inside the catheter's spring coil provides stiffness during the insertion procedure.

I am sorry, but the provided text does not contain information about the acceptance criteria and study proving a device meets them in the context of an AI/ML-based medical device. The document is a 510(k) summary for a physical medical device called the "UltraCath Continuous Nerve Block Catheter" and focuses on demonstrating substantial equivalence to a predicate device through various performance and biocompatibility tests.

There is no mention of:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes for test sets, data provenance, or use of experts and adjudication for ground truth related to an AI/ML algorithm.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone AI performance.
• Training set details for an AI/ML model.

The document lists various physical and chemical tests for the catheter, such as aspiration, column strength, flow rate, electrical leakage, and biocompatibility, but these are for the hardware itself, not an AI component.

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