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The Spinnaker is indicated for use in facilitating access through distal, tortuous vasculature, and may be used for the controlled, regional infusion of diagnostic agents, such as contrast media and Target Therapeutics' Berenstein Liquid Coil -10 in the peripheral and neuro vasculature. It is not intended for use in the coronary vasculature.

Spinnaker Infusion Catheter is a single lumen device with a graded shaft stiffness, ranging from a highly flexible tip to a semi-rigid proximal section that allows ease of advancement by the physician. A lure fitting located on the catherer hub is used for the attachment of accessories. Spinnaker is manufactured with HYDROLENE®, a hydrophilic surface coating that reduces friction during manipulation in the vessel.

The Spinnaker Infusion Catheter will be made available as a system consisting of a Spinnaker Infusion Catheter, a stylet with a torque device attached, and a steam shaping mandrel.

SPINNAKER with HYDROLENE Infusion Catheter (SPINNAKER) is a single lumen device designed to aid the physician in accessing distal vasculature when used with a guiding catheter. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section allows ease of advancement by the physician. A luer fitting located on the catheter hub is used for the attachment of accessories. A radiopaque tip and body facilitate fluoroscopic visualization. SPINNAKER is manufactured with HYDROLENE, a hydrophilic surface that reduces friction during manipulation in the vessel. The stylet accompanying the SPINNAKER is used to increase rigidity of the distal section during introduction into the guiding catheter. The steam shaping mandrel packaged with the SPINNAKER is used when the physician desires to shape the catheter's distal end.

The provided text describes a medical device, the SPINNAKER™ Infusion Catheter, and its substantial equivalence to predicate devices based on performance and biocompatibility testing. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/ML device evaluations (e.g., sensitivity, specificity, accuracy, or comparative effectiveness with human readers).

The document focuses on:

• Device Description: Physical characteristics, materials, and components.
• Intended Use: Facilitating access through vasculature and infusion of diagnostic agents.
• Predicate Devices: Balt Magic Infusion Catheter, Zephyr Infusion Catheter.
• Testing for Substantial Equivalence: Flow rates, tip flexibility, tensile, static rupture, coefficient of friction, and biocompatibility.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone study details because this information is not present in the provided text.

The 'testing in support of substantial equivalence' mentioned refers to engineering and bench testing relevant to the physical and functional aspects of a catheter, not clinical performance metrics typically associated with AI/ML diagnostic devices.

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