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The Alviguide™ Blue+ Interventional Cardiology Guiding Catheter is intended for use in the intravascular introduction of interventional/diagnostic devices into the coronary vascular system.

The Alguide™ Endovascular Guiding Catheter is intended for use in the intravascular introduction of interventional/ diagnostic devices into the peripheral vascular system.

The Alviguide™ Blue+ and Alguide™ Guide Catheters are sterile, non-pyrogenic, single lumen catheters with a tri-layer catheter body construction consisting of a polymer inner layer and a radiopaque outer layer surrounding a stainless steel wire braid, and a soft tip at the distal end. The catheters are for single-use only.

The Alviguide™ Blue+ and Alguide™ Guide Catheters are provided in a variety of distal shape configurations and are available in Fr Sizes 5, 6, 7 and 8 and lengths of 45, 60, 65 and 80cm (Alguide™), and 100cm (Alviguide™ Blue+ and Alguide™).

The provided text describes the 510(k) premarket notification for two guiding catheters and lists the testing performed to demonstrate substantial equivalence to predicate devices. However, it does not contain information about the acceptance criteria for a device's performance in a study, nor does it detail a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.

The document focuses on:

• Device Description: Alviguide™ Blue+ Interventional Cardiology Guiding Catheter and Alguide™ Endovascular Guiding Catheter.
• Intended Use: Intravascular introduction of interventional/diagnostic devices into the coronary/peripheral vascular system.
• Substantial Equivalence: Comparison to predicate devices based on similar indications for use, design, materials, and nonclinical (bench) and biocompatibility testing.

The "testing in support of substantial equivalence determination" section lists various bench tests and biocompatibility tests, but these are focused on the physical and biological properties of the catheter itself, not on the performance of a diagnostic algorithm or AI system. There is no mention of "acceptance criteria" for a study in the sense of accuracy, sensitivity, specificity, or performance thresholds for an AI.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about an AI-driven study from the provided text. The document pertains to a physical medical device (catheter), not an AI/software-as-a-medical-device (SaMD).

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