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The Evalve Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

The Steerable Guide Catheter consists of a Steerable Guide (Guide) and a Dilator provided EO sterile and for single-use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, a Dilator with a single central lumen and an atraumatic distal tip. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of .204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter and Dilator are packaged in two sealed Tyvek pouches, and boxed in a shelf-cardboard carton.

I am sorry, but the provided text does not contain the information required to populate the acceptance criteria table or describe a study that proves the device meets specific acceptance criteria in the context of AI/ML performance.

The document is a 510(k) summary for a Steerable Guide Catheter, a physical medical device, not a software or AI/ML device. Therefore, it does not discuss:

• Acceptance criteria in terms of AI/ML performance metrics (like sensitivity, specificity, AUC).
• Any studies involving test sets, training sets, data provenance, ground truth establishment by experts, adjudication methods, or MRMC studies for AI/ML performance.

The "in vitro tests" mentioned in the document (overall dimensions, bend test, guide-to-dilator transition test, Echogenicity, and Radiopacity) are related to the physical characteristics and functionality of the catheter itself, not to the performance of any AI/ML algorithm.

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