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The NUVISION™ Ultrasound Catheter is indicated for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The NUVISION™ NA V Utrasound Catheter and related accessory devices are indicated for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with the compatible CARTO™ 3 EP Navigation System, the catheter provides location information. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The NUVISION™ Catheters are sterile, single use ultrasound catheters. They intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of patients. The catheters are intended for imaging guidance only, not treatment or therapy delivery, during cardiac interventional percutaneous procedures.

The NUVISION Ultrasound Catheter and NUVISION NAV Ultrasound Catheter are sterile, single-use, disposable intracardiac echo (ICE) ultrasound imaging catheters. The distal end of the catheter has an ultrasound transducer with 2D acoustic element array on ASIC enabling real time 2D, 3D, and multiplane imaging. NUVISION Ultrasound Catheter is compatible with GE Vivid™ S70N and GE E95 Ultrasound System to enable 4D intra-cardiac imaging. While the NUVISION NAV Ultrasound Catheter's grid transducer combines the processing power of the GE Vivid™ S70N Ultrasound System to enable 4D intra-cardiac imaging and when coupled with a 3D location sensor enables location mapping in a compatible CARTO 3 System. The transducer array can be rotated independently of the deflection plane of the catheter shaft. The NUVISION NAV Ultrasound Catheter adds integration into the CARTO environment.

The provided text is a 510(k) Summary for the NUVISION™ Ultrasound Catheter and NUVISION™ NAV Ultrasound Catheter. This document is focused on demonstrating substantial equivalence to predicate devices, not on proving that the device meets specific performance criteria through a study with a test set, ground truth, experts, and statistical analysis as would be done for a software or AI/ML device.

Therefore, the requested information regarding acceptance criteria, device performance, sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for the training set cannot be found in this document.

This document states:

• "Both catheters met all acceptance criteria in accordance with appropriate test criteria and standards." (Page 7, section 1.6 Performance Testing)
• "The NUVISION Ultrasound Catheter and NUVISION NAV Ultrasound Catheter are substantially equivalent to its currently cleared predicate devices based on the successful completion of nonclinical bench testing, as well as the technological comparison exhibiting similar principles of design, operation, and indications for use." (Page 7, section 1.7 Conclusion on Safety and Effectiveness)

These statements indicate that some internal testing (bench testing) was performed to ensure the device met its design specifications and regulatory standards for substantial equivalence, but it does not detail the type of clinical or performance study that would be associated with the questions asked, especially for an AI/ML device. The device is an ultrasound catheter, not explicitly stated as an AI/ML device from this document.

Therefore, I cannot populate the table or provide the requested details based on the given text.

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