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The Navigant™ Workstation with Niobe® Magnetic Navigation System is intended to navigate a compatible magnetic device through tissue to designated target sites in the right and left heart and coronary vasculature by orienting the device tip in a desired direction. The Navigant™ feature provides an enhanced navigation interface for the physician to control the MNS.

The Navigant™ Workstation with Niobe® Magnetic Navigation System [NWS05] is an interventional workstation for the navigation of appropriately equipped, magnetically adapted, devices (e.g., catheters or guidewires) through tissue to designated target sites. The system uses computer-controlled permanent magnets for orienting the tip of a magnetic device. The system employs magnetic fields to orient or steer the tip of a magnetic device. The NWS05 is a modification to the Navigant™ Workstation/Niobe® Magnetic Navigation System (K032937). The changes introduce new software design and mode of operation, new hardware, and a new range of motion to improve imaging, but maintain the existing technology for orientation of magnetically-adapted devices and clinical utility. The NWS05 requires a digital fluoroscopy system to function properly.

The provided text does not contain specific acceptance criteria or a study outlining the device's performance against such criteria. Instead, it is a 510(k) summary for the Stereotaxis, Inc. Navigant™/Niobe® Magnetic Navigation System (NWS05), focusing on establishing substantial equivalence to a predicate device (NWS2; K032937).

The document states that "Performance testing has demonstrated substantial equivalence of the new device to the predicate device." However, it does not provide details on what this performance testing entailed, what specific metrics were measured, or what acceptance criteria were used to determine substantial equivalence. It explicitly states that "Animal and clinical data are not necessary to support the modifications" for the NWS05 and refers back to K032937 for "Application data (animal and clinical) for magnetic navigation."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based solely on the provided text. The document indicates a reliance on the predicate device's prior approval and the inherent safety and effectiveness of the existing technology as justification for substantial equivalence for the modified device.

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