(73 days)
The Navigation Panel Unit System (NPU) is an intraoperative image guided localization system that links a freehand probe tracked by a passive marker sensor system to a virtual computer image space on a patient's preoperative diagnostic image data set. The system is intended to be used as a positioning aid for navigation in ENT surgery, including but not limited to endoscopic surgery. The NPU is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the radiological imaging-based model . of the anatomy. Surgery procedures include but are not limited to the following: transphenoidal procedures, maxillary antrostomies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, frontal sinusotomies, intranasal procedures, intranasal tumor resections, otologic surgery, and ENT skull base surgery.
The Karl Storz Navigation Panel Unit (NPU) System is a multi-component system to be used as a positioning aid for navigation in ENT surgery. The software comprises a planning and treatment program in which an instrument is navigated on the basis of pre-loaded radiological image data.
The provided text is a 510(k) summary and FDA clearance letter for the Karl Storz Navigation Panel Unit (NPU) System. It describes the device, its intended use, and its classification, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information. The text focuses on the regulatory aspects of the device, rather than detailed performance evaluations.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).