(148 days)
The GE Healthcare Navigation and Visualization System [InstaTrak® 3500 Plus System or FluoroTrak™ 9800 Plus System] together with the Axcess™ Bone Pin, is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotaxic surgery and which provides a reference to rigid structures such as sinus, skull, long bone or vertebra visible on medical images such as CT, MR or x-ray,
The Axcess™ Bone Pin is to be used where rigid fixation of a tracking device to bone is required.
The GE Healthcare Navigation and Visualization System [InstaTrak® 3500 Plus System or FluoroTrak™ 9800 Plus System] together with the Axcess™ Bone Pin. The Axcess™ Bone Pin is one example of the Axcess™ Bone Pin.
The provided text is a 510(k) premarket notification for a medical device (GE Healthcare InstaTrak® 3500 Plus/FluoroTrak™ 9800 Plus System with Axcess™ Bone Pin). This document focuses on demonstrating substantial equivalence to predicate devices and describes the intended use and classification of the device.
It does not contain information about acceptance criteria, device performance results from a study, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.
Therefore, I cannot provide the requested table or answer the specific questions about the study and its results based on the given input. The document is primarily a regulatory submission for market clearance, not a report of a performance study.
§ 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).