(70 days)
For use as a stereotactic system accessory to aid in auto-registration and localization of rigid patient anatomical structure in either open or percutaneous image guided surgery. It is indicated for any medical condition in which the use of stereotactic surgery may be considered to be appropriate, and where a reference to a rigid anatomical structure can be identified relative to a CT or MRbased model of the anatomy.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Northern Digital Incorporated regarding their NDI Passive Spheres™ device. It primarily discusses the regulatory classification of the device and its indications for use.
Crucially, this document does not contain any information regarding acceptance criteria, reported device performance, study designs, sample sizes, ground truth establishment, or expert qualifications for a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information based on the given text. The document confirms that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use, but it does not detail the testing or studies conducted to demonstrate this equivalence or establish performance metrics.
§ 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).