(89 days)
Intended Use: The Manual Disposable Micro-drive with Digital Display is intended to be used in conjunction with the Navigus™ family of Trajectory Guides for the precise positioning of microelectrodes, stimulating electrodes, implantable electrodes, or other instruments in the brain or nervous system.
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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for a medical device.
The provided text is a 510(k) clearance letter from the FDA for the "Navigus Manual Disposable Microdrive with Digital Display." This letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It outlines regulatory information, but does not contain details about performance studies or acceptance criteria met by the device.
§ 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).