(90 days)
The NeXdrive Disposable Micro-drive for use the with FHC microTargeting® Drive System Display and Power Assist Accessories 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, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the "NeXdrive Disposable Microdrive" and primarily addresses its substantial equivalence to a predicate device and its indications for use.
The letter does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
- Information about training sets.
Therefore, I cannot fulfill your request for this specific information from the provided text.
§ 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).