(297 days)
Frameless stereotactic cranial neurosurgery and intraoperative would be surgical guidance.
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The provided text is a 510(k) clearance letter from the FDA to BrainLAB USA, Inc. for their "VectorVision" device. This document primarily focuses on regulatory approval and does not contain the detailed performance study information, acceptance criteria, or sample sizes you've requested.
Therefore, I cannot provide the information you asked for based on the input text. The document confirms that the device is substantially equivalent to a predicate device and can be marketed, but does not include the specifics of the underlying validation studies.
§ 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).