(296 days)
Alpha Omega Alpha Drive system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to aid in the placement of depth electrode.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Alpha Drive System. It grants market clearance based on substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested table and study details.
The document focuses solely on the regulatory approval process and states that the device is cleared for marketing based on substantial equivalence. It does not include the technical performance data or the details of any studies that would typically define acceptance criteria and prove a device meets them.
§ 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).