(90 days)
Alpha Omega NeuroTrek system is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons to aid in the placement of depth electrode.
The NeuroTrek is a physiological navigation system designed for clinical use during Pallidotomy or Thalamotomy and other neurosurgical procedures to assist in optimal target localization.
During surgery, a microelectrode is advanced into the brain with on-line recording and stimulation performed for precise focusing on the target organ and for evaluating the symptoms before and after. The physiological navigation and localization during the procedure is done for achieving better clinical results (short and long term). "On line" assessment of the electrophysiological activity assures the doctors that they are not about to cause irreversible damage to adjacent centers (i.e. Vision, Somatosensory), and allows confirmation of the target structure position.
The NeuroTrek system also enables design boundaries of target and localization of part position of the target for lesioning and electrode implantation.
The provided document is a 510(k) summary for the NeuroTrek Physiological Navigation System for Neurosurgery. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The document primarily focuses on:
- Device identification: Trade name, classification, submitter details.
- Predicate devices: List of substantially equivalent devices.
- Performance standards: A statement that no specific performance standards exist for such devices under the Act, but voluntary standards (IEC 601-1, IEC 601-1-2, IEC 601-1-4) are met.
- Indications for Use: What the device is intended for.
- Device Description: How the device works in general terms.
- FDA Clearance Letter: Confirmation of 510(k) clearance and substantial equivalence.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).