Search Results

Ask a specific question about this device

Alpha Omega NeuroDrive 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.

NeuroDrive system

This document is a 510(k) premarket notification from the FDA regarding the Alpha Omega NeuroDrive system. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This type of FDA letter confirms substantial equivalence to a predicate device, which allows the company to market it. It does not typically include detailed study results, sample sizes, or ground truth methodologies that would be found in a clinical trial report or a scientific publication.

Therefore, I cannot provide the requested information from this document.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device