(205 days)
The subject device, the Neuro Omega System incorporated the installed HaGuide software, including the Drive HeadStage unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes. The subject device, the Neuro Omega System incorporated the installed HaGuide software is also intended:
-To monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis of neuromuscular disease (EMG).
-To measure, record and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG).
-To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes.
-To provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder.
The device is intended for intraoperative use by medical personnel. Within hospitals, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.
The Neuro Omega system is designed for different neurosurgery and neurophysiologic clinical applications including recording from and stimulate brain motor and sensory neurons to accurate navigation of electrodes for neurosurgery target localization in treatment of movement disorders by and to aid in the placement of depth electrodes. The device is also designed for measuring bioelectric signals produced by muscles and stimulate peripheral nerves to aid in the diagnosis and prognosis of neuromuscular disease (EMG).
The device may also be used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head (EEG).
The subject device, the Neuro Omega System may also be used to measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes.
The subject device, the Neuro Omega System may also be used to provide stimulation via electrode pairs or a hand held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder.
The subject device, the Neuro Omega System incorporated the installed HaGuide software as a user option tool, which is a real-time software solution designed to accurately detects the Sub Thalamic Nucleus region, its entrance and exit boundaries as well gives the user a stimulation location recommendation.
The HaGuide software robustly detects intra STN detection of Dorso lateral Oscillatory Region (DLOR) and Ventro Medical Non-Oscillatory Region (VMNR) boundary. The tool presents real time graphs of power spectrum density and RMS of each region.
The Neuro Omega System, equipped with the HaGuide software, is designed to assist neurosurgeons in functional neurosurgery, specifically aiding in the placement of depth electrodes by accurately detecting the Sub Thalamic Nucleus (STN) region.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria & Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than explicitly listing quantitative acceptance criteria for the HaGuide software's performance, as would be typical for an AI/ML device approval under current guidelines. However, the one clear performance metric and its result are presented in the clinical performance test:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy of STN Entry/Exit Point Detection | Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements for STN entry point vs. exit point depth: 90.34% (95% CI, 85.27, 93.85%) |
| Correlation with Expert Measurements (STN Depth) | Correlation between HaGuide measurements and expert Neurosurgeon/Electrophysiologist measurements for STN entry site depth: 0.9492 (95% CL >0.91) |
| Correlation for STN exit site depth: 0.9317 (95% CL >0.91) | |
| Bland-Altman Analysis for Location Agreement | Bland-Altman analysis for the difference between HaGuide and expert measurements for STN entry site: 0.18 mm (95% CI, -0.9, 1.2 mm) |
| Bland-Altman analysis for STN exit site: -0.15 mm (95% CI, -1.25, 1 mm) | |
| Safety (No adverse events and complications observed) | "No adverse events and complications observed in the study." |
| Software Verification (Design output meets SW design input) | "All samples passed the acceptance criteria which determines the effectiveness of Neuro Omega System, the subject device, with HaGuide software." (This is a general statement about software quality, not specific performance metrics.) |
| System Verification (Design output meets system design input) | "All samples passed the acceptance criteria which determines the effectiveness of Neuro Omega System, the subject device, with HaGuide software." (Similar to software verification, a general statement about system quality.) |
| Sterilization Validation (`SAL of |
§ 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).