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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:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size:
  • Patients enrolled: 81
  • Surgeries evaluated: 105
  • Electrodes evaluated: 213 (This indicates multiple electrodes were evaluated per surgery/patient)
• Data Provenance: Retrospective, Multi-centre study.
  • Country of Origin: Both in United States and Outside United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Number of Experts: Not explicitly stated as a specific number. The document refers to "expert Neurosurgeon/Electrophysiologist" (singular and plural) consistently. It's implied there were qualified experts, but not how many participated in the ground truth labeling for the test set.
• Qualifications of Experts: "qualified user (Neurosurgeon/Electrophysiologist) concluding about the location of the entry and exit points of the sub-thalamic nucleus (STN) from the visual and audio recording patterns." No specific years of experience or board certification are mentioned, but their professional roles imply expertise in functional neurosurgery and electrophysiology.

4. Adjudication Method for the Test Set:

• The document states that the "reference against which the accuracy of HaGuide mapping was compared is the gold standard being the qualified user (Neurosurgeon/Electrophysiologist) concluding about the location of the entry and exit points of the sub-thalamic nucleus (STN) from the visual and audio recording patterns." This implies that the expert's determination was considered the ground truth without further multi-expert adjudication described (e.g., 2+1 or 3+1). It is a single expert (or single group of experts acting as one unit) making the determination.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. without AI Assistance:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study of human readers with and without AI assistance was not reported. The study focused on the standalone performance of the HaGuide software compared to expert consensus.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Yes, the clinical study appears to evaluate the HaGuide software in a standalone capacity, comparing its automatic measurements ("HaGuide software measurements") directly to "expert Neurosurgeon/Electrophysiologist measurements." The software provides "in mapping sub-thalamic nucleus (STN) boundaries" and "gives the user a stimulation location recommendation," which implies an algorithmic output.

7. The Type of Ground Truth Used:

• The type of ground truth used was expert consensus/determination based on visual and audio recording patterns during Deep Brain Stimulation (DBS) procedures. The document explicitly states: "The reference against which the accuracy of HaGuide mapping was compared is the gold standard being the qualified user (Neurosurgeon/Electrophysiologist) concluding about the location of the entry and exit points of the sub-thalamic nucleus (STN) from the visual and audio recording patterns."

8. The Sample Size for the Training Set:

• The document does not provide information regarding the sample size used for the training set of the HaGuide software. It only describes the "clinical performance test" which is an evaluation on a test set (81 patients, 105 surgeries, 213 electrodes).

9. How the Ground Truth for the Training Set Was Established:

• The document does not provide information on how the ground truth for any potential training set was established. It only details the ground truth for the clinical validation (test) set.

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