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Neuro Omega System:

The Neuro Omega System with the incorporated 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 Neuro Omega System with the incorporated 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 and prognosis 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 a seizure disorder.

The Neuro Omega System with the incorporated installed HaGuide Software, is intended for intraoperative use by medical personnel. Within hospitals, laboratories, clinics, or nursing home settings or outside of a medical facility under the direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.

NeuroSmart System:

The NeuroSmart System with the incorporated HaGuide Software, is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to record from and stimulate brain motor and to aid in the placement of depth electrodes

The cleared devices under K220553, the HaGuide Software incorporated in Neuro Omega/NeuroSmart systems, is designed to detect the STN region, it detects the entrance and exit boundaries of STN regions. Furthermore, it presents real-time graphs of power spectrum density and the normalized root mean square (nRMS) of the region. The HaGuide Software consists of the following components:

• Patient Dashboard: The Patient Dashboard is comprised of a list of patients/cases that the user added, providing a user-friendly way to manage the surgery cases.
• Planning Setup: The Planning Setup is used by the user to setup the surgery planning.
• Trajectory Setup: The Trajectory Setup is used by the user to setup trajectory.
• MER/HaGuide: MER/HaGuide is comprised of:
  • Real-time Microelectrode Recording (MER) signal processing, presented as o Normalized Root Mean Square (NRMS) and Power Spectrum Density (PSD) graphs, to assist the user to interpret the signals.
  • MER notes taking adding notes and tags to specific site location to o document and annotate the signals.
  • HaGuide Recommendation: Detection of the Subthalamic Nucleus (STN) o borders, including the Intra STN detection of Dorsolateral Oscillatory Region (DLOR) and Ventromedial Non-Oscillatory Region (VMNR) boundary.
• Operation Room Report Upload – Cloud: The OR report uploading feature is used to export the case data and HaGuide graphs and HaGuide recommendation securely to the cloud.
• Raw Data Upload – Cloud: The raw data uploading feature is used to upload the raw recording data files securely to the cloud for offline processing

The HaGuide Software can work in three setups:

• 1. The HaGuide Software can be installed on the Neuro Omega/NeuroSmart PC and used on the system.
• 2. The HaGuide Software can be installed on an external PC as a standalone software for the purpose of working in off-line mode with no connection to the system.

In all setups the safety and effectiveness of the Neuro Omega/NeuroSmart systems isn't compromised, as the HaGuide Software is a non-blocking software (it doesn't affect the system's functionality even in malfunction). The HaGuide Software can run on both modes without affecting the Neuro Omega/NeuroSmart systems safety and effectiveness, nor its functionality.

The provided text describes the regulatory clearance for the Neuro Omega System and NeuroSmart System, which incorporate the HaGuide Software. It focuses heavily on the software as a standalone component and its integration with the existing systems.

Based on the provided text, the study proving the device meets acceptance criteria is primarily non-clinical performance testing of the HaGuide Software and its integration with the Neuro Omega/NeuroSmart systems, rather than a clinical study evaluating human-in-the-loop performance or diagnostic accuracy with ground truth from clinical data.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• HaGuide SW integration with Alpha Omega cloud is tested.
• The verification tests cover the design inputs (SRS) as well as use cases and sanity tests. | All tests passed the acceptance criteria. |
  | Penetration Testing | The identified risks are determined, then the scales are passed in accordance to NIST SP 800-30r1. | Overall cybersecurity risks related to Confidentiality, Integrity, and Availability have been evaluated. This includes risks related to software supply chain. Any risks introduced by risk controls were evaluated and mitigated to an acceptable level. |
  | EMC Reports (IEC 60601-1-2) | The subject devices are safe and effective and meet the requirements of IEC 60601-1-2:2014, IEC 60601-1-2:014/AMD1:2020. | All tests passed the acceptance criteria. |
  | Safety Reports (IEC 60601-1) | Neuro Omega/NeuroSmart systems incorporated the HaGuide Software are safe and effective and meet the requirements of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020. | All tests passed the acceptance criteria. |

Note: The provided document describes non-clinical performance tests focused on software verification, cybersecurity, electromagnetic compatibility (EMC), and electrical safety. It does not contain information about clinical performance such as diagnostic accuracy, sensitivity, or specificity in a medical context. The "HaGuide Recommendation" feature for STN border detection is mentioned, but no specific performance metrics or clinical study results for this feature are provided in the excerpt. The submission is framed as a 510(k) for a "new infrastructure and GUI" of the HaGuide software, maintaining the same purpose as the predicate, which implies a focus on demonstrating that the changes do not introduce new safety or effectiveness issues, rather than proving new clinical effectiveness.

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical data. The tests performed are engineering-focused:
  • Software/System Verification: This involves internal regression tests and testing against "use cases and sanity tests." The number of test cases or specific data points tested is not enumerated.
  • Penetration Testing: This involves analyzing and identifying risks, not a numerical "test set" of patient data.
  • EMC/Safety Reports: These are engineering compliance tests performed on the physical devices.
• Data Provenance: Not applicable in the context of clinical data for these non-clinical performance tests. The document does not describe the use of patient data for testing device performance related to medical diagnosis or treatment. The HaGuide Software's ability to "detect the STN region" and present "real-time graphs of power spectrum density and the normalized root mean square (nRMS)" suggests it processes physiological signals, but how these processed signals were specifically "tested" for accuracy against a clinical ground truth is not detailed in this section. The mention of "Raw Data Upload – Cloud" for "offline processing" suggests data collection, but not its use as a test set for a performance study.

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

Not applicable. The provided document describes non-clinical performance tests, not a clinical study involving human experts establishing ground truth for patient data.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not describe an MRMC study or any clinical comparative effectiveness study involving human readers with and without AI assistance. The focus is on the functional verification and safety of the software and system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The HaGuide Software is described as having a "standalone software" mode for "off-line processing" and for "visual purpose only, meaning receive data from the systems and present it in graphs." While it can run in standalone mode, the "performance" described in the acceptance criteria table is for functional verification, cybersecurity, and electrical safety, not for a standalone clinical performance evaluation of its algorithms (e.g., accuracy of STN detection). The document states, "No changes are made to the retrieved data. Furthermore, the data will be used for verification only for the neurologist prior to fine-tuning the IPG work mode by using the IPG interface (not Alpha Omega's device)." This suggests the software provides information to clinicians, but its algorithmic accuracy in providing medical insights is not the subject of the detailed performance tests presented.

7. The Type of Ground Truth Used

For the reported non-clinical performance tests:

• Software/System Verification: Ground truth is established by the defined "design inputs (SRS) as well as use cases and sanity tests." This is based on functional and technical specifications, not clinical outcomes or expert consensus.
• Penetration Testing: Ground truth is against cybersecurity best practices and standards (e.g., NIST SP 800-30r1).
• EMC/Safety Reports: Ground truth is against established international standards (IEC 60601-1-2 and IEC 60601-1).

No clinical ground truth (e.g., pathology, surgical findings, long-term outcomes, or expert consensus on clinical images/signals) is mentioned as being used for the performance evaluation described.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the use of machine learning or deep learning models that would require a "training set" for the HaGuide Software's core functionality. While the software "detects the STN region," it's not specified if this detection relies on a trained AI model or deterministic algorithms. The "new infrastructure and GUI" suggests software updates rather than new AI model development requiring a training set.

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

Not applicable, as no training set for an AI model is described.

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The Neuro Omega system with the incorporated Navigation Tool software (the improved 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 with the incorporated Navigation Tool 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 and prognosis 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 a seizure disorder.

The Neuro Omega with the incorporated installed Navigation tool software, is intended for intraoperative use by medical personnel. Within hospitals, laboratories, clinics, or nursing home settings or outside of a medical facility under the direct supervision of a medical professional. The device may also be placed in the intensive care unit or operating room for continuous recording.

The NeuroSmart System with the incorporated Navigation Tool software, is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes.

The Neuro Omega system is designed for different neurosurgery and neurophysiologic clinical applications including recording from and stimulating 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 stimulating peripheral nerves to aid in the diagnosis 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 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 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 the treatment of patients with a seizure disorder.

The subject device, the Neuro Omega incorporated the installed Navigation Tool software (the improved HaGuide software) is a real-time software incorporated in electrophysiological recording and stimulating systems (like: Neuro Omega and NeuroSmart systems).

The tool is designed to detect the STN region (improved HaGuide Tool as was cleared under K171581 for Neuro Omega & K172042 for NeuroSmart), it detects the entrance and exit boundaries of STN regions. The tool gives the user a stimulation location recommendation. Furthermore, the tool presents real-time graphs of power spectrum density and RMS of STN region.

The Navigation Tool can aid in the placement of a compatible DBS Lead when the lead is connected to the cleared Alpha Omega Disposable Sterile LeadConfirm (K191739) and to the Neuro Omega System. This feature allows the user to record through the implanted lead and based on the recordings show simple spectral measures (PSD) within the frequency bands of interest. Based on the recordings from the lead, and the NeuroProbe MicroElectrode recordings, this feature shows the correlation in frequency band between both these recordings.

When the subject device, the Neuro Omega incorporated the installed Navigation tool is connected to the internet, the relevant intraoperative data collected during DBS surgery can be uploaded to Alpha Omega's cloud by the physician for Neurologist use. This information will assist the Neurologist in programming of the Implantable Pulse Generator (IPG).

Alpha Omega's NeuroSmart system physiological navigation system is accurate, aiding the neurosurgeons during functional neurosurgery for placing Deep Brain Stimulation (DBS) electrodes.

The NeuroSmart system can record signals from the brain cells or stimulate the brain target zone during the operation procedure.

The subject device, the NeuroSmart incorporated the installed Navigation Tool software improved HaGuide software) is a real-time software incorporated in (the electrophysiological recording and stimulating systems (like: Neuro Omega and Neuro Smart systems).

The tool is designed to detect the STN, it detects the entrance and exit boundaries of STN regions. The tool gives the user a stimulation location recommendation. Furthermore, the tool presents real-time graphs of power spectrum density and RMS of each region.

The Navigation Tool can aid in the placement of a compatible DBS Lead when the lead is connected to the cleared Alpha Omega Disposable Sterile LeadConfirm (K191739) and to the NeuroSmart System. This feature will allow the user to record through the implanted lead and based on the recordings show simple spectral measures (PSD) within the frequency bands of interest.

Based on the recordings from the lead and the NeuroProbe MicroElectrode recordings, this feature shows the correlation in frequency band between both these recordings.

When the subject device, the NeuroSmart incorporated the installed Navigation tool is connected to the internet, the relevant intraoperative data collected during DBS surgery can be uploaded to Alpha Omega's cloud by the physician for Neurologist use. This information will assist the Neurologist in programming the Implantable Pulse Generator (IPG).

The Navigation Tool SW can work in two modes:

• 1. The Navigation Tool can be installed on the Neuro Omega/ NeuroSmart Systems.
• 2. The Navigation Tool can work as a standalone software, for that purpose it can be installed on external PC to work in off-line mode.

In both modes the safety and effectiveness of the Neuro Omega and NeuroSmart systems are not compromised, as the Navigation Tool software is a non-blocking software (it doesn't affect the system's functionality even in malfunction). The Navigation Tool software can run in both modes without affecting the Neuro Omega system safety and effectiveness, nor its functionality.

The main use of the Navigation tool SW when it runs as a standalone software, is for visual purpose only, meaning to receive data from the systems and present it in graphs. No changes are made to the retrieved data. Furthermore, the data will be used for verification only for the neurologist prior to fine-tuning the IPG work mode by using the IPG interface (not Alpha Omega's device).

The Navigation Tool provides an option to upload raw data and OR reports to the Alpha Omega server.

• . The raw data include the MER .mpx files and the workspace files that were saved during the surgery by the Neuro Omega or NeuroSmart system (if enabled by the user).
• The OR report includes all the HaGuide parameters, OR notes, stimulation . assessments, and lead recording.

The Alpha Omega server adheres to industry cybersecurity standards.

The Navigation Tool Software in both its modes, as a standalone software and a software installed on Neuro Omega/NeuroSmart systems, can upload data for storage via secured protocols (FTPS, HTTPS) to Alpha Omega server using the internet connectivity.

Neuro Omega/NeuroSmart software does not upload data to any web server. They are able to connect locally to the Navigation Tool, which is the only channel through which data can be uploaded to Alpha Omega server. The Navigation Tool cannot download or retrieve any data from Alpha Omega server.

The provided text describes the regulatory clearance (K220553) for the "Neuro Omega System" and "NeuroSmart System," both incorporating the "Navigation Tool software." The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (Neuro Omega system K171581 and NeuroSmart System K172042). The primary changes appear to be software updates (bug fixes and internet connectivity for the Navigation Tool) and the addition of the Navigation Tool software itself.

Here's an analysis of the acceptance criteria and supporting study information based on the provided text:

Key Takeaway: The document describes a substantial equivalence submission, which relies on non-clinical performance testing (software verification, cybersecurity, EMC) to ensure that the modifications do not raise new safety or effectiveness concerns compared to the predicate devices. It does not contain information about clinical studies (e.g., MRMC studies, human reader improvement with AI assistance, standalone performance on a clinical test set).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided FDA document focuses on engineering and software verification tests rather than clinical performance metrics in terms of diagnostic accuracy or reader improvement. The "acceptance criteria" presented are primarily for technical functionality and regulatory compliance.

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

The document does not specify a "test set" in the context of clinical data or patient cases. The tests described are non-clinical verification and validation activities conducted on the device hardware and software functionalities. Therefore, sample sizes for such tests would relate to the number of test cases executed rather than patient data. No information is provided regarding the country of origin or whether any data used for internal testing was retrospective or prospective.

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

Not applicable. This device submission focuses on substantial equivalence based on engineering and software performance tests, not on diagnostic accuracy requiring expert ground truth establishment from patient data.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are primarily functional and regulatory compliance checks, not clinical studies requiring adjudication of results against a medical ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document makes no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission is for substantial equivalence of an updated neurophysiological recording and stimulation system with added software functionalities, not for an AI-assisted diagnostic tool designed to improve human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The "Navigation Tool SW" can work in two modes:

1. Installed on the Neuro Omega/NeuroSmart Systems.
2. As a standalone software, installed on an external PC to work in off-line mode for visual purpose only (meaning to receive data from the systems and present it in graphs). No changes are made to the retrieved data. The data will be used for verification only for the neurologist prior to fine-tuning the IPG (Implantable Pulse Generator) work mode by using the IPG interface (not Alpha Omega's device).

While there is a "standalone" mode for the Navigation Tool, it is explicitly stated that its purpose is for "visual purpose only" and data presentation, not for making standalone diagnostic or treatment recommendations, nor does it perform "algorithm only" performance in a clinical diagnostic sense that would require a dedicated standalone performance study. The core function of the Neuro Omega and NeuroSmart systems remains recording and stimulation.

7. The Type of Ground Truth Used

For the non-clinical performance and regulatory compliance tests described, the "ground truth" implicitly refers to:

• Pre-defined functional requirements and specifications (for software GUI, graph functionality, settings, etc.).
• Industry standards (ISO 13485, ISO 14971, IEC 60601-1-2).
• Regulatory guidelines (FDA Guidance for coexistence, NIST SP 800-115, OSSTMM, OWASP for cybersecurity, FCC regulations).

No clinical "ground truth" (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for the evaluation presented in this document.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the development or training of any machine learning or AI models. The Navigation Tool software provides functionalities like detecting STN regions and providing stimulation location recommendations, but the underlying methodology (e.g., rule-based, signal processing, or statistical) and any associated training data are not discussed. The submission focuses on verification of the software's functionality and safety, not on its learning capabilities or dataset-driven performance.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set or machine learning/AI model training is described in the provided document.

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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:

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The Neuro Omega System, including the NeuroDrive 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 Neuro Omega System 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 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 device is intended for use by medical personnel within a hospital, 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.

Not Found

This document is a 510(k) clearance letter for the Neuro Omega System. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document confirms that the FDA has reviewed the premarket notification and determined the device to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot provide the requested information based on the input text.

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