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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 Alpha Omega Disposable Sterile LeadConfirm for MER is intended to be used in neurosurgery for connecting a compatible DBS Lead to a compatible recording and stimulation device.

The Alpha Omega Disposable Sterile LeadConfirm for MER is indicated for assisting Neurosurgeons, in the operating room during functional neurosurgery, to aid in the placement of a compatible DBS Lead.

The Alpha Omega Disposable Sterile LeadConfirm should only be used to connect a compatible DBS Lead to a compatible recording and stimulation device.

Alpha Omega's Sterile LeadConfirm cable and adaptor connects the DBS lead to Alpha Omega's approved physiological navigation systems for recording and stimulation system: Neuro Omega (K171581) and NeuroSmart (K172042).

The purpose of the submission is to introduce the Sterile LeadConfirm Cable and Adaptor, the subject devices are sterile Hardware only.

There are three types of the subject device, Alpha Omega's Sterile LeadConfirm Cables:

• 1. Sterile LeadConfirm M Cable that connects to Medtronic Lead P960009 (3389, 3387)
• 2. Sterile LeadConfirm B Cable that connects to Boston Scientific Lead P150031 (BSC-DB-2201, BSC-DB-2202)
• 3. Sterile LeadConfirm A Cable that connects to Abbott Lead P140009 (6170/ 6171/ 6172/ 6173/ 6178/ 6170/ 6180/ 6181)

In addition, there are two types of Sterile LeadConfirm Adaptors:

• 1. Sterile LeadConfirm M Adaptor
• 2. Sterile LeadConfirm A Adaptor

AOE (Alpha Omega Engineering) stimulation with LeadConfirm cable and adaptor is identical to IPG/ test stimulator, with the following parameters:

• a) Pulse shape: Square wave, Lili pulse
• b) Amplitude up to 12mA
• c) Duration up to 500uSec

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

Disclaimer: This device is a sterile cable and adaptor, not an AI/ML powered device. Therefore, many of the requested criteria for AI/ML device studies (such as MRMC, human-in-the-loop, training set details, and expert qualifications for ground truth) are not applicable to this submission. The information provided focuses on the non-clinical performance validation.

Acceptance Criteria and Device Performance (Non-Clinical)

The "Sterile LeadConfirm" device is a hardware component (cable and adaptor) intended for connecting a Deep Brain Stimulation (DBS) lead to a recording and stimulation device during neurosurgery. The acceptance criteria and performance are focused on the safety and effectiveness of the hardware itself, primarily through verification and sterilization validation.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated as a number of devices or units. The sterilization validation studies mention testing "complete Sterile LeadConfirm Adaptors" or "complete Sterile LeadConfirm B Cable," implying that a representative sample of each type of device was used. Standard sterilization validation protocols (like VDmax method mentioned) involve specific sample sizes based on lot size and desired Sterility Assurance Level (SAL), but the exact number is not provided in this summary.
• Data Provenance: The studies were non-clinical bench tests performed internally by Alpha Omega Engineering Ltd. (Israel). The data is generated from laboratory testing of the physical devices.

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

• Not applicable. This submission is for a hardware medical device (cable and adaptor), not an AI/ML-powered diagnostic or decision support tool. Therefore, there is no "ground truth" in the clinical sense established by human experts for a test set. The validation is based on engineering and microbiology standards for functionality and sterilization.

4. Adjudication Method for the Test Set:

• Not applicable. As this is a non-clinical hardware validation, there is no need for adjudication involving human readers or experts to determine a "truth" for the test results. The results are objective measurements against defined standards.

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

• No. This is not an AI/ML device that interacts with human readers. The effectiveness is determined through physical verification and sterilization validation of the hardware.

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

• Not applicable. This device is hardware and does not contain an algorithm. Performance is assessed through physical and sterility testing.

7. The Type of Ground Truth Used:

• The "ground truth" in this context refers to established engineering standards, design specifications, and internationally recognized sterilization validation methods (e.g., VDmax Method for Gamma Radiation Sterilization) and a Sterility Assurance Level (SAL) of 10^-6. These are objective, scientifically defined criteria, not medically determined "ground truth" from patient data.

8. The Sample Size for the Training Set:

• Not applicable. This is a hardware device; therefore, there is no "training set" in the context of AI/ML.

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

• Not applicable. There is no training set for this hardware device.

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