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510(k) Data Aggregation
(30 days)
Alpha Omega Engineering Ltd.
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:
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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).
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To measure, record, and display the electrical activity of the patient's brain obtained from two or more electrodes on the head (EEG).
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To measure, display and record the electrical activity of the patient's brain obtained from ECOG strip and grid electrodes.
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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:
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- The HaGuide Software can be installed on the Neuro Omega/NeuroSmart PC and used on the system.
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- 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
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Software / System Verification | The acceptance criteria were defined according to the use cases and regressions tests performed by the Neuro Omega / NeuroSmart systems, to ensure proper functionality: |
- 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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(200 days)
Alpha Omega Engineering Ltd.
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).
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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:
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- The Navigation Tool can be installed on the Neuro Omega/ NeuroSmart Systems.
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- 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.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Software/System Verification | Internet Connectivity works according to its intended use without interrupts to the Neuro Omega/NeuroSmart Software incorporated with Navigation Tool software. | All tests passed the acceptance criteria, determining the effectiveness of Neuro Omega/NeuroSmart System with Navigation Tool software. |
| Functionality of the GUI of the Navigation Tool Software works according to its intended use. | All tests passed the acceptance criteria. | |
| Functionality of the NRMS and PSD Graphs of the Navigation Tool Software works according to its intended use. | All tests passed the acceptance criteria. | |
| Functionality of the HaGuide settings in the Navigation Tool Software works according to its intended use. | All tests passed the acceptance criteria. | |
| Recommendation window functionality verification of the improved HaGuide feature in the Navigation Tool Software. | All tests passed the acceptance criteria. | |
| Lead Correlation feature functionality in the Navigation Tool Software (Online Lead Correlation). | All tests regarding the Online Lead Correlation feature passed the acceptance criteria. (Note: Offline lead correlation analysis feature observed as a bug, but noted as not clinically used during surgeries). | |
| Functionality of the General settings in the Navigation Tool Software works according to its intended use. | All tests passed the acceptance criteria. | |
| Coexistence Testing | The Neuro Omega and NeuroSmart successfully pass the coexistence testing to verify that other devices do not harm the uploading process. The Neuro Omega and NeuroSmart systems operate normally when the connection is down. | All tests passed the acceptance criteria. |
| Cybersecurity | All security check-ups meet/exceed the requirements for all well-known and established regulatory and compliance standards (based on NIST SP 800-115, OSSTMM, OWASP). | All tests passed the acceptance criteria. |
| Electromagnetic Compatibility | Neuro Omega PC supplier meets IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic Compatibility. | The Neuro Omega PC passed with no deviation. |
| NeuroSmart PC is certified Federal Communications Commission (FCC) according to US CFR Title 47, FCC. | Certified Federal Communications Commission (FCC) NeuroSmart PC with no deviation. | |
| The Neuro Omega/NeuroSmart fulfill the requirements of IEC 60601-1-2:2014 (fourth edition) for electromagnetic compatibility. | All tests passed the acceptance criteria (Neuro Omega EMC Report E194610.00, Neuro Omega Medical IEC 60601-1-2 2014, NeuroSmart EMC Report E197560.00). |
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:
- Installed on the Neuro Omega/NeuroSmart Systems.
- 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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(188 days)
Alpha Omega Engineering Ltd.
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:
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- Sterile LeadConfirm M Cable that connects to Medtronic Lead P960009 (3389, 3387)
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- Sterile LeadConfirm B Cable that connects to Boston Scientific Lead P150031 (BSC-DB-2201, BSC-DB-2202)
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- 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:
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- Sterile LeadConfirm M Adaptor
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- 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:
| Acceptance Criteria (Implied from tests) | Reported Device Performance |
|---|---|
| Verification and Validation: | |
| Meets design input specifications for complete Sterile LeadConfirm devices. | "Sterile LeadConfirm devices have been verified under a complete verification plan traceable to Sterile LeadConfirm design input. All samples passed the acceptance criteria which determines the effectiveness of Sterile LeadConfirm devices." (Implied: Design inputs were met, and effectiveness was confirmed.) |
| Sterilization Validation (LeadConfirm Adaptors): | |
| Effectiveness of Gamma Radiation Sterilization for adaptors at specified dose and SAL. | "The purpose of the study was to validate the effectiveness of the Gamma Radiation Sterilization for Alpha Omega Engineering Ltd. LeadConfirm adaptors, according to VDmax Method. According to the test results (section 13), the gamma radiation sterilization process of LeadConfirm Adaptors Cat. No. STR-000071-00, STR-000072-00 and STR-000073-00, at a sterilization dose of 20kGy, was sustained. This dose gave a SAL of 6 magnitudes as requested by the standards." (Result: Sterilization effective, SAL of 10^-6 achieved at 20kGy.) |
| Sterilization Validation (LeadConfirm B Cable): | |
| Effectiveness of Gamma Radiation Sterilization for B Cable at specified dose and SAL. | "The purpose of the study was to validate the effectiveness of the Gamma Radiation Sterilization for LeadConfirm B Cable, according to Vdmax Method. According to the test results (Section 13), the gamma radiation sterilization process of Electrodes lead cable, at a sterilization dose of 20kGy, was sustained. This dose gave a SAL of 6 magnitudes as requested by the standards." (Result: Sterilization effective, SAL of 10^-6 achieved at 20kGy.) |
| Sterilization Validation (LeadConfirm M & A Cables): | |
| Effectiveness of Gamma Radiation Sterilization for M & A Cables at specified dose and SAL. | "The purpose of the study was to validate the effectiveness of the Gamma Radiation Sterilization for LeadConfirm M & A Cables, according to Vdmax Method. According to the test results (Section 13), the gamma radiation sterilization process of Electrodes lead cable, at a sterilization dose of 20kGy, was sustained. This dose gave a SAL of 6 magnitudes as requested by the standards." (Result: Sterilization effective, SAL of 10^-6 achieved at 20kGy.) |
| Integrity of materials and functionality after sterilization: (Implied from comparison) | "Functionality and materials stability, including packaging verified, after irradiation sterilization." (Comparison with predicate states "Identical", implying the subject device also maintained integrity.) |
| Sterility achievement method: (Implied from comparison) | "Sterilized by Alpha omega using irradiation sterilization and delivered sterile, validated process." (Comparison with predicate states "Identical", implying the subject device also uses this method and validated process.) |
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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(236 days)
Alpha Omega Engineering Ltd.
The NeuroNav System / NeuroSmart System, incorporated the installed HaGuide software, is intended to be used in assisting neurosurgeons, in the operating functional neurosurgery, and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrode.
The NeuroNav Drive is intended to be used in assisting neurosurgeons, in the operating room during functional neurosurgery, to aid in the placement of depth electrodes.
Alpha Omega's NeuroNav System is an accurate electrodes navigation system to aid the neurosurgeon in placement of DBS electrodes. The system is designed to be used in the operating room during neurosurgery.
The NeuroNav Drive system is designed for compatibility with Alpha Omega's Microprobes (NeuroProbes K120098) or with other manufacturers' compatible electrodes, and is compatible with all the existing Stereotactic Frames and Frameless procedures.
NeuroNav system can record signals from the brain cells (Micro-Electrode Recording -MER) or stimulate the brain target zone during movement disorders neurosurgery procedure.
In addition, the NeuroNav system is planned to include additional sub model, will be traded as "NeuroSmart", this sub model is identical to the NeuroNav system, the subject device, and incorporated the installed HaGuide software, will be elaborated hereunder.
The installed HaGuide software is 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 provided text describes a 510(k) premarket notification for the NeuroNav System, NeuroSmart System, and NeuroNav Drive. The key focus for this request is the "HaGuide Clinical Study" which assesses the performance of the HaGuide software module.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the HaGuide software's performance, but rather presents the results of a single-arm study evaluating its accuracy against expert measurements. Based on the "Primary Effectiveness Endpoint Analysis" and "Results" section of the HaGuide Clinical Study, an implicit acceptance goal was likely a high percentage agreement and strong correlation.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| High Percent agreement between HaGuide software measurements and expert Neurosurgeon/Electrophysiologist measurements for STN entry point vs. exit point depth. | Percent agreement between HaGuide and Neurosurgeon/Electrophysiologist expert is 90.34% (95% CI, 85.27, 93.85 %). |
| Strong Correlation between HaGuide measurements and expert Neurosurgeon/Electrophysiologist measurements in depth of STN entry site and exit site. | Correlation between the HaGuide measurements and expert Neurosurgeon/Electrophysiologist measurements in depth of STN entry site and exit site was very strong (coefficient = 0.9492 and 0.9317 respectively and both lower 95% Confidence Limit >0.91). |
| Low average difference between HaGuide and expert measurements (Bland-Altman analysis) for STN entry and exit points. | Bland-Altman analysis of average against the difference between HaGuide and expert measurements for the location of STN entry was 0.18 mm (95% CI, -0.9, 1.2 mm) and exit points was -0.15 mm (95% CI, -1.25, 1 mm). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 81 patients, leading to 105 surgeries and 213 electrodes evaluated.
- Data Provenance: Retrospective, Multi-centre, with data collected from both the United States and Outside United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not explicitly stated as a number, but referred to as "qualified user (Neurosurgeon/Electrophysiologist)".
- Qualifications of Experts: Neurosurgeon/Electrophysiologist. No specific years of experience are provided, but they are described as "qualified users."
4. Adjudication Method for the Test Set
The document implicitly describes the adjudication method as a direct comparison between the "HaGuide software measurements" and "expert Neurosurgeon/Electrophysiologist measurements." There is no mention of a formal multi-reader adjudication process like 2+1 or 3+1; the expert opinion is considered the "gold standard."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the accuracy of the algorithm (HaGuide software) compared to expert opinion (the "gold standard"), not on how human readers' performance improves with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was done. The "HaGuide Clinical Study" specifically evaluates the "HaGuide software module accuracy" by comparing its measurements directly against expert measurements, indicating that the algorithm's performance was assessed independently of active human-in-the-loop use.
7. The Type of Ground Truth Used
The ground truth used was expert consensus/opinion. 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."
8. The Sample Size for the Training Set
The document does not provide information regarding the sample size for the training set used to develop the HaGuide software. The "HaGuide Clinical Study" describes a clinical validation of the software, implying it was already developed when this study was performed.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established, as details about the software's development (including training data and ground truth establishment) are not covered in this 510(k) summary.
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(205 days)
Alpha Omega Engineering Ltd,
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 |
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(116 days)
ALPHA OMEGA ENGINEERING LTD.
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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(152 days)
ALPHA OMEGA ENGINEERING, LTD.
Alpha Omega's Sterile Disposable NeuroProbes for MER devices are intended to be used in neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.
Alpha Omega's sterile Disposable Cannulas for MER are intended for guiding the NeuroProbes in Neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.
Alpha Omega's Sterile Disposable Recording Cables for MER are intended to be used in neurosurgery for connecting NeuroProbes to recording and stimulation device.
Alpha Omega's Sterile Disposable NeuroProbes, Cannulas and Recording Cables for MER are indicated for assisting Neurosurgeons, in the operation room during functional neurosurgery, to aid in placement of depth electrodes.
Sterile Disposables for MER
This appears to be a 510(k) clearance letter from the FDA for a medical device. This type of document typically does not contain the detailed study results, acceptance criteria, or performance metrics that you are requesting.
The letter confirms that the device, "Sterile Disposables for MER" from Alpha Omega Engineering, Ltd., has been found "substantially equivalent" to legally marketed predicate devices. This means it has similar technological characteristics and is intended for the same use as a device already on the market, implying that it is as safe and effective.
To provide the information you asked for, I would need access to the actual 510(k) submission, which is often much more detailed than the clearance letter itself and may contain the studies and data you're looking for.
Based on the provided text, I can only state that none of the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth information, MRMC study, standalone performance) is present.
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(212 days)
ALPHA OMEGA ENGINEERING, LTD.
Alpha Omega NeuroProbes are intended to be used in neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.
Not Found
The provided text is a 510(k) Premarket Notification letter from the FDA to Alpha Omega Engineering, Ltd. regarding their device, the "NeuroProbe."
This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) letter confirms that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This means the device can be marketed, subject to general controls and potentially additional controls if classified as Class II or III.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes for test or training sets.
- Details on data provenance.
- Information on experts used to establish ground truth or adjudication methods.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
- Information about the type of ground truth used or how it was established.
The document's purpose is to grant market clearance based on substantial equivalence, not to detail performance studies or acceptance criteria met by the device.
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