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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 Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.

The device under review is a family of Anchor Bolts. Anchor Bolts are optional accessories to Depth Electrodes. These Anchor Bolts provide an optional access point through the skull and stabilization support for Depth Electrodes.

The furnished document is an FDA 510(k) Premarket Notification stating substantial equivalence for the "Anchor Bolts as Accessories to Depth Electrodes" device. It outlines the device description, intended use, comparison with a predicate device, and performance data related to its safety in the Magnetic Resonance (MR) environment.

However, the information provided does not describe an AI medical device or a study involving human readers or AI assistance. The performance data is solely for the physical device's safety in an MR environment, not for an AI algorithm's diagnostic or assistive performance.

Therefore, I cannot fulfill your request as it pertains to acceptance criteria and studies for an AI medical device, multi-reader multi-case studies, or AI algorithm performance.

The document discusses the following acceptance criteria and performance for the physical device:

1. Table of Acceptance Criteria and Reported Device Performance

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The AD-TECH Depth Electrodes (Spencer Probe Depth Electrodes) are intended for temporary (

The Depth Electrodes (Spencer Probe Depth Electrode) are intended for recording, monitoring and stimulation at sub-surface levels of the brain. These electrodes are provided sterile, disposable and single patient use. The Depth Electrodes (Spencer Probe Depth Electrodes) provide the patient contact device. The Depth Electrodes (Spencer Probe Depth Electrodes) connect to an electrode cable that is applied to the user's equipment. The electrodes are used by physicians.

Here's a breakdown of the acceptance criteria and the study information for the Spencer Probe Depth Electrodes, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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Senso Medical Depth Electrodes are intended for temporary (

The SENSO SEEG Electrode is a smooth electrode with a diameter of 0.8 - 2 mm with a rounded tip. Different configurations exist with diameters of 0.8, 1.1, 1.27, and 2.0 mm. The electrode contacts are made from stainless-steel that can be 1.5mm, 2.0, and 3.0 mm long, with a total exploration length varying from (22 - 82 mm) according to the electrode reference. The total length of the electrodes range from 360 mm to 410 mm long depending on the number of contacts and total exploration length of the electrodes. The electrodes come in 3 main configurations, but can be customized to the parameters mentioned above based on the application need.

This FDA 510(k) summary provides information on the SENSOSEEG Depth Electrodes. However, it does not include detailed acceptance criteria or a study that specifically proves the device meets those criteria in the typical format of a diagnostic algorithm's performance study.

This document is a premarket notification for a medical device (depth electrodes), not a diagnostic algorithm. Therefore, the "acceptance criteria" and "study" described are focused on the device's physical and functional properties, and its substantial equivalence to predicate devices, rather than on diagnostic performance metrics like accuracy, sensitivity, or specificity common to AI/ML software.

The acceptance criteria are implied by the comparison to predicate devices and the non-clinical testing performed.

Here's an attempt to categorize the information based on your request, keeping in mind the nature of this submission:

1. A table of acceptance criteria and the reported device performance

Since this is a physical medical device (depth electrodes), the "acceptance criteria" are related to its design specifications, material properties, and functional performance, rather than diagnostic accuracy. The "reported device performance" is largely demonstrated by showing equivalence to legally marketed predicate devices through bench testing and material comparison.

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iCE-SG2 Subcutaneous Electrode Kit is intended for temporary (

The iCE-SG2 Subcutaneous Electrode Kit is intended for temporary (

The document describes the iCE-SG2 Subcutaneous Electrode Kit and its substantial equivalence to a predicate device (iCE-SG Subcutaneous Electrode Arrays, K201678). The acceptance criteria and the study that proves the device meets them are primarily focused on biocompatibility and performance (bench), as this is a medical device for recording electrical signals from the brain.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 10 electrodes were used in the cadaver study for performance testing.
• Data Provenance: The document does not explicitly state the country of origin. The study was a "cadaver study," implying human cadavers, and is presented as part of a U.S. FDA 510(k) submission, suggesting it was conducted to U.S. regulatory standards. It is a prospective evaluation of the new device's performance.

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

The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the performance testing. The performance criteria (reproducibility of insertion, stability, removal, and impedance measurements) are objective and measured directly, not subject to expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable, as a traditional ground truth based on expert consensus was not established for the performance testing. The assessment of successful performance was based on pre-specified objective criteria.

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

Not applicable. This device is an electrode kit for recording electrical signals, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the performance study was based on objective, pre-specified criteria and measurements from the cadaver study (e.g., successful insertion, stability, removal, and impedance values). For biocompatibility, it was based on compliance with ISO 10993 standards and a history of safe biological use for components.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm.

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The Evo® sEEG System is intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

The NeuroOne Evo® sEEG System is comprised of the Evo® sEEG Electrodes (which includes Anchor Bolt Cap and Stylet) accompanying Cable Assemblies, and the Evo® Anchor Bolts. The Evo® sEEG System components are provided sterile and are single use only. The Evo® sEEG Electrodes and Anchor Bolts are temporarily placed (less than 30 days) at the subsurface level of the brain. The system is designed to be used in stereoelectroencephalography (sEEG) procedures.

The sEEG electrodes, by way of the accompanying cable assemblies, are connected to recording, monitoring, or stimulation/response instrumentation commercially available for use with other sEEG electrodes, including the predicate device.

The sEEG electrodes are a 0.8mm diameter polyimide electrode with platinum contacts and are available in varying numbers of contacts: 5 to 16 contacts, with an exploration length (recording depth) from 16 to 80mm. The contact height is 2.0mm and spacing is 1.5-3.2mm apart.

The Evo® Anchor Bolts are available in 20mm, 30mm, and 35mm lengths, can only be used and placed through a small 2.1mm burr hole drilled in the skull, and should be used only when sEEG depth electrodes are warranted.

The provided text describes a 510(k) premarket notification for the Evo® sEEG System, focusing on its substantial equivalence to a predicate device, particularly regarding an extended duration of use. The core of the information revolves around biocompatibility testing to support this extended use.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly derived from the ISO standards for biocompatibility testing, where "Pass" indicates meeting the acceptance criteria according to the standard. The reported device performance aligns with these "Pass" conclusions.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions specific tests, some of which imply sample sizes (e.g., "ISO Guinea Pig Maximization Sensitization" and "Chronic (29 Days) GLP Brain Tissue Implantation Study (Sheep)"), but it does not explicitly state the numerical sample sizes for each test. The data provenance (country of origin, retrospective/prospective) is also not explicitly provided in the given text. These were "performance evaluations... conducted to address the proposed extended duration of use" and "biocompatibility testing ... as part of this 510(k)", implying they were conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to the provided document. The study described is a series of biocompatibility tests, not a clinical study involving expert interpretation of medical images or patient outcomes to establish a "ground truth" for a diagnostic device. The "ground truth" here is the biological reaction or material property as determined by standardized laboratory methods (e.g., cytotoxicity, sensitization, implantation response).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods are typically used in clinical trials or studies where human readers independently assess data and then resolve disagreements. The biocompatibility tests are laboratory-based and follow established protocols.

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

This section is not applicable. The device is an sEEG electrode system, not an AI-powered diagnostic tool. The performance studies detailed are physical and biological evaluations of the device material and function, not its interpretative assistance capabilities for human readers.

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

This section is not applicable. As stated above, the device is an sEEG electrode system, not an algorithm, and therefore, an "algorithm only" performance evaluation is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the biological and material reaction observed and measured through standardized laboratory tests (e.g., presence/absence of cytotoxicity, level of irritation, tissue response from implantation). This is derived directly from the results of the specific ISO-standardized tests rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

This section is not applicable. The provided document describes device performance testing for regulatory submission, not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of this submission.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as point 8.

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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 DIXI Medical Microdeep® Micro-Macro Depth Electrodes are intended for temporary (

The Microdeep® Micro-Macro Depth Electrode is a single patient use, sterile and disposable device. The Microdeep® Micro-Macro Depth Electrode is invasive as it is placed in contact with nerve tissue (brain) and must only be used during an SEEG procedure with Anchor Bolts. The Microdeen® Micro-Macro Depth Electrode is intended to connect to the user's recording. monitoring and stimulation equipment using the Connection System. This product is intended to be used only by physicians in the area of biopotential recording, monitoring and stimulation / response studies who are trained in intracranial neurophysiology. The DIXI Medical Microdeep® Micro-Macro Depth Electrode is comprised of the following components: Macro-contacts, Micro-contacts, Microdrive for micro-contacts, Cap, Connectors for micro and macro-contacts.

The provided 510(k) summary for the DIXI Medical Microdeep® Micro-Macro Depth Electrodes details the results of non-clinical testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

• Verification of electrode water tightness
• Verification of cap maintenance on the electrode sheath
• Verification of the antirotation function of electrode cap
• Verification of tensile strength of electrode macro-contacts | Pass |
  | Electrical Characteristics | - Verification of the electrical characteristics (contacts continuity, contacts resistance, absence of short-circuit, insulating resistance)
• Verification of the electrode integrity and electrical functionality after stimulation under worst case charge density | Pass |
  | Device Integrity | - Verification of the absence of alteration of the packaging
• Verification of the absence of alteration of the electrode | Pass |
  | Comparative Testing | - Comparative test of the tensile strength of the micro-contacts between the predicate device and the subject device
• Verification of the integrity and the mechanical functionality of the predicate device and the subject device after clinical simulation of use | Pass |
  | Biocompatibility - Cytotoxicity | Non-cytotoxic (per ISO 10993-5) | Non-cytotoxic |
  | Biocompatibility - Sensitization | Non-sensitive (per ISO 10993-10) | Non-sensitive |
  | Biocompatibility - Irritation or intracutaneous reactivity | Negligible irritation (per ISO 10993-10) | Negligible irritation |
  | Biocompatibility - Acute systemic toxicity | Non-toxic (per ISO 10993-11) | Non-toxic |
  | Biocompatibility - Material-mediated pyrogenicity | Non-pyrogenic (per USP) | Non-pyrogenic |
  | Biocompatibility - Sub-acute toxicity | Non-toxic (per ISO 10993-11) | Non-toxic |
  | Biocompatibility - Genotoxicity – Mouse Lymphoma Assay | Non-genotoxic (per OECD guideline No. 490 and ISO 10993-3) | Non-genotoxic |
  | Biocompatibility - Genotoxicity – Bacterial Reverse Mutation | Non-genotoxic (per OECD guideline No. 471 and ISO 10993-3) | Non-genotoxic |
  | Biocompatibility - Indirect (extract) hemolysis | Non-hemolytic (per ASTM F756 and ISO 10993-4) | Non-hemolytic |
  | Biocompatibility - Implantation and neurotoxicity | No or minimal reaction (per ISO 10993-6) | No or minimal reaction |
  | Sterilization | Sterility Assurance Level (SAL) of 10^-6, EO residuals per ISO 10993-7 (per ISO 11135:2014) | SAL of 10^-6 demonstrated; device meets EO residuals |
  | Shelf-life | Shelf-life established based on accelerated and real-time aging | 4 years established |

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

The document does not explicitly state the specific sample sizes used for each non-clinical test. The tests were performed in a laboratory setting by DIXI Medical. The data provenance is internal to DIXI Medical (France). All data appears to be prospective as it details performance and safety studies conducted specifically for this submission.

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

Not applicable. The tests performed are non-clinical, laboratory-based engineering, material, and biological evaluations. There is no "ground truth" derived from expert review in the clinical sense for these types of tests. The "ground truth" for these tests is the defined engineering specifications, material properties, and biological safety standards (e.g., ISO, USP, ASTM, OECD guidelines).

4. Adjudication Method for the Test Set

Not applicable. As noted above, these are non-clinical laboratory tests, not clinical studies requiring adjudication of output. The results of the tests are objectively measured against pre-defined criteria in the relevant standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (electrode) and relies on non-clinical performance and safety data, as well as a comparison of technological characteristics to a predicate device, rather than a clinical effectiveness study involving human readers and AI.

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

Not applicable. This device is an electrode, not an AI or algorithm-based system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is established by:

• Engineering specifications and standards: For dimensional, mechanical, and electrical characteristics, the "ground truth" is the established design specifications and performance metrics for the device, validated against recognized engineering principles and testing methods.
• International Standards (ISO, ASTM, OECD) and Pharmacopeia (USP): For biocompatibility, sterilization, and shelf-life, the "ground truth" is defined by the requirements and acceptance criteria outlined in specific international standards and guidelines (e.g., ISO 10993 series, ISO 11135, USP).

8. The Sample Size for the Training Set

Not applicable. This device is an electrode, not an AI or algorithm-based system, so there is no training set in the context of machine learning.

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

Not applicable, as there is no training set for this device.

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The Evo sEEG System is intended for temporary (less than 24 hours) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

The NeuroOne Evo sEEG System is comprised of the Evo sEEG Electrodes (which includes Anchor Bolt Cap and Stylet) accompanying Cable Assemblies, and the Evo Anchor Bolts. The Evo sEEG System components are provided sterile and are single use only. The Evo sEEG Electrodes are temporarily placed (less than 24 hours) at the subsurface level of the brain. The system is designed to be used in stereoelectroencephalography (sEG) procedures. The sEEG electrodes, by way of the accompanying cable assemblies, are connected to recording, monitoring, or stimulation/response instrumentation currently commercially available for use with other sEEG electrodes, including the predicate device. The sEEG electrodes are a 0.8 mm diameter polyimide electrode with platinum contacts and are available in varying numbers of contacts: 5 to 16 contacts, with an exploration length (recording depth) from 16 to 80 mm. The contact height is 2.0 mm and spacing is 1.5-3.2 mm apart. The Evo Anchor Bolts are available in 20 mm, 25 mm, 30 mm, and 35 mm lengths, can only be used and placed through a small 2.1 mm burr hole drilled in the skull, and should be used only when sEEG depth electrodes are warranted.

The NeuroOne Evo sEEG System, a depth electrode for temporary brain electrical signal recording, monitoring, and stimulation, has been deemed substantially equivalent to its predicate device, the DIXI Medical Microdeep Depth Electrode. This determination is based on a comprehensive set of performance tests.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list specific quantitative acceptance criteria for each test. Instead, for all "Non-Clinical Performance Tests," "Biocompatibility" tests, and a "Simulated Use and Implantation Accuracy Study," the reported performance is a concise "Pass – All samples passed the acceptance criteria" or similar statements like "Pass - Non-cytotoxic," "Pass - Did not elicit a sensitization response," etc. This indicates that predefined criteria were met for each test, but the exact numerical thresholds are not provided in this summary.

Summary of Performance Testing and Results:

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

• Non-Clinical Performance, Biocompatibility, Sterility, Shelf-Life, and Packaging Tests: The document consistently states "All samples passed the acceptance criteria" for these tests, implying multiple samples were tested for each. However, the exact sample sizes for each individual test are not specified.
• Simulated Use and Implantation Accuracy Study: The sample size is not explicitly stated, but it was a "human cadaver study." The data provenance is implied to be from a controlled laboratory setting (conducted by NeuroOne Medical Technologies Corp.) rather than clinical data from a specific country, and it is a prospective study (testing the device).

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

• Non-Clinical Performance, Biocompatibility, Sterility, Shelf-Life, and Packaging Tests: These types of tests typically rely on established scientific and engineering standards and validated methodologies rather than expert consensus for ground truth. The "ground truth" would be the fulfillment of the specified technical criteria within the standards. Therefore, an explicit number of experts and their qualifications for establishing ground truth as one might see in a clinical algorithm study is not applicable here.
• Simulated Use and Implantation Accuracy Study: The document does not specify the number or qualifications of experts used to establish the ground truth for implantation accuracy in the human cadaver study. The comparison was made against the predicate device, implying that accuracy was measured objectively according to predefined metrics.

4. Adjudication Method for the Test Set:

• For the non-clinical tests, the adjudication method is via comparison to predefined acceptance criteria within established standards (e.g., ISO, ASTM, IEC). This is typically an objective pass/fail assessment rather than a human adjudication process.
• For the "Simulated Use and Implantation Accuracy Study," the adjudication method is not explicitly stated. The conclusion that "no significant difference" was found implies a statistical comparison of measured implantation accuracy between the subject and predicate devices. No human adjudication process (like 2+1 or 3+1) is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned. The study focused on demonstrating substantial equivalence through technical and performance characteristics, and a simulated use study comparing the subject device to a predicate, not on human reader performance with or without AI assistance. The device itself is an implantable electrode, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

This concept is not relevant to the Evo sEEG System, as it is a physical medical device (electrode) and not an algorithm or software-only device. Performance studies were conducted on the device's physical and electrical characteristics.

7. Type of Ground Truth Used:

• Non-Clinical Performance, Biocompatibility, Sterility, Shelf-Life, and Packaging Tests: The ground truth for these tests is based on adherence to established international and national standards (e.g., ISO, ASTM, IEC) and internal specifications. This is objective and measurable data compared against predefined thresholds.
• Simulated Use and Implantation Accuracy Study: The ground truth for implantation accuracy would be derived from objective measurements taken within the cadaver study, comparing the planned trajectory/placement with the actual placement, likely using imaging modalities.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable as this is a physical medical device, not a machine learning algorithm that requires training data.

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

This question is not applicable, as there is no training set for this device.

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iCE-SG Subcutaneous Electrode Arrays are intended for temporary (

The iCE-SG Subcutaneous Electrode Arrays are intended for use with recording and monitoring equipment for the purpose of recording electroencephalograph (EEG) signals. The subject device allows for continuous EEG monitoring in the subcutaneous space. The iCE-SG Subcutaneous Electrode Arrays can connect to commonly used electrophysiology systems. The subject device is provided sterile and for single patient use in hospitals by healthcare professionals (HCPs).

A kit includes the following components:

1. Preparation box
2. Insertion kit box
3. Two iCE-SG electrode boxes

Here's an analysis of the acceptance criteria and supporting study for the iCE-SG Subcutaneous Electrode Arrays, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format for device performance. Instead, it details various tests to demonstrate safety and equivalence to a predicate device. The "results" column below reflects the outcomes reported for these tests, which were deemed sufficient for demonstrating substantial equivalence.

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