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Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) are intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older.

The Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1 (herein collectively referred to as "Rapid2 Magnetic Stimulators") are computerized, electromechanical medical devices that provide brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older. The subject device is intended to be used in hospitals and clinics such as pain management clinics.

Rapid2 Magnetic Stimulators are integrated systems consisting of a combination of hardware, software, and accessories. Rapid2 Magnetic Stimulators are offered in multiple configurations:

• Rapid2
• Super Rapid2
• Super Rapid2 Plus1

All three configurations have identical intended use/indications for use, common specifications, equivalent performance characteristics and equivalent composition to each other. Specifically, Rapid2 and Super Rapid2 have received prior clearance under K051864 for Peripheral Nerve Stimulation (Product Code: GWF, Regulation 21 CFR 882.1870). All Rapid2 Magnetic Stimulators are made up of components that have received prior clearance under K051864 (e.g., the 3190-00, 3192-00 and 3193-00 coils) and components which have received prior clearance under K051864 but have received modifications due to aspects like obsolescence (Mainframe, Power Supply etc.).

All Rapid2 Magnetic Stimulators are composed from the following main components:

• Stimulating Unit & Power Supply
• User Interface
• Stimulating Coil
• System and Stimulating Coil Cart and Holding Arm

Rapid2 Magnetic Stimulators include temperature monitoring via two independent temperature sensors to ensure surfaces of the coils do not reach unacceptable levels. The cut-off is set to act at 40°C at which point the system will automatically be disabled. Over-temperature conditions are also communicated on the User Interface (UI) via a temperature gauge and alarm system. Rapid2 Magnetic Stimulators also includes the 3910-00 air-cooled coil to further mitigate any temperature conditions. The 3910-00 air-cooled coil comes with all 3 configurations (Rapid2, Super Rapid2 and Super Rapid2 Plus1) as standard.

The provided document is an FDA 510(k) Clearance Letter for the Rapid2 Magnetic Stimulators. It does NOT contain information about a study proving the device meets acceptance criteria related to its performance in pain relief. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of technical characteristics, safety standards compliance, and physical properties.

The document does not describe an AI/ML-driven device, nor does it present results from a clinical study with patients or human readers using AI. The acceptance criteria and performance metrics described are related to physical and electrical characteristics of the magnetic stimulator, not diagnostic accuracy or clinical effectiveness in a traditional sense of "performance" as one might expect for an AI diagnostic device.

Therefore, many of the requested items (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, ground truth type) cannot be answered based on the provided text, as they pertain to clinical or AI/ML performance evaluation, which is not the subject of this 510(k) summary.

However, I can extract information related to the technical acceptance criteria and how they align with the device's measured performance as described in the summary:

Acceptance Criteria and Device Performance (Based on Technical and Safety Equivalence)

The acceptance criteria for the Rapid2 Magnetic Stimulators are primarily based on demonstrating substantial equivalence to the predicate device (MagVenture Pain Therapy) in terms of technical characteristics, safety, and effectiveness for the stated indications for use. The "performance" reported is adherence to these characteristics and safety standards.

Regarding the specific questions that cannot be answered from the provided text:

2. Sample sizes used for the test set and the data provenance: Not applicable or provided. The "test set" here refers to non-clinical testing of device characteristics, not a clinical study on patients or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. Ground truth in this context would implicitly be engineering specifications, laboratory measurements, and standard compliance testing, not expert clinical assessment of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided. No adjudication process detailed for establishing technical specifications.
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 is not an AI/ML device, nor is it a diagnostic device being evaluated for reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance evaluation is based on engineering specifications, direct physical measurements (e.g., of magnetic fields, temperatures, electrical properties), and compliance with international safety and performance standards (e.g., IEC 60601 series, ISO 10993).
8. The sample size for the training set: Not applicable or provided. This device does not use a "training set" in the machine learning sense.
9. How the ground truth for the training set was established: Not applicable or provided.

In summary, the provided document details the 510(k) clearance process for a non-AI/ML magnetic stimulator for pain relief. The "acceptance criteria" and "performance" are framed around demonstrating substantial technical and safety equivalence to a legally marketed predicate device, rather than clinical efficacy data from patient studies or AI algorithm performance metrics.

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The Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300. Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The Nicolet EDX with Natus Elite Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The Nicolet EDX with Natus Elite Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The Nicolet EDX with Natus Elite Software is intended to be used by a qualified healthcare provider.

The Nicolet EDX system is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform Nerve Conduction (NCS), Electromyoaraphy (EMG), Evoked Potentials (EP), and Autonomic Responses. Nicolet EDX system provides a variety of tests spanning the various modalities.

The Nicolet EDX system consists of the following major components:

• Base unit
• Amplifier (2- or 8-channel)
• Control panels
• Computer- laptop or desktop (with display, keyboard and mouse)
• Display Monitor (for desktop system)
• Application Software (Natus Elite)

The Nicolet EDX optional accessories/ components consist of the following:

• Audio stimulators (Headphones or other auditory transducers)
• Visual stimulators (Natus Visual Stimulator, LED goggles or stimulus monitor)
• Electrical stimulators (RS10 comfort probe, WR50 comfort probe plus)
• Cart and associated accessories (such as arms, mounts and isolation transformer
• Miscellaneous options and accessories such as Patient Response button. Single/Triple footswitch, Tendon (Reflex) hammer, Natus photic stimulator, temperature probe, ultrasound device, bone conductor, printer, etc.

The electrodiagnostics system is powered by a connection to mains.

The entire user interface of Nicolet EDX system consists of two major elements:

• The primary means to interact with the system is via a personal computer (PC) running Natus Elite.
• The second means of interaction is the user interface elements on the hardware.

The Nicolet EDX is intended to be used by a qualified healthcare provider. This device does not provide any diagnostic conclusion about the patient's condition to the user. The intended use environment is in a professional healthcare facility environment.

This FDA 510(k) summary for the Nicolet EDX device does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and study design.

However, based on the provided text, here's what can be extracted and inferred:

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

The document does not explicitly state "acceptance criteria" for the device's clinical performance with quantitative metrics. Instead, it compares the technological characteristics of the Nicolet EDX to predicate devices, implying that meeting or being substantially equivalent to these characteristics demonstrates acceptable performance.

Here's a table summarizing the technological characteristics described as identical or similar to predicate devices, which serve as an implicit benchmark for acceptance:

The study proving the device meets the acceptance criteria is detailed by the statement: "Verification and validation activities were conducted to establish the performance and safety characteristics of the Nicolet EDX. The results of these activities demonstrate that the Nicolet EDX is safe, effective, and performance is substantially equivalent to the predicate devices."

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

This information is not provided in the document. The 510(k) summary focuses on "substantial equivalence" based on technological characteristics and general verification/validation, rather than a clinical study with a specific test set, patient data, and provenance.

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 information is not provided as a detailed clinical study with ground truth established by experts is not described in this summary. The device is for electrophysiological information acquisition and analysis, where "ground truth" often refers to the actual physiological signals or clinical diagnoses, which would typically be assessed by qualified healthcare providers using established medical guidelines.

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

This information is not provided as a formal clinical study with adjudication of a test set is not detailed.

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

An MRMC study is not mentioned in this summary. The device description explicitly states: "This device does not provide any diagnostic conclusion about the patient's condition to the user." It is a diagnostic aid for acquiring and analyzing physiological information, not an AI-driven interpretive tool that would typically undergo MRMC studies to assess human reader improvement.

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

A standalone algorithm performance study is not mentioned. The device is an electrodiagnostic system with software, but the summary does not present it as an autonomous AI system requiring standalone performance evaluation in the classification sense. Rather, it emphasizes its role as a tool for a "qualified healthcare provider."

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

Since a specific clinical study with a detailed test set is not described, the type of ground truth used is not specified. For a device like this, the "ground truth" for performance validation would likely involve:

• Technical Benchmarking: Verification that the electrical signals acquired and processed meet specified technical parameters by comparing them to known or simulated physiological signals, or against established high-fidelity measurement systems.
• Clinical Utility Confirmation: Ensuring that the output provides information that is consistent with expected physiological responses and is interpretable by healthcare professionals for supporting diagnosis.

8. The sample size for the training set

This information is not provided. This summary does not indicate that the device uses machine learning or AI models that require a "training set" in the conventional sense. The "Natus Elite Software" is application software for data acquisition, display, and analysis, not necessarily a predictive AI model requiring a distinct training dataset.

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

As no training set is mentioned, the method for establishing its ground truth is not applicable/provided.

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The UltraPro is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including Nerve Conduction (NCS), Electromyography (EMG), Evoked Potentials (EP), Autonomic Responses and Intra-Operative Monitoring including Electroencephalography (EEG).

Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300. Motor Evoked Potentials (MEP) and Contingent Negative Variation (CNV). The UltraPro with Natus Elite Software may be used to determine autonomic responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes (Galvanic Skin Response and Sympathetic Skin Response). Autonomic testing also includes assessment of RR Interval variability. The UltraPro with Natus Elite Software is used to detect the physiologic function of the nervous system, for the location of neural structures during surgery, and to support the diagnosis of neuromuscular disease or condition.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the nerve; Electromyography measures the electrical activity of the muscle and Evoked Potentials measure electrical activity from the Central Nervous System.

The UltraPro with Natus Elite Software is intended to be used by a qualified healthcare provider.

The UltraPro S100 system is designed for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems. The system is designed to perform Nerve Conduction (NCS). Electromyography (EMG), Evoked Potentials (EP), and Autonomic Responses. UltraPro S100 system provides a variety of tests spanning the various modalities.

The UltraPro S100 system consists of the following major components:

• Main unit (also known as base unit or main base unit) with integrated control panel; ●
• Amplifier (3- or 4-channel);
• . Computer- laptop or desktop (with keyboard and mouse)
• Display Monitor (for desktop system)
• . Application Software (Natus Elite)

The UltraPro S100 has the following optional accessories/ components:

• Audio stimulators (Headphones or other auditory transducers)
• Visual stimulators (LED goggles or stimulus monitor)
• . Electrical stimulators (RS10 probes, stimulus probe with controls)
• Cart and associated accessories when using cart such as isolation transformer
• Miscellaneous accessories such as Patient Response button, Triple footswitch, Reflex hammer, temperature probe and adapter, ultrasound device, printer, etc.

The electrodiagnostics system is powered by a connection to mains.

The entire user interface of UltraPro S100 system consists of two major elements:

• The primary means to interact with the system is via a personal computer (PC) running ● Natus Elite.
• The second means of interaction is the user interface elements on the hardware.

The UltraPro S100 is intended to be used by a qualified healthcare provider. This device does not provide any diagnostic conclusion about the patient's condition to the user. The intended use environment is in a professional healthcare facility environment.

The provided text is a 510(k) Summary for the Natus Ultrapro S100 device. While it describes the device's indications for use and compares its technological characteristics to predicate devices, it does not contain information about the acceptance criteria or the specific study that proves the device meets those criteria, such as a clinical performance study with defined metrics like sensitivity, specificity, or accuracy. This document focuses on demonstrating substantial equivalence to a predicate device primarily through technical specifications and intended use.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes used for test/training sets, data provenance, number or qualifications of experts, adjudication methods, or details about MRMC or standalone studies based on the provided text. The document is primarily a comparison of features and intended use.

The "Conclusion" section on page 14 states: "Verification and validation activities were conducted to establish the performance and safety characteristics of the UltraPro S100. The results of these activities demonstrate that the UltraPro S100 is safe, effective, and performance is substantially equivalent to the predicate devices." However, it does not elaborate on what these activities entailed or the specific criteria and results.

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The Delphi Stimulator is intended to be used for stimulation of peripheral nerves for diagnostic purposes.

Delphi stimulator is a Magnetic stimulator used for Magnetic stimulation of peripheral nerves for diagnostic purposes. Magnetic stimulation is a non-invasive technique for stimulating neural tissue. Application areas of magnetic stimulation are a sub-set of the application areas for current stimulation. The Delphi stimulator is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue.

The stimulator consists of power electronics to generate the magnetic field in the Magnetic Coil. It is controlled via a user interface installed on a PC workstation connected to the stimulator. enabling the operator to overview all functions, stimulus sequences, controls, status and measured data. The magnetic pulse is Biphasic waveform and the stimulator can stimulate with a frequency of up to 3 pulses per second (pps).

The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria in the format requested. The document is an FDA 510(k) summary for the "Delphi Stimulator," which focuses on demonstrating substantial equivalence to a predicate device.

The "Performance Data" section (Section 10) lists various tests performed, but these are primarily bench tests for substantial equivalence, electrical safety, EMC, and software validation. It does not present specific acceptance criteria (e.g., minimum sensitivity or specificity targets) or a clinical study with human subjects to evaluate the device's diagnostic performance against such criteria.

The information provided is as follows:

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

• No explicit table of acceptance criteria with corresponding device performance for diagnostic accuracy (e.g., sensitivity, specificity) is provided.
• The document mentions "Stimulation output comparison to Predicate" where the results "demonstrated substantial equivalency." This is a comparison for substantial equivalence, not a performance metric against a set acceptance criterion.

2. Sample size used for the test set and the data provenance:

• Not applicable. No clinical test set involving patient data is described. The performance data refers to nonclinical bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical test set requiring expert-established ground truth is described.

4. Adjudication method for the test set:

• Not applicable. No clinical test set requiring adjudication is described.

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 a stimulator for diagnostic purposes, not an AI-powered diagnostic system that assists human readers.

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

• Not applicable. This device is a stimulator, not an algorithm.

7. The type of ground truth used:

• Not applicable. For the bench tests performed, the "ground truth" would be the expected electrical and magnetic outputs, and adherence to safety and software standards, which were verified directly rather than against a clinical ground truth.

8. The sample size for the training set:

• Not applicable. This document describes a medical device, a stimulator, not a machine learning or AI model that requires a training set.

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

• Not applicable. As above, this document does not refer to a machine learning or AI model.

Summary of available "Performance Data" from the document:

In conclusion, the document describes non-clinical bench tests and adherence to safety and software standards to support the substantial equivalence claim, rather than a clinical study evaluating diagnostic performance against specific acceptance criteria.

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The SafeOp 3: Neural Informatix System is intended for use in monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open/percutaneous, lumbar, thoracic, and cervical surgical procedures.

SafeOp 3 Accessories: The SafeOp Accessories are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

The SafeOp™ 3: Neural Informatix System (SafeOp 3 System), consists of the SafeOp patient interface with power supply and IV pole mount, the Alpha Informatix Tablet with docking station and power supply and a data transfer USB cable. Associated disposable accessories consists of an electrode harness, surface and/or subdermal needle electrodes, MEP Activator, Cranial Hub, PMAP Dilators and stimulating probe or clip contained in various kits.

The subject device is intended for use by trained healthcare professionals, clinical neurophysiologists/technologists and appropriately trained non-clinical personnel. The subject device is intended for use in operating room environments of hospitals and surgical centers. System setup may be performed by both clinical and trained non-clinical personnel.

The subject device records the following modalities:

• Somatosensory evoked potentials (SSEP)
• Motor evoked potentials (MEP),
• . Train-of-four neuromuscular junction (TO4),
• Triggered electromyography (tEMG) and ●
• . Free run electromyography (sEMG)

The provided text does not contain detailed information about specific acceptance criteria for the device's performance, nor does it describe a study that rigorously proves the device meets such criteria through a clinical validation or similar performance evaluation.

The document is a 510(k) premarket notification summary for the "SafeOp 3: Neural Informatix System." Its primary purpose is to demonstrate substantial equivalence to a previously cleared predicate device (SafeOp2: Neural Informatix System, K213849, and reference device Cascade IOMAX Intraoperative Monitor, K162199), rather than to present a full clinical performance study with defined acceptance criteria and detailed results.

Here's a breakdown of what the document does say, and what it lacks in relation to your request:

What the document provides:

• Device Name: SafeOp 3: Neural Informatix System
• Intended Use/Indications for Use: Monitoring neurological status by recording transcranial motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ) during various surgical procedures.
• Technological Comparison: A table comparing the SafeOp 3 System to predicate and reference devices, focusing on technical specifications like monitoring modalities, amplifier channels, stimulation parameters (voltage, current, pulse duration, repetition rate), and filter ranges. This comparison primarily aims to establish that the differences in technology do not raise new questions of safety or effectiveness.
• Performance Data (Non-clinical): Mentions that "Nonclinical performance testing demonstrates that the subject SafeOp 3 System meets the functional, system, and software requirements." It also states "EMC and Electrical Safety Testing... was performed to ensure all functions... are electrically safe, and comply with recognized electrical safety standards." Usability testing was also performed.
• Clinical Information Disclaimer: Explicitly states, "Determination of substantial equivalence is not based on an assessment of clinical performance data."

What the document lacks significantly for your request:

• A table of acceptance criteria and reported device performance: This is the most significant omission for your request. The document details technical specifications and comparisons but does not provide quantitative performance metrics (e.g., accuracy, sensitivity, specificity, or specific error rates) against pre-defined acceptance thresholds for any of its functionalities (MEP, SSEP, EMG, NMJ). The performance data mentioned are non-clinical (functional, system, software, EMC, electrical safety, usability), not clinical performance metrics.
• Sample size used for the test set and data provenance: Since specific clinical performance studies are not detailed, this information is not provided.
• Number of experts used to establish ground truth and qualifications: Not applicable as a clinical ground truth establishment process for performance evaluation is not described.
• Adjudication method for the test set: Not applicable.
• MRMC comparative effectiveness study: No such study is mentioned or detailed.
• Standalone (algorithm only) performance: While the device is an "algorithm only" in a sense (it processes physiological signals), its performance isn't quantified in a standalone clinical evaluation or comparative study.
• Type of ground truth used: No clinical ground truth is described for performance evaluation.
• Sample size for the training set: Not applicable, as this is related to AI/ML development and training, which is not described. The device is a neuromonitoring system, not explicitly stated to be an AI/ML device in the context of this submission.
• How the ground truth for the training set was established: Not applicable.

Why this information is missing:

The FDA 510(k) pathway for "substantial equivalence" often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate, without necessarily requiring new clinical trials or detailed performance studies if the technological differences are minor and well-understood. The focus is on showing that any differences do not introduce new safety or effectiveness concerns.

In summary, based solely on the provided text, I cannot complete the table of acceptance criteria or describe a study that proves the device meets these criteria in a clinical performance context. The document focuses on demonstrating substantial equivalence through technical comparison and non-clinical testing, rather than presenting clinical performance metrics.

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MEGA-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient's neurophysiological status.

The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways.

It is provided in three different configurations:

I. 32/B

II. 32/S

III. 16/S

The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potential), MEP (motor evoked potential), EEG (electroencephalography), AEP (auditory evoked potential), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed.

The system is not intended to measure vital signs. It records the data to be interpreted by the neuromonitoring specialist.

MEGA-IOM system is intended for use in adults age 18 years and older.

The MEGA-IOM system with Neuro-IOM.NET software is intended for intraoperative neurophysiological monitoring (IOM).

The system is intended for monitoring the functional integrity and/ or mapping of central and peripheral nervous system including motor and sensory pathways.

Soterix Medical is assuming manufacturing of the predicate product cleared in K190703. This 510(k) submission includes the same hardware cleared with the predicate device system (no changes) and an updated version of the software compared to the predicate device.

Below, a high-level summary of the changes from the predicate are provided:

Software: The primary changes in this 510(k) submission are related to the software. The changes are troubleshooting updates for greater usability such as user interfaces and bug fixes. Detailed descriptions of these software changes per version are provided below:

Version 1.1.52.7: Fixes related to the stimulation stop after a few hours, adding a stimuli limit for double train stimulation, allowing pulse duration (200 microseconds) entry, masking noise limitation per IEC 60601-2-40 (Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment), reporting correct status of multichannel operation, prevent skipping of traces, and check for incompatible stimulation parameter entry.

Version 1.1.52.8: Fixes related to facilitating quick turning off stimulation, real-time stimulus change control, scrolling in spectral setup window, constraining window within pattern printout to screen, ensuring modality window description is unchanged, incorrect Ch 17 display in emulation mode, video filters error during installation, ensuring all text is displayed within visibility area, incorrect auditory evoked potentials (EPs) average calculation in emulation mode.

Version 1.1.52.9: Fixes related to exam saved message, flexibility to change test template sequence, sleep mode prevention, rendering speed, interpulse interval display correction, allowing comments in the event window, automatic creation of user template, template list update, impedance measurement window rendering, parameter display correction in EMG trigger window and Group mode, ensuring non-disappearance of red line around patient's birth date, enabling stimulation via local menu in Scoliosis test template, frame switching error during video recording, displaying correct device status.

Version 1.1.53.7: Fixes related to addition of video clip creation button, accidental stimulation activation protection, display of preliminary train in double train mode, voltage and charge value display in stimulation panel, allowing repetitive stimulation in Double Train and Train+Pulse modes, option to view amplitude values up to 10 microA, option to select scales in X axis, option to delay auto saving if stimulation in progress, option to titrate stimulation amplitude using mouse wheel, option to select grid type, confirmation on layout uninstallation, addition of the Pause button in Stimulation programs, option to select motor response search interval and displaying the motor response search interval, addition of measured impedance visualization, offering first the windows already available when adding a new window, preventing closure of window if input row is active in derivation test, enable display of additional TOF parameters, option to playback trace fragments, addition of Take a screenshot command, parameter trend export, pulse duration interval display in TES train, option to enter multiple-line comments, option to re-name layout, option to hide command list, ability to save only responses beyond a certain level, stimulator list scrolling, RMS noise value display, test template cloning, motor response onset marker, previous recorded traces display, layouts during new test reset, stimulator reminder mod, video file duration based on frame rate, saving of the number of traces, test template rewriting, group trace visualization display, layout switching, stimulation resumption post coagulator off, video playback if another program is run.

Version 1.1.53.8: Fixes related to allowing multiple image view within the image window, allowing EEG artifact recording, showing baseline in the Overlay mode, option to disable program, option to save screen shots to a specific folder, stimulation program panel addition, correction of autoincrement window bug, correction of DSA rendering.

Version 1.1.53.9: Fixes related to custom scale adjustment in Freerun window, randomly changing pulse intervals in multichannel mode, event trace copy to report, layout panel updating post deletion, sound, threshold, and color parameter display during new site addition, EMG channels in template during long-term monitoring, site visibility during stimulation in presence of temporary markers, auto sweep resets, temporary markers display, trace export to EDF, layout non-save post video window opening, type conversion in trace window.

Version 1.53.10: Fixes related to video window copying over to report, trace scale reset, appearance of average trace display in case of no averages due to artifacts, site name display in TOF window, saving of initial study state in autosave mode, incomplete installation of video components, volume increment of auditory stimulator signal volume.

Version 1.1.53.11: Fixes related to active probe switch-off during monitoring, limiting maximum increment adjustment of electrical stimulation amplitude to 1 mA and 5V, stimulus duration set-up when stimulation amplitude is increased, stimulation disablement after power supply resume, stimulus sound notification, text visualization in dialogue box, non-active stimulator panel, maximum stimulus artifact width display, minimum and maximum MEP trace markers.

Version 1.1.53.12: Fixes related to pulse width change during stimulation in multichannel mode, MS Office word report, TeamViewer, logo, and translation corrections.

Version 1.1.53.13: Fixes related to removal of sites containing TOF and logo change.

Version 1.1.53.14: Fixes related to start monitoring during video camera switch off, video recording in some interface languages, sound disablement during impedance measurement, printing test template, USB driver-related Windows 10 OS bugs.

In summary, the aforementioned software changes are related to resolving software bugs and increasing user convenience, but the changes do not impact the intended use, indications for use statement, contraindications, or warnings. They also don't increase the likelihood that the device will be used by a broader or different group of users and do not raise any new risks.

Labeling: Modifications have been made to labeling and these changes are related to the new device trade name and change in manufacturer. Instances of "Neuro-IOM" were changed to "MEGA-IOM" in the user manual and on the device labels. Soterix Medical is named the manufacturer and point of contact in the labeling including for all complaints and service requests.

Waveforms: The MEGA-IOM system has the same waveforms as the predicate device. No change to the waveforms.

The provided text is a 510(k) Premarket Notification from the FDA for the "MEGA-IOM system with Neuro-IOM.NET software". This document primarily focuses on demonstrating substantial equivalence to a predicate device (K190703 Neuro-IOM system with Neuro-IOM.NET software) rather than detailing extensive clinical studies with acceptance criteria for new device performance.

The submission is for a device that has primarily undergone software updates and a change in manufacturer. Therefore, the "study that proves the device meets the acceptance criteria" is in the form of software verification and validation, and comparison to the predicate device's established performance.

Here's an analysis based on the provided text:

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

The document doesn't provide explicit "acceptance criteria" in the traditional sense of a clinical trial (e.g., target sensitivity/specificity for a diagnostic AI). Instead, the acceptance criteria are implicitly demonstrating that the updated software, in conjunction with the unchanged hardware, performs identically or equivalently to the predicate device. The performance is assessed by confirming that all functional and technical specifications remain the same.

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The product is used for intraoperative monitoring and testing during surgical procedures
· to examine neuronal tissue (central and peripheral nervous system) by recording and stimulation

The product can be used during surgical procedures that justify non-therapeutic clinical use of the following modalities or their combinations:

• · Measurement:
• o Auditory evoked potentials (AEP)
• o Electroencephalography (EEG)
• o Electrocorticography (ECoG)
• o Electromyography (EMG)
• o Somatosensory evoked potentials (SSEP)
• o Motor evoked potentials (MEP)
• o Train of Four (TOF)
• · Stimulation:
• o Transcranial electrical stimulation (TES)
• o Direct cortical and subcortical stimulation (DCS)
• o Direct nerve stimulation (DNS)
• o Transcutaneous intraoperative nerve stimulation (TINS)
• o Direct muscle stimulation (DMS)

The ISIS Headboxes and the ISIS Neurostimulator constitute multimodal intraoperative neuromonitoring systems called ISIS IOM Systems. These systems consist of custom stimulation and recording hardware, a standard laptop or desktop personal computer running an off-the-shelf operating system, and operating software called NeuroExplorer. As an option, these systems mount on device carriers or housings tailored for intraoperative use.

The ISIS IOM Systems support the following measurement modalities:

• -Auditory Evoked Potentials
• -Transcranial and cortical Motor Evoked Potentials
• Somatosensory Evoked Potentials -
• Free-running and triggered Electromyography -
• Electroencephalography -
• Train of Four -

The provided document is a 510(k) summary for the ISIS Headboxes and ISIS Neurostimulator, which are intraoperative neuromonitoring systems. It focuses on demonstrating substantial equivalence to a predicate device (K212166) rather than establishing novel acceptance criteria and proving performance against them in a clinical study.

The document states that no additional clinical testing was performed for the subject devices. Instead, the submission relies on bench testing against established standards and internal requirements to demonstrate safety, effectiveness, and performance that is "as well as or better than" the predicate device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a de novo AI/ML device (which often involves clinical performance metrics like sensitivity, specificity, etc.) are not directly applicable or available in this document.

Here's an attempt to extract the relevant information based on the provided text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission demonstrating substantial equivalence to a predicate device through bench testing rather than a de novo AI/ML device with pre-defined performance metrics, the acceptance criteria are primarily related to adherence to international standards and internal requirements for electrical safety, EMC, and software validation.

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

• Sample Size: Not applicable in the traditional sense of a clinical test set with patient data. The testing was primarily bench and software validation. The "sample size" would refer to the number of units tested, which is not specified, but implied to be sufficient for type testing.
• Data Provenance: The data refers to the results of internal bench tests and software validation activities, conducted by the manufacturer (inomed Medizintechnik GmbH) in Germany. It is entirely retrospective in the sense that it's performed on a developed product to meet predefined standards.

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

• This information is not provided because no clinical test set with expert-established ground truth was used. The ground truth for functional verification would be the expected output or behavior according to engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

• Not applicable as there was no clinical test set requiring expert adjudication.

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 MRMC comparative effectiveness study was done. The device is a neuromonitoring system, not an AI-assisted diagnostic or interpretive tool that would inherently involve "human readers" in that sense. The submission explicitly states: "No additional clinical testing was performed".

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

• The document implies that the "software validation" and "bench testing" constitutes a standalone performance evaluation of the device's functional integrity as an algorithm/system. The software (NeuroExplorer) and hardware components were tested to ensure they meet their predetermined specifications and comply with relevant standards independently of human interpretation of clinical outcomes. However, this is not an "AI algorithm only" type of standalone performance, but rather functional performance of medical device software/hardware.

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

• For the bench and software testing, the "ground truth" would be established by the engineering specifications, international performance standards (e.g., IEC 60601 series), and documented functional requirements of the device. This is a technical (rather than clinical/biological) ground truth.

8. The sample size for the training set

• This device is not described as an AI/ML device that requires a "training set" in the context of machine learning model development. Therefore, this question is not applicable. The software development follows a traditional software lifecycle process, not a machine learning training paradigm.

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

• Not applicable, as there is no mention of an AI/ML training set.

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The Guardian with Cascade Surgical Studio software is an electroneurodiagnostic device that acquires, displays, and stores physiologic data from peripheral sensory and motor nerves, muscles, and the central nervous system, generated either spontaneously or elicited by stimuli.

Guardian can perform somatosensory, auditory, and visual evoked potentials (EPs), electroencephalography (EEG), electrocorticography (ECoG), spontaneous and triggered electromyography (EMG), transcranial motor evoked potentials (TcMEP), direct cortical stimulation (DCS), direct nerve stimulation (TEMG, DNS), nerve conduction studies (NCS), and Train of Four (TOF) analysis.

Guardian can provide remote review outside of the operating room.

Guardian is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing.

The following functions are specifically supported individually or in combination:

Evoked Potentials (EPs): Guardian can provide electrical, auditory, and visual stimulation and measure, display, record, and store the electrical activity of the nervous system in response to the stimulations delivered.

Electroencephalography (EEG): Guardian can measure, display, record, and store electrical activity of the brain from two or more electrodes on the scalp.

Electrocorticography (ECoG): Guardian can measure, display, record, and store electrical activity directly from the brain using two or more electrodes.

Free Run Electromyography (EMG): Guardian can acquire, display, record, and store EMG activity of motor nerves.

Triggered Electromyography (TEMG): Guardian can electrically stimulate motor nerves, and display, record, and store the results.

Transcranial Motor Evoked Potentials (TcMEP): Guardian can deliver electrical transcranial stimulation, and display, record, and store the results.

Direct Cortical Stimulation (DCS): Guardian can deliver electrical stimulation to various areas of the cerebral cortex, and display, record, and store the results.

Direct Nerve Stimulation (DNS): Guardian can electrically stimulate cranial and peripheral nerves, and display, record, and store the results.

Nerve Conduction Study (NCS): Guardian can measure, display, record, and store sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system.

Train of Four (TOF): Guardian can deliver a train of four pulses, and measure, display, record, and store the results.

The Cadwell Guardian is a multi-modality intraoperative neurophysiological monitoring system with up to 80 channels of data acquisition.

The Guardian system is designed to be flexible and scalable depending on customer and procedural requirements. All systems require a Power Comm and Guardian Base, which contains an electrical Transcranial Stimulator. The user may select up to two Omni Amplifiers, two ES-10 electrical stimulators, one AVX auditory and visual stimulator, and one SMX-32 EEG amplifier that contains a low current electrical stimulator, in order to meet specific requirements.

The Guardian requires a (PC) with Windows operating system. The Guardian system uses a new version (4.0) of previously cleared Cadwell Cascade Surgical Studio software. Surgical Studio acquires, stores and reviews a wide range of intraoperative neurophysiological data, such as EMG, EEG, SSEP, BAEP, VEP, MEP and TOF, and includes Report Generation.

The provided text describes the Cadwell Guardian device, its indications for use, and a comparison to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria with quantitative performance metrics (like sensitivity, specificity, or accuracy) derived from a test set of data.

The document states:

• "Performance Testing: The Cadwell Guardian was tested in accordance with internal software requirements, system requirements, and usability requirements. Test results indicate that the Cadwell Guardian complies with its predetermined specifications."
• "Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the Cadwell Guardian. The results of these activities demonstrate that the Cadwell Guardian is as safe, as effective, and performs as well as the predicate devices. Therefore, the Cadwell Guardian is considered substantially equivalent to the predicate devices."

This indicates that internal performance testing was conducted, and the device met its specifications, leading to a determination of substantial equivalence to predicate devices. However, the details of these "predetermined specifications" or "internal software requirements" in terms of specific performance metrics are not provided in the given text. There's no mention of a clinical study or a study involving a "test set" of data for algorithm performance, human reader performance, or ground truth establishment in the way typically expected for AI/CADe device submissions.

Therefore, I cannot populate the requested tables and sections with quantitative data from the provided text. The document focuses on regulatory approval through substantial equivalence based on technical characteristics and safety standards rather than a detailed performance study against specific acceptance criteria for an AI component.

Summary of missing information based on the request:

1. Table of acceptance criteria and reported device performance: Not provided. The document states "complies with its predetermined specifications" but does not detail these specifications or measured performance.
2. Sample size used for the test set and data provenance: No information on a specific "test set" for performance evaluation, nor its size, origin (country), or whether it was retrospective/prospective.
3. Number of experts used to establish ground truth & qualifications: Not applicable, as there's no mention of a ground truth establishment process for a test set.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The approval is based on substantial equivalence to existing devices, not a comparative effectiveness study involving human readers with/without AI assistance.
6. Standalone (algorithm only) performance: Not mentioned, as the device is an electroneurodiagnostic system, not a standalone AI algorithm for interpretation.
7. Type of ground truth used: Not applicable, as no external ground truth establishment is described for performance evaluation.
8. Sample size for the training set: Not applicable, as the document doesn't describe an AI/ML component with a training set. The software is noted as "a new version (4.0) of previously cleared Cadwell Cascade Surgical Studio software."
9. How ground truth for the training set was established: Not applicable.

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The ATEC IOM Accessory Instruments are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

The ATEC IOM Accessory Instruments are surgical instruments that provide electrical stimulation to the body to locate and identify nerves in either open, minimally invasive, or percutaneous procedures. These surgical instruments are compatible with common FDA cleared neuromonitoring platforms as they are connected via a compatible clip or probe depending on the system. The neuromonitoring capability provides the surgeon with spinal nerve location, proximity, and integrity information. This information assists the surgeon during targeting, bone preparation, and placement of orthopedic implants such as intervertebral fusion devices (e.g., interbodies) and bone screws (e.g., pedicle screws). All sterile instruments are single use only and all reusable instruments are offered non-sterile to be steam sterilized by the end user.

The purpose of this submission is to gain clearance for new dilators made of conductive sliver ink, aluminum alloy, and dielectric coating.

The provided document is a 510(k) summary for the ATEC IOM Accessory Instruments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance testing. It does not describe an acceptance criteria and study proving device meets acceptance criteria in the context of clinical performance or accuracy of an AI/ML device.

Therefore, I cannot extract the specifically requested information regarding acceptance criteria and study details as they pertain to such a device type because this information is not present in the provided document.

The document discusses:

• Manufacturing and material equivalence: The new dilators are made of conductive silver ink, aluminum alloy, and dielectric coating and are compared to existing predicate devices.
• Performance testing (non-clinical): This includes electrical safety testing (IEC 60601-1), functional performance testing (insulation effectiveness and electrical resistance), and reprocessing validation. All samples passed acceptance criteria for these tests.
• Biocompatibility testing: Evaluated per ISO 10993-1 for cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity.

None of these tests involve "device performance" in terms of clinical accuracy, AI/ML output, or human-in-the-loop effectiveness.

However, I can extract the information that is present about the non-clinical performance testing:

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

2. Sample size used for the test set and the data provenance: Not applicable. The tests mentioned are laboratory-based electrical, functional, and reprocessing tests, not clinical studies with patients or data sets with provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are engineering and sterilization tests, not expert-adjudicated clinical assessments.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to clinical or image-based adjudication, not engineering tests.

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 accessory instrument, not an AI/ML diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an accessory instrument, not an AI/ML algorithm.

7. The type of ground truth used: Not applicable in the context of clinical accuracy or AI performance. For the engineering tests, "ground truth" would be the specifications and requirements of the applicable standards (e.g., IEC 60601-1, AAMI TIR30, ANSI/AAMI/ISO 17665-1).

8. The sample size for the training set: Not applicable. This device is not an AI/ML product.

9. How the ground truth for the training set was established: Not applicable. This device is not an AI/ML product.

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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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