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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 NicoletOne EEGPSG software performs recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various neurological disorders and sleep related respiratory disorders. It is intended to monitor the state of the brain by recording and displaying EEG signals and can receive and display a variety of third party signals such as ECG, EMG, Oxygen Saturation or Respiration for patients of all ages.

NicoletOne software allows:

· Automated analysis of physiological signals that is intended for use only in adults.

· An optional Audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.

· Sleep report templates are provided which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values.

This device does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.

The NicoletOne application is a software product for digital electroencephalography, long term monitoring in Epilepsy, intensive care unit (ICU) monitoring, and polysomnography that runs on a panel PC, desktop or laptop computer. It is a Windows based application used by trained medical professionals to investigate brain function and sleep disorders.

The NicoletOne application collects and displays continuous physiological waveform data (via a Natus digital amplifier), and digital audio/video (via standard audio/video equipment). After collecting and saving the signals, it provides tools and analyze the signals, which aid in the interpretation of an EEG or PSG study. The software consists of four main functional areas:

• Data Acquisition & Display Real time collection of EEG. PSG and other physiological ● parameters. The data is stored and displayed in real time by the NicoletOne software on the acquisition computer and made available for subsequent review by a trained medical professional.
• Scoring/Review & Analysis The NicoletOne software application has features that facilitate ● study navigation, event marking, scoring, review of synchronized digital video, and data trends required by medical professionals in order to properly analyze and interpret the study data. In addition to allowing users to manually mark events for both electroencephalography (EEG) and polysomnography (PSG) studies the NicoletOne software also provides optional computer assisted event marking analyzers for certain events.
• Report Generation - Once the digital electroencephalography (EEG) or polysomnography (PSG) data has been acquired scored and reviewed by medical professionals the NicoletOne and NicVue software is used to generate a report of the study. The generated reports are associated with the patient in the patient database. NicoletOne also includes the ability to customize report templates to conform to individual facilities standards and policies.
• . Archiving & Data Management - Once the digital electroencephalography (EEG) or polysomnography (PSG) data has been acquired scored and reviewed by medical professionals the NicoletOne and Nic Vue software is used to generate a report of the study. The generated reports are associated with the patient in the patient database. NicoletOne also includes the ability to customize report templates to conform to individual facilities standards and policies.

Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the NicoletOne assisted-scoring analyzers were implicitly set as performance levels comparable to the manual markings of expert reviewers and clinical equivalence to the reference standard (majority rule), similar to results reported in literature and for other commercially available devices. The specific metrics used were Positive Percent Agreement (PPA) and False Detection Rate per hour (FD/h).

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: 49 PSG sleep studies for respiratory and limb movement events.
• Data Provenance: Retrospective. The patient data were collected from adult patients (32-85 years old) with a clinical indication for a sleep study, then de-identified and applied as subject data. The country of origin is not explicitly stated in the provided text.

3. Number of Experts and Qualifications

• Number of Experts: Three (3)
• Qualifications: "experienced and certified PSG specialists, including one board certified sleep specialist."

4. Adjudication Method for Test Set

The adjudication method was a majority rule (2+1). For respiratory events, a majority rule meant at least 2 out of 3 manual expert scorers agreed on the type of event(s) in an epoch or the absence of an event. For limb movement, it meant at least 2 out of 3 manual expert scorers agreed on the presence of the event type in the epoch.

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

No MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was mentioned. The study focused on the standalone performance of the AI algorithms compared to a reference standard established by human experts. The description states that the automated analysis is "intended for use only in adults" and that generated reports provide summaries, but clarifies that "This device does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners". The phrase "All automatic detection tools are provided as time saving aids to assist trained medical practitioners in the review and analysis of vast amounts of data. Each computer-assisted analyzer runs a specific type of event marking or numeric value processing in the study and each can be enabled individually as needed at the discretion of the user. The parameters used in the computer-assisted analyzers depend on available input signals in the study as well as user defined settings. All output from computer assisted analyzers require medical professional review and acceptance," further suggests that AI is intended for assistance rather than standalone diagnosis.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was conducted. The "NicoletOne assisted-scoring analyzers" were evaluated against the "Reference standard" (expert majority rule) on an epoch basis. The reported PPA and FD/h values are for the algorithm's performance without human-in-the-loop during the evaluation itself, although the system is intended for human review and acceptance in clinical use.

7. Type of Ground Truth Used

The ground truth used was expert consensus, specifically a majority rule (2 out of 3) of expert scorers who independently marked events of interest in each 30-second epoch based on AASM (American Academy of Sleep Medicine) criteria.

8. Sample Size for Training Set

The document does not specify the sample size for the training set used to develop the NicoletOne assisted-scoring analyzers. The studies described are for validation of the ready-to-use device.

9. How Ground Truth for Training Set Was Established

The document does not describe how the ground truth for the training set was established, as it focuses on the clinical validation study of the already developed device.

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The Natus VikingQuest 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 Potential (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 Natus VikingQuest 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 VikingQuest 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 Natus VikingQuest is intended to be used by a qualified healthcare provider.

The Natus VikingQuest 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 studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). VikingQuest provides a variety of tests spanning the various modalities. There are two configurations, portable and cart-based.

The provided text describes the 510(k) premarket notification for the Natus VikingQuest, a diagnostic electromyograph. The information focuses on its substantial equivalence to predicate devices and adherence to various medical device standards. However, it does not contain specific details about acceptance criteria, reported device performance in terms of clinical accuracy or effectiveness, sample sizes for test sets, data provenance, ground truth establishment, or clinical study designs (like MRMC or standalone performance).

The document primarily outlines the regulatory compliance, technological characteristics, and intended use of the device, rather than detailed clinical performance evaluations against specific acceptance criteria.

Therefore, for aspects related to acceptance criteria and a study proving device performance, the information is largely absent in the provided text.

Here's what can be extracted based on your request, highlighting the missing information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not specified in the provided text.
• Data Provenance: Not specified. The document describes engineering and regulatory compliance testing rather than clinical study data.

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

• Not applicable as no clinical test set or ground truth establishment by experts for performance against a diagnosis is described. The "ground truth" mentioned pertains to compliance with engineering and safety standards.

4. Adjudication method for the test set:

• Not applicable as no human adjudication of clinical results 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:

• No mention of an MRMC study or AI assistance. The Natus VikingQuest is a diagnostic electromyograph for acquiring, displaying, analyzing, and reporting electrophysiological information, not an AI-driven interpretation system.

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

• The document describes a medical device (electromyograph) for use by a qualified healthcare provider. It does not describe a standalone algorithm or AI performance. The performance verified is for the entire device as a system.

7. The type of ground truth used:

• For the regulatory and engineering tests (biocompatibility, software, electrical safety, EMC, usability), the "ground truth" is compliance with established international standards (ISO, IEC, AAMI/ANSI) and FDA guidance documents. There is no mention of pathology, expert consensus on clinical findings, or outcomes data in the context of the device's diagnostic accuracy proving.

8. The sample size for the training set:

• Not applicable. The document describes a medical device, not an AI/machine learning algorithm with distinct training and test sets in the typical sense. Software development was "rigorously verified and validated consistent with FDA guidance documents and standards," implying traditional software testing, not machine learning model training.

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

• Not applicable, for the same reasons as point 8.

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The Synergy Focus 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 Potential (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 Synergy Focus 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 Synergy Focus 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 Synergy Focus is intended to be used by a qualified healthcare provider.

The Natus Synergy Focus (Synergy Focus) 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 studies (NCS), needle electromyography (EMG) testing, evoked potential (EP) testing, and intra-operative monitoring (IOM). Synergy Focus provides a variety of tests spanning the various modalities.

The Synergy Focus consists of the following major components:

• Console base unit with integrated control panel;
• Amplifier (with three non-switched amplifier channels);
• Desktop or laptop computer with a keyboard and mouse;
• Display monitor; and
• Synergy Software.

The Synergy Focus optional accessories/components consists of the following:

• Stimulator probes (RS 10 probe, Stimulus Probe with controls)
• Footswitches (triple)
• LED goggles
• Headphones or other auditory transducers
• Patient response button
• Cart
• Isolation transformer
• Printer.

The Natus Synergy Focus is an electromyograph (EMG) device intended for the acquisition, display, analysis, reporting, and management of electrophysiological information from the human nervous and muscular systems.

Here's an analysis of its acceptance criteria and the study that proves its performance:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance relies heavily on demonstrating substantial equivalence to predicate devices (K112052 CareFusion Nicolet EDX with Viking Software and K120979 CareFusion Nicolet EDX with Synergy Software). Therefore, the "acceptance criteria" are primarily defined by the performance characteristics of these predicate devices, and the "reported device performance" demonstrates that the Synergy Focus either matches or improves upon these characteristics, or where there are differences, they do not raise new questions of safety or effectiveness.

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

The provided 510(k) summary does not explicitly state a sample size for a test set or data provenance in the context of clinical performance or AI/algorithm performance.

Instead, the submission relies on demonstrating substantial equivalence to its predicate devices (K112052 and K120979) through:

• Comparison of technical characteristics.
• Non-clinical performance testing (biocompatibility, software validation, electrical safety, EMC, and bench testing to applicable standards like IEC 60601-2-40).
• The explicitly stated conclusion that "Animal testing and clinical testing were not needed to demonstrate safety and effectiveness."

This indicates that there was no separate "test set" of patient data used for evaluating the performance of the Synergy Focus in a clinical or AI context, as its performance is considered equivalent due to identical or functionally equivalent hardware and software to already cleared devices.

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

Since no clinical or AI-specific test set was used requiring ground truth establishment by experts, this information is not applicable to this 510(k) submission.

4. Adjudication Method for the Test Set

As no test set involving human interpretation requiring adjudication was used, this information is not applicable.

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

An MRMC comparative effectiveness study was not done. The submission explicitly states that "Animal testing and clinical testing were not needed to demonstrate safety and effectiveness," and the device is a diagnostic electromyograph, not an AI-assisted diagnostic tool in the sense of image interpretation. Therefore, there is no AI assistance improvement effect size to report.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study focused on an algorithm's performance without human-in-the-loop was not done. The Synergy Focus is a hardware and software system for acquiring and displaying physiological signals, not a standalone algorithm providing diagnostic outputs. The software component, categorized as "MODERATE level of concern," underwent rigorous verification and validation during development, as noted in the "Software testing" section, but this is distinct from an AI algorithm's standalone performance study.

7. Type of Ground Truth Used

Given the nature of the device and the submission's focus on substantial equivalence through technical characteristics and non-clinical testing, there was no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of evaluating the diagnostic accuracy of a new algorithm or clinical performance. The ground truth (or reference standard) in this submission relates to:

• Engineering specifications and standards: The device's performance was compared against the technical specifications of the predicate devices and national/international standards (e.g., IEC 60601-2-40 for safety and performance of electromyographs).
• Predicate device characteristics: The primary "ground truth" for demonstrating substantial equivalence was the established safety and effectiveness of the Nicolet EDX with Viking and Synergy software systems.

8. Sample Size for the Training Set

Since there is no mention of an AI algorithm or machine learning component in this submission that would require training data, information regarding the sample size for a training set is not applicable. The software validation focused on standard software development lifecycle testing (verification and validation of pre-determined specifications), not on training a model.

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

As there was no training set for an AI algorithm, the question of how its ground truth was established is not applicable.

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