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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 CareFusion 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 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 Nicolet EDX with Synergy 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 Synergy 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 Synergy Software is intended to be used by a qualified healthcare provider.

The CareFusion Nicolet EDX system with Synergy Software (Synergy EDX) 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 EDX provides a variety of tests spanning the various modalities.

The Synergy EDX consists of the following major components:

• Nicolet EDX console base unit;
• Synergy control panel:
• Nicolet amplifier (there are two types available: 2 channel (AT2) with two non-switched amplifier channels and an 8 channel (AT2 + 6) amplifier with two non-switched and six switched amplifier channels;
• Desktop or laptop computer with a keyboard and mouse;
• Display monitor; and
• Synergy Software

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

• Nicolet HB6 or HB7 Head Box
• Stimulator probes (RS 10 probe, WR 50 Probe, S403 probe)
• SP1/SP2 electrical stimulator switching units
• Footswitches (single and triple)
• LED goggles
• Patient response button
• Photic strobe
• Headphones or other auditory transducers
• Cart
• Isolation transformer
• Printer

This document is a 510(k) Summary for the CareFusion Nicolet EDX with Synergy Software. It primarily serves to demonstrate substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with detailed acceptance criteria and results from a clinical trial or a structured validation study as one might expect for a novel AI/ML device.

Here's an analysis based on the provided text, addressing your points:

The Device: The CareFusion Nicolet EDX with Synergy Software is a diagnostic electromyograph system designed for acquiring, displaying, analyzing, reporting, and managing electrophysiological information from human nervous and muscular systems. It performs nerve conduction studies (NCS), needle electromyography (EMG), evoked potential (EP) testing, and intra-operative monitoring (IOM).

Overview of Acceptance Criteria and Performance (Based on Substantial Equivalence):

This submission is a 510(k) for substantial equivalence, not a new de novo device with specific clinical performance acceptance criteria against a ground truth. The acceptance criteria essentially revolve around demonstrating that the new device has the same technological characteristics, indications for use, and safety/effectiveness as its predicate devices, or that any differences do not raise new questions of safety or effectiveness.

The document primarily shows that the CareFusion Nicolet EDX with Synergy Software is "Identical" or "Similar" to its predicate device, the CareFusion Nicolet EDX with Viking software (K112052), with one minor addition (CNV test to EP modality) and one minor difference in auditory tone frequency that doesn't change indications for use or safety/effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission relying on comparison to a predicate, the "acceptance criteria" are implied by the similarity to the predicate, and "performance" is demonstrated by showing these similarities through technical specifications, rather than new quantitative performance metrics.

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The CareFusion 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 Potential (EP) includes Visual Evoked Potentials (VEP), Auditory Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP), Electroretinography (ERG), Electrooculography (EOG), P300, Motor Evoked Potentials (MEP). The Nicolet EDX with Viking 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 Viking 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 Viking Software is intended to be used by a qualified healthcare provider.

The CareFusion Nicolet EDX system with Viking Software (Viking EDX) 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). The system can also perform multi-modality recording through Multi-mode programs (MMP). Viking EDX provides a variety of tests spanning the various modalities.

The Viking EDX consists of the following major components:

• Nicolet EDX console base unit;
• Viking control panel;
• Nicolet amplifier (there are two types available: 2 channel (AT2) with two non-switched amplifier channels and an 8 channel (AT2 + 6) amplifier with two non-switched and six switched amplifier channels;
• Desktop or laptop computer with a keyboard and mouse;
• Display monitor; and
• Viking Software.

The Viking EDX optional accessories/components consists of the following:

• Nicolet HB6 or HB7 Head Box
• Stimulator probes (RS 10 probe, WR 50 Probe, S403 probe)
• SP1/SP2 electrical stimulator switching units
• Footswitches (single and triple)
• LED goggles
• Patient response button
• Photic strobe
• Headphones or other auditory transducers
• Cart
• Isolation transformer
• Printer

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not contain a discrete list of "acceptance criteria" for the device's overall performance. Instead, it details the device's technical characteristics and claims substantial equivalence to predicate devices based on these characteristics and compliance with various recognized standards. The "reported device performance" is primarily indicated by successful completion of these compliance tests.

However, based on the comparative tables (pages 11, 12, 13) and the performance testing section (page 17), we can infer performance characteristics that are likely considered "met standards" or "acceptable." I will present the new device's (CareFusion Nicolet EDX System) performance characteristics in a table, as these are the "reported performance" that met the criteria for substantial equivalence, which implicitly means they met acceptance criteria (i.e., met or exceeded predicate device performance and regulatory standards).

CareFusion Nicolet EDX with Viking Software - Reported Device Performance against Implied Acceptance Criteria (via Predicate Comparison and Standards Compliance)

The study that proves the device meets (or exceeds) these acceptance criteria is detailed in the "Summary of Non-Clinical Performance Testing Conducted for the Determination of Substantial Equivalence" section on page 17.

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

• Sample Size: The document does not specify a "sample size" in terms of patient data for the performance testing. The performance testing section (page 17) refers to "bench testing" and compliance with standards.
• Data Provenance: The document explicitly states: "Animal testing and clinical testing were not needed to demonstrate safety and effectiveness." (page 17). Therefore, there is no patient data provenance (country of origin, retrospective/prospective). The evidence relies on bench testing and comparisons to predicate devices, which are presumably based on established performance specifications and regulatory standards.

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

• Not applicable. As stated, animal and clinical testing were not performed. The "ground truth" for the device's technical performance was established by compliance with recognized engineering and safety standards (e.g., IEC, UL, ISO) and by demonstrating substantial equivalence to predicate devices. This implies that the technical specifications of the device met the established benchmarks of these standards and predicate devices, which were themselves cleared based on clinical utility and safety, likely informed by expert consensus in the field of electrophysiology. However, no specific "experts" were used to establish ground truth for a test set in this submission's performance evaluation.

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

• Not applicable. There was no clinical test set or human-in-the-loop experiment that would require an adjudication method by experts. The assessment was based on non-clinical performance (bench testing) and comparison to predicate devices against established standards.

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 diagnostic electromyograph and evoked potential system, not an AI-powered diagnostic tool requiring human-reader interpretation improvement studies. It is a hardware and software system for acquiring, displaying, and analyzing electrophysiological signals. The term "AI assistance" is not relevant to this device's stated functionality or evaluation.

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

• Yes, in a way. The performance testing described (biocompatibility, software testing, electrical safety, EMC, and bench performance testing) is essentially "standalone" testing of the device's components and system against predetermined specifications and international standards, without human interaction as part of the evaluation process, other than operators performing the tests. This confirms the inherent functional capabilities of the device itself.

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

• The ground truth used was primarily established technical specifications and international regulatory standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, UL 60601-1, ISO 10993-1) as well as the technical characteristics of legally marketed predicate devices. The device was deemed substantially equivalent because its performance met or exceeded these established benchmarks.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning product that requires a "training set" of data in the conventional sense. The "training" of the device refers to its design and development to meet functional requirements and standards, not a data-driven learning process.

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

• Not applicable, as there is no training set. The "ground truth" for the device's fundamental design and functionality was established by recognized engineering principles and adherence to medical device safety and performance standards.

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