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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.

Summary of the "Study" (Demonstration of Substantial Equivalence):

The "study" here is not a typical clinical trial or performance study with a test set of data and ground truth as one would conduct for an AI/ML device. Instead, it's a demonstration of substantial equivalence to previously cleared devices (predicates) through:

• Comparison of Indications for Use: Showing they are the same or have minor, non-critical differences.
• Comparison of Device Description and Technological Characteristics: Detailing hardware components, software approach, electrical characteristics, and application modules, and highlighting that they are identical or very similar to the predicate.
• Non-Clinical Performance Testing:
  • Biocompatibility: Compliance with ISO 10993-1:2009.
  • Software testing: Designed and developed according to robust software development process (FDA guidance documents cited). Test results demonstrated compliance with predetermined specifications.
  • Electrical Safety & EMC Testing: Compliance with IEC 60601-1, UL 60601-1, and IEC 60601-1-2.
  • Performance Testing - Bench: Compliance with IEC 60601-2-40 (for electromyographs and evoked response equipment).

Specific Answers to Your Questions:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This type of information is not applicable or provided in this 510(k) summary. The submission does not describe a performance study with a "test set" of patient data or clinical images/signals. The testing reported is primarily bench testing, software verification/validation against specifications, and safety/EMC compliance. No clinical data (retrospective or prospective) from patient populations is mentioned for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. There was no "test set" of clinical data requiring expert review for ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set data was adjudicated.

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 study was done. This device is a diagnostic instrument, not an AI-powered assistive diagnosis tool in the sense that would require an MRMC study to show improvement in human reader performance. Its function is to acquire, display, and analyze electrophysiological signals, not to provide an AI-driven interpretation or assisted read.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable in the typical AI sense. The device's "performance" is its ability to accurately acquire, process, and display biological signals according to its technical specifications, and to function safely and effectively as an electromyograph. Its performance was assessed through engineering bench testing against established standards, not through an algorithm-only standalone performance evaluation against a "ground truth" derived from patient data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the technical characteristics and safety/EMC, the "ground truth" is adherence to engineering specifications, international safety standards (IEC, UL), and FDA guidance for software development. For biocompatibility, it's compliance with ISO 10993-1. These are widely accepted objective standards and specifications for medical device manufacturing and performance. There is no biological "ground truth" (e.g., pathology, expert diagnosis) used in this submission to establish device accuracy for a diagnostic claim, as the device itself is the measurement tool, comparable to a thermometer or blood pressure cuff.

8. The sample size for the training set:
Not applicable. This document describes a diagnostic device, not an AI/ML system that undergoes a "training" phase with a dataset.

9. How the ground truth for the training set was established:
Not applicable. No training set was used.

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