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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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