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The general purpose of the proposed device is identical to the predicate device: "to perform the measurements needed for electromyography (EMG), nerve conduction velocity (NCV, F wave, and H reflex), and evoked potentials (brainstem, visual, and somatosensory), and repetitive nerve stimulation." The purpose of the proposed device is to allow compatibility with high-impedance electrodes. The design of the device provides inputs that can be made closer to the source of the signal for reduced signal noise during procedures requiring high-impedance electrodes.

Device Description

The proposed device consists of the existing four- /eight-channel preamplifier and a buffered electrode input box with extension cable. These components provide electrode inputs that are closer to the source of the signal during electromyographic (EMG) testing. The intent of this design is to reduce signal noise during procedures requiring high-impedance electrodes. The proposed device is for use with the Cadwell Excel (K880088A) EMG instrument.

All device components are reusable and supplied non-sterile. The extension cable with electrode input box is compatible with EtO sterilization guidelines for procedures requiring a sterile field. The input box is available with separate active and reference input connectors or a single phono jack connector.

The attached extension cable connects the input box to the preamplifier by way of a cable adapter. The existing preamplifier will be fitted with three pin DIN connectors to accept the cable adapter.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Acceptance Criteria and Device Performance

Criteria	Cadwell Excel with the existing four-/eight-channel preamplifier	Cadwell Excel with the proposed four-/eight-channel preamplifier and buffered input box	Reported Device Performance (Proposed Device)
Safety	Designed to comply with UL 2601-1, CSA C22.2 No. 601.1-M90, and IEC 601-1. Type BF.	Designed to comply with UL 2601-1, CSA C22.2 No. 601.1-M90, and IEC 601-1. Type BF.	Compliant (Implied by "Designed to comply with" and "patient auxiliary current is well below the regulatory limits set forth by IEC 601-1 for BF connections.")
Electrode inputs	20 buffered electrode inputs with built-in full montage selection or 5-pin DIN connector.	20 buffered electrode inputs with built-in full montage selection. One remote buffered electrode input with separate active and reference pin jack connectors or single phono jack connector. Preamplifier fitted with 3-pin DIN connector.	As designed (Functional modification, not a performance metric to be 'met' in the same way as noise or impedance)
Isolation mode rejection	> 110 dB.	> 110 dB.	Compliant (Implied that this specification is met, as no deviation is reported)
Sensitivities	2 micro V/div to 25 mV/div in 13 steps.	2 micro volts/div to 25 mV/div in 13 steps.	Compliant (Implied that this specification is met, as no deviation is reported)
Noise	0.6 micro volts RMS (3 micro V peak to peak) from 10 Hz to 2 kHz typical.	0.6 micro volts RMS (3 micro volts peak to peak) from 10 Hz to 2 kHz typical.	Compliant ("measured value of peak-to-peak noise is less than the allowed value")
Input impedance	> 10,000 Mohms	> 10,000 Mohms	Compliant ("input impedance is greater than 10 Mohms")
Impedance measurement	Built-in individual electrode impedance measurement, including ground.	Built-in individual electrode impedance measurement, including ground.	As designed (Functional similarity)
Calibration	Built-in calibration signal 10 micro V to 50 mV peak to peak, sine or square wave in 13 steps.	Built-in calibration signal 10 micro V to 50 mV peak to peak, sine or square wave in 13 steps.	As designed (Functional similarity)
Artifact suppression	Automatic or manual stimulus artifact suppression.	Automatic or manual stimulus artifact suppression.	As designed (Functional similarity)
Low-cut filters	2-pole filter. Selectable at 0.04, 0.1, 1, 3, 10, 30, 100, 500 Hz.	2-pole filter. Selectable at 0.04, 0.1, 1, 3, 10, 30, 100, 500 Hz.	As designed (Functional similarity)
High-cut filters	Two-channel mode: 2 pole Butterworth--100, 200, 500 Hz; 1, 2, 3, 10, 20 kHz. Four- and eight-channel mode: 2 pole Butterworth--70, 100, 200, 500 Hz; 1, 2, 3, 10, 20 kHz.	Two-channel mode: 2 pole Butterworth--100, 200, 500 Hz; 1, 2, 3, 10, 20 kHz. Four- and eight-channel mode: 2 pole Butterworth--70, 100, 200, 500 Hz; 1, 2, 3, 10, 20 kHz.	As designed (Functional similarity)
Signal Morphology (Nerve Conduction Waveform)	N/A	N/A	Compliant ("does not distort the morphology of the nerve conduction waveform, nor does it significantly affect the onset time, peak time, or amplitude when compared to the signal that does not pass through the proposed device.")
Signal Morphology (EMG Waveform)	N/A	N/A	Compliant ("does not distort the morphology of the EMG waveform when compared to the signal that does not pass through the proposed device.")
Gain	N/A	N/A	Compliant ("gain is not affected by passing the signal through the proposed device.")
Patient Auxiliary Current	N/A	N/A	Compliant ("patient auxiliary current is well below the regulatory limits set forth by IEC 601-1 for BF connections.")

Study Details

The provided text details engineering and clinical tests performed to validate the proposed device.

Sample size used for the test set and the data provenance:
- Clinical Test 6 (Nerve Conduction Waveform): Not specified.
- Clinical Test 7 (EMG Waveform): Not specified.
- Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are referred to simply as "clinical tests."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. The clinical tests compare the proposed device's signal to the signal that "does not pass through the proposed device," implying a direct comparison without independent expert ground truth establishment in the traditional sense. The "clinical results" suggest expert assessment of waveform morphology, but the number and qualifications of those experts are not provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
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 electromyography (EMG) instrument component, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the device's performance was evaluated in an objective, standalone manner for metrics like gain, noise, input impedance, and patient auxiliary current. The clinical tests also assessed the device's impact on waveform morphology and timing without explicit human interpretation as the primary outcome, but rather the device's fidelity to the original signal.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For electrical/performance metrics (impedance, noise, gain, current): Engineering specifications and regulatory limits (e.g., IEC 601-1).
- For clinical waveform integrity (Nerve Conduction, EMG): Comparison against the signal "that does not pass through the proposed device." This implies the "ground truth" is the unadulterated signal captured by the existing system, and the device's performance is measured by its ability to faithfully reproduce or minimally alter that signal.
The sample size for the training set: Not applicable. This is a hardware modification for an EMG instrument, not a machine learning or AI model that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this device.

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