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The eVox System is intended for the acquisition, display, and storage, of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis.

Device Description

The medical system includes the "eVox System" amplifier device, accessories, and a computer (laptop computer or tablet device with internal battery and power cord).

The hardware and ancillary components used in conjunction with the eVox System include an EEG cap, the eVox Amplifier, a charging kit (that consists of a USB cable, clip kit, and wall adapter), a Subject Response Device and a Base Station laptop computer. The software on the Base Station laptop computer is intended for device functioning.

The eVox System consists of two software components:
. Base Station laptop computer software: pre-loaded Evoke software EVO-002-400-BIATS.
. Firmware running on the eVox Amplifier PN SW-MSP430.

The Base Station laptop is running on a Windows Operating System and is paired with the eVox Amplifier with Bluetooth wireless technology. The Evoke software runs on the Base Station computer and has a graphic user interface that allows the clinician to set up a patient and create a new patient record, conduct a study to collect EEG and ERP data, view live EEG and ERP data on the Base Station monitor, and export recorded data to a file.

Firmware for the eVox System resides on the eVox Amplifier. The purpose of the eVox amplifier firmware is to acquire electrophysiology data from the patient and transmit it to the Base Station.

The Amplifier operational mode is controlled wirelessly via the Evoke software. In addition to 19 channels of EEG recording the device includes a mode to measure the cap electrode impedances. This is useful for determining if the electrodes are making a good electrical connection with the scalp at each electrode location.

The primary software outputs are EEG and ERP data files. These data files are written as floating point numbers in binary format, which represent the electrical potential on each of the 19 EEG channels in microvolts.

The eVox System amplifier device does not come in direct contact with patients. Accessories that contact patients, such as the EEG electrode cap, are the same as used with legally marketed devices or are comprised of the same materials as legally marketed accessories.

The eVox System is intended for prescription use in any healthcare, medical, or athletic or sports clinics, or outside of medical facilities such as in the sports arena under the supervision of a physician. Also, investigations can be performed outside of healthcare facilities, as long as they are led by qualified medical personnel.

The device is not sterile. The device is intended for use by qualified medical personnel only and qualifies for exemption per 21 CFR 801 Subpart D «Prescription devices».

AI/ML Overview

The eVox System is intended for the acquisition, display, and storage of electrical activity of a patient's brain, including electroencephalograph (EEG) and event-related potentials (ERP), obtained by placing two or more electrodes on the head to aid in diagnosis.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria (IEC 60601-2-26 Performance Limits)	Reported Device Performance (eVox System)	Met Criteria?
Accuracy of Signal Reproduction	Error < 20%	Pass: Accurately reproduces EEG signals over the specified range	Yes
Input Dynamic Range and Differential Offset Voltage	Amplitude error < 10% (at 300mV offset)	At 300mV Offset: 100% error (Fail); At 187mV Offset: 1.5% error (Pass)	Partially
Input Noise	Max 6 µV peak-to-valley	Maximum noise: 3.4 µV	Yes
Frequency Response	Output amplitude > 71%, < 110%	0.5 Hz: 100% (Pass); 5 Hz: 105% (Pass); 50 Hz: 76% (Pass)	Yes
Common Mode Rejection	Output amplitude < 10mm (= 100µVpp)	With 0 DC Offset: 67.3µVpp (Pass); With 187mV dc Offset: output is saturated (Fail)	Partially

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

The provided summary does not specify a sample size for a test set in terms of patient data or data provenance. The performance data section describes technical validation tests against established standards (IEC 60601-2-26), not clinical studies with patient data. These tests were conducted by accredited laboratories.

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

This information is not applicable as the provided performance data focuses on technical verification against international standards and not on clinical performance evaluated against a ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable as the performance data details technical compliance tests against pre-defined limits in standards, not clinical evaluations requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not indicated in the provided document. The submission focuses on demonstrating substantial equivalence through technical performance data and comparison to predicate devices, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The provided document describes the standalone performance of the eVox System in terms of its ability to acquire, display, and store EEG/ERP data and its compliance with relevant electrical and safety standards. The performance data presented (e.g., accuracy of signal reproduction, input noise) are measurements of the device's inherent technical capabilities, independent of human interpretation or intervention beyond basic operation. The device itself is an acquisition and display system, not an AI-driven diagnostic algorithm that would require a "human-in-the-loop" performance study in the same way an AI for image interpretation would.

7. Type of Ground Truth Used

The "ground truth" for the performance data presented is based on pre-defined technical specifications and limits set by international standards, specifically IEC 60601-2-26:2012 for electroencephalographs. For electrical safety and EMC, the ground truth is compliance with IEC 60601-1 and IEC 60601-1-2 standards.

8. Sample Size for the Training Set

The document does not mention a training set as this device is an EEG/ERP acquisition and display system. It does not appear to involve machine learning or AI algorithms that require a training set in the conventional sense for medical imaging or diagnostic interpretation.

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

Since there is no mention of a training set for machine learning or AI, the establishment of ground truth for a training set is not applicable.

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