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The NeuroField Q21 System is indicated for prescription use to acquire, record, transmit, and display physiological data for electroencephalographic (EEG) studies of patients of all ages.

Device Description

The Q21 is a 20-Channel Quantitative Electroencephalogram (QEEG) system which records 24-bit high resolution EEG data. NeuroField EEG is the main software which runs on a Windows-based computer/laptop where basic data is collected and controls the Q21. This software records the patient information and displays and stores the EEG. The Q21 system provides for typical EEG functions, including realtime EEG recording and viewing, adjustable vertical and horizontal display scale, adjustable highpass, lowpass, and notch filters, file import and export, offline review, the ability to show and hide individual channels, remontaging, and the ability to add event markers. The Q21 system supports both individual electrodes and standard 19-channel Electrocap electrode arrays. Each Q21 system consists of an amplifier, software, and components of a standard personal computer (monitor, keyboard, and mouse). The Q21 amplifier is a 19+1 channel, 24-bit, low-noise, non-multiplexed, battery-powered, optically-isolated amplifier. The "+1" channel can be used as an auxiliary physiological channel.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

Feature/Parameter	Acceptance Criteria (Predicate: Cadwell Apollo System, K201819)	Reported Device Performance (NeuroField Q21)
Regulatory Parameters
Indications for Use	Prescription use for EEG and PSG studies, all ages	Prescription use for EEG studies, all ages
Intended Population	Patients of all ages	Patients of all ages
Common/Usual Name	EEG	EEG
Regulatory Class	Class II	Class II
Classification Name/Product Code	882.1400 Electroencephalograph, GWQ	882.1400 Electroencephalograph, GWQ
Software Features
Realtime EEG recording/viewing	Yes	Yes
Adjustable display scale	Yes	Yes
Adjustable filters	Yes (highpass, lowpass, notch)	Yes (highpass, lowpass, notch)
File import/offline review	Yes	Yes
File export/sharing	Yes (EDF)	Yes (EDF, XDF)
Show/Hide individual channels	Yes	Yes
Remontaging	Yes	Yes
Ability to add event markers	Yes	Yes
Video recording	Yes	No
Hardware Features
Maximum number of channels	32	20
Individual electrode support	Yes	Yes
Electrocap support	Yes	Yes
Input dynamic range	> ± 300 mV	± 375 mV
A/D resolution	16 bit	24 bit
Sampling rate	Up to 2300 Hz	256 Hz
Notch filter	50 Hz and 60 Hz	50 Hz and 60 Hz
Input impedance	20 GΩ	>1000 GΩ
CMRR	>110dB	>110dB
Noise level	2500 V	>2500 V
Digital interface	Ethernet	CANBus
Power supply	Li-Ion Battery	Li-Ion Battery
Non-Clinical Performance Standards	Compliance with specific standards	Compliance with specific standards
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text)	Yes	Yes
- IEC 60601-1-2:2014+A1:2020	Yes	Yes
- IEC 80601-2-26:2019	Yes	Yes
Software Verification & Validation	Follow FDA guidance for "moderate" level of concern	Follow FDA guidance for "moderate" level of concern

Sample Size used for the test set and the data provenance:
- The provided document does not specify a test set sample size for "performance" testing in the traditional sense of a clinical or retrospective data study.
- Instead, the "testing" for this device focuses on demonstrating substantial equivalence to a predicate device based on features and compliance with non-clinical performance standards. There is no indication of a dataset of patient EEG recordings being used as a test set for performance evaluation.
- Data Provenance: Not applicable as no specific test set data (e.g., patient EEG recordings) was described for performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe a study involving expert-established ground truth for a test set of EEG recordings. The evaluation is based on technical specifications and compliance with recognized standards compared to predicate devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no test set requiring ground truth adjudication by experts for performance evaluation.
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 comparative effectiveness study was done. The device is an Electroencephalograph (EEG) system for acquiring, recording, transmitting, and displaying physiological data, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device itself is an EEG system; it is not an algorithm designed for standalone performance analysis described in the context of diagnostic interpretation. Its "performance" refers to its ability to accurately acquire and display EEG signals.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For this type of device (an EEG system), the "ground truth" for proving its functionality typically involves calibrated input signals and adherence to industry standards for electrical performance, rather than clinical ground truth like pathology or expert consensus on disease. The document states the device meets the requirements of specific external standards and underwent software verification and validation testing, which serve as the basis for demonstrating its functional performance.
The sample size for the training set:
- Not applicable. The document does not describe a training set in the context of machine learning or AI. The EEG system itself is a data acquisition and display device, not an AI model that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as no training set was described.

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