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The NeuroField Analysis Suite is to be used by qualified clinical professionals for the display and storage of electrical activity of a patient's brain, including the post-hoc statistical evaluation of the human electroencephalogram (EEG) and event-related potentials (ERP).

The NeuroField Analysis Suite is a Normalizing Quantitative Electroencephalograph (QEEG) Software that can (1) execute EEG analysis and (2) conduct ERP test and ERP analysis. The NeuroField Analysis Suite is Software as a Medical Device (SaMD). The NeuroField Analysis Suite consists of two modules, the NF EEG Analysis Module and the NF ERP Module. The NF EEG Analysis Module is a separate analysis module that integrates with the Q21 EEG system by adding "Analysis", "Report", and "Tools" menu items and toolbars. It performs real-time and offline analysis functions and displays analysis results in separate windows in the UI, which can be accessed via the "Analysis" and "Reports" menu items. The NF ERP Module is a separate evoked response potential (ERP) module that can control and get data from the Q21 EEG system and performs typical ERP functions like stimulus presentation, EEG epoching, epoch averaging, reaction time, and ERP display. The NF ERP Module is a separate stand-alone application.

The NeuroField Analysis Suite, comprising the NF EEG Analysis Module and the NF ERP Module, was evaluated for performance. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA document doesn't explicitly state acceptance criteria in terms of numerical performance metrics (e.g., specific accuracy, sensitivity, specificity values). Instead, substantial equivalence is claimed based on comparable functionality and performance to predicate devices. The "performance" reported reflects this comparative approach.

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

• NF EEG Analysis Module: The document states that "Comparative performance evaluations showed that the same EDF file, loaded to NF-EEG and Neuroguide shows comparable signals on the EEG Plot." It also mentions "real and simulated data" for spectrum and sidelobe calculations. No specific sample size (number of EDF files or simulated data instances) is provided.
  • Data Provenance: Not explicitly stated, but the use of "real and simulated data" suggests a mix. "Same EDF file" implies existing data, which could be retrospective.
• NF ERP Module:
  • "Mathematical validation of NF-ERP was performed." - No specific sample size mentioned, as this is a theoretical assessment.
  • "Analysis of real data shows that the NF-ERP can elicit correct ERP components, the generated stimulus is reliable, and the split-half reliability measure confirms test reliability." - No specific sample size (number of cases/patients) is provided for this "real data" analysis.
  • Data Provenance: "Real data" is used, but country of origin or whether it's retrospective/prospective is not specified.

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

The document does not mention the use of experts to establish a "ground truth" for the comparative performance evaluations of either the EEG or ERP modules. The comparison is primarily against the output of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no external "ground truth" established by experts or adjudication process is described for the test set. The comparison is directly between the outputs of the NeuroField Analysis Suite and the predicate devices (Neuroguide or eVox).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers' improvement with AI vs. without AI assistance was not conducted or described in this document. The study focuses on the standalone performance and comparison to predicate devices, not human-in-the-loop performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, a standalone performance evaluation was done for both modules.

• NF EEG Analysis Module: Directly compared its outputs (EEG plots, spectrums, sidelobes, Z-scores, headmaps) against those of the Neuroguide Analysis System.
• NF ERP Module: Underwent mathematical validation to confirm the correctness of averaged ERPs and analysis of real data to demonstrate correct ERP component elicitation, stimulus reliability, and test reliability using split-half reliability.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations is implicitly the output or established functionality of the predicate devices (Neuroguide for EEG and eVox for ERP). For the NF ERP module, mathematical correctness and consistency with known physiological responses (correct ERP components, reliable stimulus) served as the "ground truth" for its internal validation. There's no mention of pathology, outcomes data, or external expert consensus as a ground truth.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set size. This suggests that the NeuroField Analysis Suite, as a QEEG and ERP analysis software, likely relies on established algorithms and mathematical models rather than machine learning models that require extensive training data.

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

Not applicable, as no training set or machine learning model is described. The device appears to be based on deterministic algorithms for signal processing and statistical evaluation of EEG/ERP data.

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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.

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.

1. Table of Acceptance Criteria and Reported Device Performance:

2. 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.

3. 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.

4. 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.

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 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.

6. 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.

7. 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.

8. 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.

9. How the ground truth for the training set was established:

   • Not applicable, as no training set was described.

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