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The BrainView QEEG Software Package is to be used by qualified medical or clinical professionals for the statistical evaluation of the human electroencephalogram (EEG).

BrainView QEEG Software Package is a software program for the post-hoc statistical analysis of the human electroencephalogram (EEG). EEG recorded on a separate device (i.e., the host system) is transferred to the BrainView QEEG software package for display and user-review. The device herein described consists of a set of tables that represent the reference means and standard deviations for representative samples. These tables are implemented as computer files that provide access to the exact tabular data resource for use by software that uses the tables as an information resource. The system requires that the user select reliable samples of artifact-free, eyes-closed or eyes open, resting digital EEG for purposes of analysis. Analysis consists of the Fast-Fourier Transformation (FFT) of the data to extract the spectral power for each of the designated frequency bands (e.g. delta, theta, alpha, and beta), and frequency information from the EEG. The results of this analysis are then displayed in statistical tables and topographical brain maps of absolute and relative power asymmetry, and coherence for 19 monopolar and 171 selected bipolar derivations of the EEG. In all over 4,000 measures are derived for comparison against carefully constructed and statistically controlled age-regressed, normative database in which the variables have been transformed and validated for their Gaussian distribution. Each variable extracted by the analysis is compared to the database using parametric statistical procedures that express the differences between the patient and an appropriate age-matched reference group in the form of z-scores.

Acceptance Criteria and Study for BrainView QEEG Software Package

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "small" sample size of "selected subjects." The text specifies that 10-minute EEG recordings for eyes closed and eyes open were used. Although the initial sample size was small, it was used to derive 23 age-grouped sets of Z-scores for each subject, covering ages 4 to 85.
• Data Provenance: The data used for clinical testing consisted of "clinically acquired EEG waveforms." The document does not explicitly state the country of origin but implies it was collected in a clinical setting. It is retrospective as the data was "clinically acquired" and then used to validate the device's performance against a predicate.

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

The document does not explicitly mention the number or qualifications of experts used to establish a separate "ground truth" for the clinical test set. The validation was a direct comparison to the predicate device's output, implying the predicate itself served as a de facto reference. The "qualified medical or clinical professionals" are mentioned in the context of the device's intended use and not specifically to establish ground truth for this validation.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The comparison was primarily a quantitative analysis of Z-scores against the predicate device's output.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the agreement between the subject device and a predicate device, not on human reader performance with and without AI assistance.

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

Yes, the clinical testing described is a standalone (algorithm only) performance study. The BrainView QEEG software's output (Z-scores for absolute power) was directly compared to the output of the predicate device. The text explicitly states that the "BrainView QEEG software package is used as a standalone diagnostic system in the absence of other clinical data" (though this is also mentioned as a potential misuse scenario, it confirms its standalone operational capability).

7. The Type of Ground Truth Used

The ground truth for the clinical test set was effectively the output of the legally marketed predicate device (NeuroGuide Analysis System K041263). The study's acceptance criteria were based on agreement with this predicate device's results.

8. The Sample Size for the Training Set

The training set for the BrainView QEEG software's normative database consisted of:

• 2303 subjects for eyes closed EEG data.
• 1965 subjects for eyes open EEG data.

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

The ground truth for the training set (normative database) was established through "carefully constructed and statistically controlled age-regressed, normative database in which the variables have been transformed and validated for their Gaussian distribution." This implies the data was collected from a large, healthy population across a wide age range (4-85 years) and processed to establish statistical norms ("reference means and standard deviations"). While not explicitly detailing every step of "ground truth" establishment, this points to a robust statistical methodology based on data from a large population.

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