(412 days)
The qEEG-Pro System is to be used by qualified clinical professionals for the statistical evaluation of the human electroencephalogram (EEG).
qEEG Pro Database (QPD) 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 QPD 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, power asymmetry, and coherence for 19 monopolar and 171 selected bipolar derivations of the EEG. In all over 5,000 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.
Here's an analysis of the acceptance criteria and study detailed in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| qEEG-Pro produces results sufficiently in agreement with the predicate devices. | The study concludes that the subject device's output was "similar" to the predicate device's output. |
| The R-squared factor shall be 0.8 or better when comparing the subject device to the predicate device. | Explicit R-squared values are not provided in the text; however, the study concludes that the pre-defined acceptance criteria were met. This implies the R-squared of 0.8 or better was achieved. |
| The observed range of results obtained from the predicate devices shall be used to verify that the qEEG-Pro produces results in agreement with the results obtained from the predicate device. | The study states that computing values for a range of discrete ages and comparing them to the predicate device's output showed them to be "similar," thus verifying agreement with the predicate's observed range of results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 3 subjects (1 pediatric, 2 adult).
- Data Provenance: The text does not specify the country of origin of the data. It appears to be a prospective study as subjects' EEG recordings were specifically obtained for this validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The text does not explicitly mention any experts being used to establish the ground truth for the test set in the clinical study described. The validation appears to be a direct comparison of the qEEG-Pro's output against the predicate device, K041263, which itself contains a normative database. The "ground truth" in this context is essentially the established output and normative data of the predicate device.
4. Adjudication Method for the Test Set
The text does not describe any adjudication method like 2+1, 3+1, or similar. The validation focuses on comparing the numerical outputs (z-scores for absolute power) of the subject device (qEEG-Pro) against the predicate device (K041263).
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a technical validation comparing the output of the qEEG-Pro software to a predicate device, not a study involving human readers' performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone study was done. The clinical testing involved comparing the algorithm's output (qEEG-Pro) directly against the predicate device's algorithm output. The "Potential adverse effects" section also highlights the risks if qEEG-Pro is used "as a standalone diagnostic system in the absence of other clinical data from more traditional means of patient evaluation," indicating its standalone capability.
7. The Type of Ground Truth Used
The ground truth used in the clinical testing was the output of a legally marketed predicate device (NeuroGuide Analysis System (NAS), K041263). The comparison was based on z-scores for absolute power calculated for the same EEG data by both the subject and predicate devices.
8. The Sample Size for the Training Set
- qEEG-Pro Normative Database: 1482 samples (eyes-closed); 1231 subjects (eyes-open)
- Predicate Device (NAS) Normative Database: 625 samples
The text specifies these as the sample sizes for the normative databases used by the devices, which serve as their internal "training" or reference data for comparison.
9. How the Ground Truth for the Training Set was Established
The ground truth for the training sets (normative databases) for both the qEEG-Pro and the predicate device was established via "carefully constructed and statistically controlled age-regressed, normative database". These databases contain reference means and standard deviations for representative samples of EEG data. The variables in these databases have been "transformed and validated for their Gaussian distribution." This implies a process of collecting EEG data from a large, healthy population across various age ranges, processing it, and statistically characterizing it to form a reference against which individual patient EEGs are compared to generate z-scores.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).