(166 days)
EZTrack is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects with focal or multifocal epilepsy at least 3 years of age for the visualization of human brain from analysis of electroencephalographic (EEG) signals produced by electrically active tissue of the brain. EZTrack calculates and displays the Fragility Index, a quantitative index based on an analysis of spatiotemporal EEG patterns that is intended for interpretation by trained physicians to aid in the evaluation of patients with focal or multifocal epilepsy.
The device does not provide any diagnostic conclusion about the patient's condition to the user and should be interpreted along with other clinical data, including the original EEG, medical imaging, and other standard neurological and neuropsychological assessments.
EZTrack is a web-based software-only device that allows visualization of human brain function based on the analysis of electroencephalographic (EEG) signals. The EZTrack algorithm produces a fragility score for each EEG recording node. The EZTrack fragility values are shown to correlate with regions that clinicians have annotated as seizure onset zones (SOZ) prior to resective surgery, and may be used in conjunction with other clinical data such as EEG, medial imaging, neuropsychological testing, and other neurologic assessments in order to aid in the evaluation of patients with focal or multifocal epilepsy. The device does not provide any diagnostic conclusion about the patient's condition. EZtrack displays the fragility of each EEG channel in a heatmap to aid in interpretation.
Here's a breakdown of the acceptance criteria and study information for the EZTrack device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state acceptance criteria in terms of specific performance thresholds (e.g., sensitivity, specificity, AUC). Instead, the performance is described in terms of a statistically significant correlation and an effect size.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Fragility data correlates with clinically annotated Seizure Onset Zone (SOZ) and differentiates treatment success from failure. | EZTrack demonstrated a statistically significant difference (p-value=0.02) between the successful and failed Confidence Statistic distributions. An average effect size difference between the two groups of 0.627 was observed, meaning fragility had a 0.627 higher standardized confidence in the clinically annotated SOZ in successful outcomes compared to failed outcomes. |
| Software meets verification and validation requirements. | Software verification and validation testing were conducted and documentation provided as recommended by FDA guidance. The software was considered a Moderate Level of Concern. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 91 patients (comprising 462 seizures).
- 44 patients had successful outcomes (seizure-free).
- 47 patients had failed outcomes (seizure recurrence).
- Data Provenance: Retrospective study. The country of origin is not explicitly stated in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated, but it mentions "clinicians" and "Consensus agreement of the spatial distribution of visual EEG signatures together with pre-implantation data were used to construct the clinically annotated SOZ." This implies multiple clinicians were involved in a consensus process.
- Qualifications of Experts: The text refers to "clinicians" attempting to identify visual EEG signatures to isolate the SOZ during invasive monitoring. It also mentions "trained physicians" who would interpret the Fragility Index. Without further detail, it's difficult to specify exact qualifications (e.g., "Radiologist with 10 years of experience"), but they are clearly medical professionals with expertise in EEG and epilepsy.
4. Adjudication Method for the Test Set
The adjudication method for establishing the clinically annotated SOZ appears to be based on clinician consensus using "visual EEG signatures (e.g. HFOs, spikes, or burst activity) together with pre-implantation data." The text does not specify a numerical adjudication method like "2+1" or "3+1."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided text. The study focused on the EZTrack algorithm's correlation with SOZ and outcome, not on how human readers perform with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was conducted. The clinical study described is a retrospective study that demonstrates the EZTrack algorithm's output (fragility data) correlates with the clinically annotated Seizure Onset Zone (SOZ) and differentiates between successful and failed patient outcomes. The text explicitly states, "EZTrack demonstrated a statistically significant difference (p-value=0.02) between the successful and failed Confidence Statistic distributions, and an average effect size difference between the two groups of 0.627." This is a direct measurement of the algorithm's performance without human intervention in the analysis.
7. Type of Ground Truth Used
The ground truth used was expert consensus / clinical outcome data.
- Clinically annotated SOZ: Established by "clinicians" via "consensus agreement of the spatial distribution of visual EEG signatures together with pre-implantation data." This implies a form of expert consensus derived from clinical evaluation.
- Patient Outcome: Categorized as "seizure free (success), or having seizure recurrence (failure) at their 6-12 months post-op evaluations." This is objective outcomes data used to assess the clinical relevance of the SOZ identification.
8. Sample Size for the Training Set
The document does not provide information regarding the sample size used for the training set. The clinical study described is a retrospective study used for performance evaluation, not necessarily for training the algorithm.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any potential training set was established. The clinical study described focuses on evaluating the device's performance against established clinical SOZ and patient outcomes.
§ 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).