(147 days)
The QP-160AK EEG Trend Program is a software-only device intended to calculate and display EEG data obtained from the Nihon Kohden specified host device. The QP-160AK is intended to be used by qualified medical practitioners, trained in electroencephalography, who will exercise professional judgment when using the information. The intended use is as follows:
· The EEG and aEEG waveforms are intended to help the user monitor the state of the brain.
· The user-defined Fast Fourier Transform (FFT) parameters of this software (FFT power) are intended to help the user analyze the EEG waveform.
• The burst suppression parameters of this software (interval and bursts per minute) are intended to aid in the identification and characterization of areas of burst-suppression pattern in the EEG.
• The seizure detection component of QP-160AK is intended to mark previously acquired EEG waveforms of adult (greater than or equal to 18 years) that may correspond to electrographic seizures in order to aid in identification of seizure events and help review and annotation of EEG traces by user. EEG should be recorded with full scalp montage at the standard 10/20 system. The notifications for seizure detection are provided. QP-160AK notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
This device does not provide any diagnostic conclusion about the patient's condition to the user.
The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.
The QP-160AK EEG Trend Program is a software-only device. When installed in Nihon Kohden neurology products with EEG measurement function, the device calculates and displays EEG data obtained from the neurology product's system. In addition, the QP-160AK EEG Trend Program identifies trends in the EEG data over extended periods of time in order for trained healthcare professionals to observe changes over time.
The program's existing main features are listed below:
- Calculate and display aEEG, DSA, FFT and burst suppression ratio trend .
- Display up to 64 channel EEG ●
- . Display SpO2 and ETCO2 trends
- Operation by touch panel buttons
- . Data management with Neuro Workbench software
The modification is to add:
- Seizure detection and notification .
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Nihon Kohden QP-160AK EEG Trend Program
Specific New Feature Tested: Seizure detection component.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the seizure detection component are implicitly defined by the reported performance statistics in comparison to the predicate device or generally accepted clinical utility. While explicit pass/fail thresholds are not given for Nihon Kohden QP-160AK, the comparison to "a similar level of performance" to the predicate, Persyst 12, is key.
| Performance Statistics | Acceptance Criteria (Implicit, based on predicate performance context) | Reported Device Performance (Nihon Kohden QP-160AK Seizure Detection) |
|---|---|---|
| Positive Percent Agreement (PPA) | Expected to be clinically useful and comparable to predicate. | Mean: 77.2% (95% CI: 69.0 - 83.5%) |
| False Detection Rate (FDR) (False Positives/hr) | Expected to be clinically useful and comparable to predicate. | Mean: 0.451 (95% CI: 0.320 - 0.669) |
The provided graphs (Figures 0 and 3 on page 9) visually compare the QP-160AK's PPA and FDR to several other devices, including its predicate (Persyst12). This comparison serves as evidence for the "substantially equivalent" claim, suggesting that the QP-160AK's performance falls within an acceptable range relative to legally marketed predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 139 patients.
- Data Provenance: Archived EEG recordings from patients (18 years and older) admitted to an Epilepsy Monitoring Unit. The country of origin is not explicitly stated in the provided text. The data is retrospective, being "archived EEG recordings."
- Total EEG Recording Time: 556 hours (139 recordings * approximately 4 hours per recording).
- Total Seizures Identified: 145
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Three independent EEG experts.
- Qualifications: "EEG experts" – no further specific qualifications (e.g., years of experience, board certification) are provided in the text.
4. Adjudication Method for the Test Set
- Adjudication Method: Two-third majority rule. This means that for an event to be considered ground truth (a "true seizure"), at least two of the three independent EEG experts had to agree on its presence.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, a traditional MRMC comparative effectiveness study where human readers' performance with AI assistance is compared to without AI assistance was not explicitly described.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as this type of study was not reported. The study focused on the standalone performance of the algorithm against expert-established ground truth.
6. Standalone Performance Study
- Was a standalone performance study done? Yes. The seizure detection component of the QP-160AK was evaluated by comparing its output directly against the "clinical reference standard (ground truth)" established by the expert consensus. The reported PPA and FDR metrics quantify this standalone performance.
7. Type of Ground Truth Used
- Type of Ground Truth: Expert consensus. Specifically, "a two-third majority rule" among three independent EEG experts.
8. Sample Size for the Training Set
- The text does not explicitly state the sample size used for the training set. It only describes the test set.
9. How the Ground Truth for the Training Set Was Established
- The text does not describe how the ground truth for the training set was established. It focuses solely on the ground truth establishment for the test set used for performance evaluation.
§ 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).