(323 days)
The QP-160AK Trend program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data obtained from the EEG-1200A system. This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment when using the information.
The intended use for each of the software's outputs 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 burstsuppression pattern in the EEG.
This device does not provide any diagnostic conclusion about the patient's condition to the user.
The QP-160AK EEG Trend program is a software program stored on electronic media such as CD Rom.
The EEG-1200A OP-160AK Trend program is a device which is installed on the electroencephalograph EEG-1200A Series and records the EEG waveforms and identifies trends in the EEG data over extended periods of time in order for trained health care professionals to observe changes over time.
The QP-160AK design features are as follows:
- Trend display of aEEG and Burst suppression ratio .
- Display of EEG waveform maximum of 64 channels
- DC Trend display including analog inputs .
- Operations of functions by control buttons adapted to touch panels .
- Data management by NeuroWorkbench .
The Nihon Kohden QP-160AK EEG Trend Program is a software-only device intended to be installed on the EEG-1200A series electroencephalograph to record, calculate, and display EEG data. It assists qualified medical practitioners in monitoring brain state, analyzing EEG waveforms using FFT power, and identifying/characterizing burst-suppression patterns. The device does not provide diagnostic conclusions.
Here's an analysis of the acceptance criteria and the study performed, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for the QP-160AK EEG Trend Program in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) for its outputs (aEEG, burst suppression parameters, FFT power). Instead, the performance testing focuses on conformance to design requirements and comparative equivalence to predicate devices.
The "acceptance criteria" are implied to be that the device:
- Performs within its specifications (which are not detailed beyond its functional description).
- Demonstrates substantial equivalence in calculation and display of burst suppression ratio and aEEG compared to predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Conformance to all design requirements | "The QP-160AK EEG Trend Program has undergone validation and verification testing to ensure conformance to all design requirements." |
| Performance within specifications | "These tests verified that the device performed within specifications." (Specific specifications are not provided in this document). |
| Substantial equivalence in calculation and display of burst suppression ratio and aEEG to predicate devices | "Additionally, the system has undergone comparison testing to ensure the substantial equivalence of the calculation and display of the burst suppression ratio and aEEG." |
The conclusion of substantial equivalence states: "The comparison of technological characteristics and performance testing of the QP-160AK EEG Trend Program demonstrate that its safety, effectiveness, and performance are equivalent to the specified predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the number of EEG recordings or the sample size used for the performance or comparison testing. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications. The device is intended to be used by "qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgment." This implies that expert judgment would be the basis for evaluating results, but the specifics of an expert panel for testing are not detailed.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for establishing ground truth or evaluating the device's performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The study described focuses on standalone performance and comparison to predicate devices, not on the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance assessment was done. The document states: "The QP-160AK EEG Trend Program was subjected to safety and performance testing procedures. The QP-160AK EEG Trend Program has undergone validation and verification testing to ensure conformance to all design requirements." This implies that the algorithm's functionality was evaluated on its own merits as designed. Additionally, comparison testing to ensure substantial equivalence of calculations and display to predicate devices also falls under a standalone assessment of the device's output.
7. Type of Ground Truth Used
The type of ground truth used is implicitly expert assessment and comparison to established predicate device outputs, rather than pathology, outcomes data, or a formalized consensus panel. The device is intended to "help the user monitor," "help the user analyze," and "aid in the identification and characterization," suggesting that the "truth" is what expert clinicians would interpret from similar data or how predicate devices present the same information.
8. Sample Size for the Training Set
The document does not specify any sample size for a training set. This is consistent with the device type, which is a trend program for an existing EEG system, rather than a machine learning model that typically requires a large training dataset. Its functionality appears to be based on established signal processing algorithms for aEEG, FFT, and burst suppression.
9. How Ground Truth for the Training Set Was Established
Since a distinct "training set" for a machine learning model is not applicable or mentioned, the method for establishing ground truth for such a set is also not described. The device's performance validation relies on conformance to design requirements and comparison to predicate devices, implying that its underlying algorithms are based on established physiological principles and methods.
§ 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).