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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.

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.

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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.

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.

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