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The AE-918P EEG Neuro Unit is an 8 channel EEG measuring unit that connects to a Nihon Kohden patient monitor and is intended to monitor brain function. The unit amplifies and analyzes EEG and displays the EEG waveform and the result of analysis on the patient monitor.

The AE-918P EEG Neuro Unit includes the calculation of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include quantitative EEG functions such as SEF, MDF, PPF, TP, CSA, DSA, %Theta, %Alpha, %Beta, %Gamma, Abs Delta, Abs Alpha, Abs Beta, and Abs Gamma. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveform. The aEEG functionality included in the AE-918P EEG Neuro Unit is intended to monitor the state of the brain.

The device is intended for use by medical personnel in any location within a medical facility, physician's office, laboratory, clinic or nursing home under direct supervision of a medical professional.

The AE-918P is an 8 channel digital Electroencephalography (EEG) that connects to a Nihon Kohden patient monitor. It receives EEG data from patients and digitizes the signals, the waveforms and analysis are displayed on a Nihon Kohden Patient Monitor.

The AE-918P is contained in a small enclosure that contains the EEG amplifier and digital circuitry. This enclosure is mounted to the bottom of the patient monitor and connects to the patient monitor through the multilink cable.

The Nihon Kohden AE-918P Neuro Unit is an 8-channel EEG measuring unit that connects to a Nihon Kohden patient monitor. It amplifies and analyzes EEG and displays the EEG waveform and analysis results on the patient monitor, intended for monitoring brain function.

Here's an analysis of its acceptance criteria and the study proving its performance, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity. Instead, the performance testing focuses on ensuring the device meets established safety and performance standards for electroencephalographs and demonstrating substantial equivalence to predicate devices. The "reported device performance" is largely qualitative, stating that the device "performed within specifications" and was "equivalent in safety and effectiveness" to its main predicate.

2. Sample Size Used for the Test Set and the Data Provenance

The document explicitly states: "No Clinical testing was required." This indicates that the performance testing for this device primarily relied on bench testing, comparison to predicate devices, and internal validation/verification testing according to design control processes. Therefore, there is no test set of patient data and consequently, no specified data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

As no clinical testing was performed and no patient-specific "test set" was used, there were no experts used to establish ground truth for such a set. The "ground truth" for the device's technical specifications and performance was based on engineering validation against established standards and comparison to well-characterized predicate devices.

4. Adjudication Method for the Test Set

Since no clinical test set was used, there was no adjudication method employed for a test set.

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

No MRMC comparative effectiveness study was done. This device is an EEG measuring unit, not an AI-assisted diagnostic tool that would typically involve human readers interpreting AI output. Its function is to amplify, analyze, and display EEG waveforms and quantitative measures for medical personnel to interpret in conjunction with the original waveform.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device's functionality involves "amplifies and analyzes EEG and displays the EEG waveform and the result of analysis on the patient monitor." The quantitative EEG measures "should always be interpreted in conjunction with review of the original EEG waveform." This implies the device provides analytical output that is not intended to be used in a standalone, algorithm-only fashion without human interpretation and review of the raw EEG data. The performance testing verified the device's ability to calculate and display these measures and trends accurately, rather than its diagnostic performance in a standalone mode.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating the device's performance was primarily:

• Engineering specifications and design requirements: Verifying that the device met its intended technical parameters.
• Regulatory standards: Conformance to IEC 60601 series for safety and performance of medical electrical equipment, particularly for electroencephalographs.
• Predicate device characteristics: The comparison testing aimed to show "substantial equivalence" of the calculation and display of EEG trends to those of legally marketed predicate devices. This indicates that the established, accepted performance of existing devices served as a benchmark for "ground truth."

8. The Sample Size for the Training Set

The document does not mention any "training set" of data. As previously noted, no clinical testing was required, and the device's validation appears to be based on engineering tests and comparison to existing technologies, not on machine learning or AI models that require specific training data.

9. How the Ground Truth for the Training Set Was Established

Since there was no mention of a training set, the method for establishing its ground truth is not applicable to this submission.

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