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The GE EEG module, E-EEGX, the GE EEG headbox, N-EEGX, and accessories are intended to be used with the compatible CARESCAPE monitors for the monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG), and auditory evoked potentials (AEP) of all hospital patients. The device is intended for use by qualified medical personnel only.

The E-EEGX module is a single-width plug-in interface module to be used with CARESCAPE Bx50 V3 patient monitors. It is used with N-EEGX headbox and accessories for monitoring neurophysiological status of all hospital patients by measuring the electroencephalogram (EEG), frontal electromyogram (FEMG) and auditory evoked potentials (AEP).

The E-EEGX module is used with the N-EEGX headbox for monitoring of EEG. FEMG. to stimulate the brain with auditory stimuli, and to measure AEP. The E-EEGX module connects to a N-EEGX headbox which further connects to accessories that connect to the patient.

The EEG, FEMG and AEP measurements are performed by the N-EEGX headbox. The N-EEGX headbox measures the raw EEG waveform data from four real-time EEG waveform channels, FEMG from one channel and AEP from two channels. The N-EEGX headbox is connected to the patient with EEG accessories.

The E-EEGX module transfers the digitized EEG data received from the N-EEGX headbox to the host monitor. The module also generates the stimuli used in the AEP measurement and performs part of the AEP measurement data processing.

Here's a breakdown of the acceptance criteria and the study information for the E-EEGX module, N-EEGX headbox, and accessories, based on the provided FDA 510(k) summary:

The document does not detail specific quantitative acceptance criteria or a study designed to explicitly "prove" the device meets these criteria in the way a clinical trial would for a new therapeutic. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K051883 Datex-Ohmeda S/5 EEG Module, E-EEG and Headbox, N-EEG and Accessories) through non-clinical testing.

The "acceptance criteria" can be inferred from the comparison table and the list of standards the device complies with. The "reported device performance" is essentially that the new device's specifications are either identical or acceptably equivalent to the predicate, and that it meets relevant safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

Since specific "acceptance criteria" with numerical targets and a performance study against them aren't explicitly presented, I've constructed a table based on the comparative effectiveness information provided, which serves as the basis for demonstrating substantial equivalence. The "Acceptance Criteria" column reflects the predicate device's specifications (which the new device aims to match or improve within acceptable limits), and the "Reported Device Performance" column shows the new device's specifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe "test sets" or "data" in the context of clinical or performance data from patients. The evaluation performed was largely based on non-clinical testing (e.g., engineering verification, design validation, safety testing) and comparison of specifications to a predicate device. Therefore, no information on sample size, data provenance, or retrospective/prospective nature of a dataset is provided for this type of submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this 510(k) submission. No expert review of patient data to establish ground truth was conducted or reported, as the submission focused on non-clinical testing and substantial equivalence to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable to this 510(k) submission, as there was no test set involving expert adjudication of patient data.

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

This information is not applicable to this 510(k) submission. The device (E-EEGX module, N-EEGX headbox and accessories) is an electroencephalograph system, not an AI-assisted diagnostic tool that would typically undergo MRMC studies comparing human reader performance. The submission makes no mention of AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable to this 510(k) submission. The device is a hardware module and headbox for physiological measurement, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable to this 510(k) submission, as there was no patient outcome or diagnostic ground truth required for its submission based on substantial equivalence and non-clinical testing. The "ground truth" for showing substantial equivalence was the specifications and validated performance of the predicate device and compliance with recognized international standards (e.g., IEC 60601 series) for medical electrical equipment.

8. The sample size for the training set

This information is not applicable to this 510(k) submission. The device does not appear to involve machine learning or AI that would require a "training set."

9. How the ground truth for the training set was established

This information is not applicable to this 510(k) submission, as there was no training set for an AI/ML algorithm.

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