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The Natus Brain Monitor Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/ SleepWorks™ software to acquire scalp and intracranial electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The Natus Brain Monitor Amplifier is intended to be used by trained medical professionals, and is designed for use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.

The Natus Brain Monitor family of amplifiers are intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks™/SleepWorks™ software to acquire electroencephalographic (EEG) signals as well as polysomnographic (PSG) signals. The Natus Brain Monitor family of amplifiers are intended to be used by trained medical professionals, and are designed for use in clinical environments such as hospital rooms, clinics, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use.

The Natus Brain Monitor (Natus Embla NDx, Natus Embla SDx) are comprised of a base unit and a breakout box. It is part of a system that is made up of a personal computer, software, a photic stimulator, an isolation transformer, video and audio equipment, networking equipment, and mechanical supports. EEG and other physiological signals from electrodes placed on the head and body as well as other accessories such as pulse oximeters, respiratory effort and airflow sensors can be acquired by the amplifiers. The amplifiers include sensor inputs for respiratory effort and airflow as well as snoring. The amplifiers include an integrated pressure sensor and pulse oximeter module. These signals are digitized and transmitted to the personal computer running the Natus NeuroWorks/SleepWorks software. The signals are displayed on the personal computer and can be recorded to the computer's local storage or to remote networked storage for later review.

Here's a breakdown of the acceptance criteria and study information for the Natus Brain Monitor, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a pass/fail threshold format for each performance metric. Instead, it provides a comparison to predicate devices, implying that performance comparable to or better than the predicates is acceptable. The performance is reported in the "Comparison to Predicate Device" table.

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 describes bench testing for performance validation rather than a clinical study with a "test set" of patient data. Therefore, details about sample size (patients) or data provenance are not applicable in the context of this submission. The testing was performed internally by the manufacturer.

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. The device is an electroencephalograph, and the testing described is technical performance validation against engineering and safety standards, not a diagnostic or AI-driven system requiring expert-adjudicated ground truth from patient studies.

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

Not applicable, as there was no patient "test set" with ground truth requiring adjudication. The testing involved measurements against predetermined technical specifications and compliance with standards.

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 such study was conducted or reported. This device is a hardware amplifier for acquiring physiological signals, not an AI-assisted diagnostic tool.

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

This refers to an algorithm's performance without human intervention, typically in AI/software. This is not applicable to the Natus Brain Monitor, which is a hardware device for signal acquisition.

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

The "ground truth" for the performance testing was technical specifications, engineering requirements, and international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, IEC 62366, ISO 80601-2-61). The device's performance was measured against these predefined technical benchmarks, rather than clinical outcomes or expert labels.

8. The sample size for the training set

Not applicable. This device is a hardware amplifier, not an AI/machine learning system that requires a "training set."

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

Not applicable for the same reason as above.

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