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The BWII system may be used for electroencephalography (EEG) and sleep recordings (polysomnography) in research and dinical environments. It acquires, displays, and archives EEG and PSG data for on screen review, annotation and event marking by the user. The BWII system also allows for computer-assisted, usercontrolled quantitative analysis of EEG.

The BWII system is not intended to replace conventional devices or methods used for EEG and PSG monitoring in critical care or intraoperative settings.

The BWII system requires competent user input, and its output must be reviewed and interpreted by a trained technicians or neurologists who will exercise professional judgment in using this information.

The BWII system does not make any judgment of normality or abnormality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

BWII is multi-channel (up to 25 channels) system designed for electroencephalograph (EEG) and polysomnography (PSG) recording application, in sleep lab, hospital or dinical environment under the supervision of a physician, using a lap top or a desk top computer.

The BWII system consists of three maior components: the Amplifier Unit, the Power Module (Both plastic made) and the BWAnalysis Software (a CD to be installed on a regular PC). The system provides connections for electrodes and sensors, and connects to the computer using an Ethernet cable.

The BWII works with any good quality patient leads / electrodes and sensors (snore, flow, effort belts and position) that have the safety touch connectors and are legally marketed in accordance with FDA requirements. As these accessories are already legally on the market from different manufactures, they are not part of this submission.

The BWII does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic.

This document is a 510(k) premarket notification for the Neurovirtual BWII Digital (Amplifier and Power Module) and BWAnalysis (Software), an electroencephalograph (EEG) and polysomnography (PSG) recording system. The submission aims to demonstrate substantial equivalence to previously cleared devices.

Based on the provided text, a formal study demonstrating the device meets specific acceptance criteria is not present. Instead, the document focuses on establishing substantial equivalence to predicate devices and adherence to relevant safety and quality standards.

Here's an analysis of the requested information based on the provided text:

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

No explicit table of acceptance criteria and reported device performance is included in this 510(k) summary. The submission primarily uses a comparison chart (Section J) to demonstrate technological characteristics are similar to predicate devices, rather than outlining specific performance metrics and acceptance thresholds.

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

Not applicable. The document does not describe a clinical study with a test set of data for performance evaluation. The comparison is based on technological characteristics of the device itself and predicate devices.

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)

Not applicable. No ground truth establishment by experts for a test set is described.

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

Not applicable. No test set adjudication method is described.

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

Not applicable. This device is an EEG/PSG recording and analysis system, not an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case comparative effectiveness study with human readers. The document explicitly states: "The BWII does not make any judgment of normality of the displayed signals or the results of an analysis. In no way are any of the functions represented as being in and of themselves diagnostic."

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

Not applicable. As noted above, the device does not make diagnostic judgments on its own. It's a data acquisition and display system with user-controlled analysis.

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

Not applicable. There is no mention of a ground truth used for performance validation in the context of a clinical study. The device's safety and effectiveness are established through compliance with standards and substantial equivalence to predicate devices, not by direct comparison to a clinical ground truth.

8. The sample size for the training set

Not applicable. This document does not describe a machine learning algorithm that would require a training set.

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

Not applicable. No training set is mentioned in the context of this device.

Summary of the Study and Acceptance Criteria from the Text:

The "study" presented in this 510(k) summary is primarily a technological characteristics comparison study and a standards compliance declaration.

• Acceptance Criteria (Implied):

  • Substantial Equivalence: The primary acceptance criterion for this 510(k) is demonstrating that the BWII Digital and BWAnalysis system is substantially equivalent to legally marketed predicate devices (Cadwell Easy Write and Easy Reader, Excel Tech PSG-40, Excel Tech Neuro Works, Persyst Prism). This implied acceptance is based on similar intended use, technological characteristics, and safety profiles.
  • Compliance with Standards: The device must comply with a list of recognized national and international safety and quality standards (e.g., EN 60601-1, EN 60601-1-1, EN 60601-2, EN 60601-2-26, EN 60601-1-4, EN ISO 14971, EN 13485, FDA Guidance on Software Validation).

• Reported Device Performance:

  • The document provides a comparative table (Section J) outlining the technological characteristics of the BWII system against its predicate devices. This includes hardware specifications (application, number of channels, data communication, material, power source) and software features (platform, impedance, calibration, spectrum analyzer, montage editor). The "performance" is implicitly demonstrated by showing that these characteristics are comparable or equivalent to those of the predicate devices.
  • The manufacturer declares compliance with the listed safety and quality standards, implying that the device meets the performance and safety requirements outlined in those standards.

In essence, the submission does not detail experimental performance data against predefined statistical acceptance criteria typical of some AI/diagnostic device clearances. Instead, it relies on demonstrating that the device is functionally similar, equally safe, and meets the same fundamental technical requirements as other legally marketed devices, as assessed against established medical device standards.

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