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The BWIII system may be used for electroencephalography (EEG) and sleep recordings (Polysomnography) in research and clinical environments. It acquires displays and archives EEG and PSG data for on-screen review, annotation, and event-marking by the user.

The BWIII requires competent user input, and its output must be reviewed and interpreted by a trained physician who will exercise professional judgment in using this information.

The BWIII 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.

BWIII is multi-channel (up to 50 channels) system designed for polysomnography (PSG) and electroencephalograph (EEG) recording application, in sleep lab, hospital or clinical environment under the supervision of a physician, using a laptop or a desktop computer.

The BWIII system consists of four major components: the amplifier unit, head box unit, flash stimulator unit and the power module (all plastic made). The system provides connections for electrodes and sensors, and connects to the computer using an ethernet cable.

The BWIII 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 in the market from different manufactures, they are not part of this submission.

The BWIII 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.

The provided text is a 510(k) summary for the Neurovirtual BWIII device, an electroencephalograph (EEG) and polysomnography (PSG) system. It focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria or a comprehensive study demonstrating device performance against specific metrics.

Therefore, many of the requested elements are not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The 510(k) summary establishes substantial equivalence by comparing the technological characteristics of the BWIII to predicate devices (Neurovirtual BWII, Cadwell Easy Write, Excel Tech PSG-40). It does not specify quantitative acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity) and then report how the BWIII met those criteria. The comparison tables provided here focus on features like number of channels, filter ranges, etc., demonstrating similar specifications, not performance against pre-defined clinical acceptance criteria.

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

This information is not provided. The document does not describe a clinical test set with specific data or provenance.

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

This information is not provided. As there's no described clinical test set, there's no mention of experts establishing ground truth for it.

4. Adjudication Method for the Test Set:

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study is not mentioned or described. The document does not discuss human reader performance, with or without AI assistance. The BWIII is a data acquisition and display system; it does not inherently involve AI for interpretation or assistance for human readers in the way an AI diagnostic algorithm would.

6. Standalone (Algorithm Only) Performance:

This is not applicable in the context of this device. The BWIII is a hardware/software system for acquiring, displaying, and archiving EEG/PSG data. It explicitly states: "The BWIII 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." Therefore, there is no "algorithm only" performance to evaluate in a standalone manner for diagnostic purposes.

7. Type of Ground Truth Used:

This information is not provided.

8. Sample Size for the Training Set:

This information is not provided. The device does not appear to involve machine learning models that require training sets in the typical sense of AI-driven diagnostic tools.

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

This information is not provided.

Summary of the Study and Evidence Presented in the Document:

Instead of a study demonstrating performance against acceptance criteria, the document indicates that safety and effectiveness are established through:

• Substantial Equivalence: The primary method for clearance is by demonstrating the BWIII's substantial equivalence to predicate devices (K932407, K991900, K062533) in terms of its technological characteristics, intended use, and performance specifications (as detailed in the comparison tables). This means showing that the device is as safe and effective as existing legally marketed devices.
• Compliance with Standards: The BWIII is stated to be in compliance with a list of applicable international and national standards for medical device equipment, safety, electromagnetic compatibility, software validation, and quality management systems (e.g., IEC 60601 series, EN ISO 14971, EN ISO 13485, FDA Guidance on Software Validation).
• Non-clinical Testing (Referenced Article): The document states: "In order to demonstrate that the use of EEG / PSG equipment is safe and effective, we have compiled one article from the Journal of Epilepsy and Clinical Neurophysiology (J Epilepsy Clin Neurophysiol 2004; 10(4):191-200) that demonstrates the safety and effectiveness regarding the equipment." The article, "Nonconvulsive Status Epilepticus: Clinical and Electrographic Aspects," is attached as "ATTACHMENT 05" (though the content of the article itself is not provided in the prompt). This suggests the article serves as general scientific evidence supporting the utility and safety of EEG/PSG equipment in clinical practice, rather than a specific study of the BWIII device's performance against defined acceptance criteria.

In conclusion, for the Neurovirtual BWIII, the provided 510(k) summary primarily relies on:

• Comparison to Predicate Devices: Demonstrating that its technical specifications and intended use are similar to already cleared devices.
• Adherence to Recognized Standards: Ensuring the device meets fundamental safety and operational requirements.
• General Scientific Literature: Referencing an external publication to broadly support the safety and effectiveness of the type of equipment.

It does not present a controlled study with specific acceptance criteria, a defined test set of data, expert ground truth establishment, or performance metrics typically associated with evaluating AI/diagnostic devices.

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