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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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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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The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}.

The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.

The EMU40 Headbox requires competent user input, and its output must be reviewed and interpreted by trained medical professionals who will exercise professional judgment in using this information.

The EMU40 Headbox is an electroencephalograph that works in conjunction with XLTEK NeuroWorks software {FDA 510(k) #K980214}. The EMU40 Headbox is used to acquire, digitize, store and transmit physiological signals (such as EEG, pulse and oximetry signals) for EEG studies in research and clinical environments.

This document is a 510(k) clearance letter from the FDA for a medical device called the "XLTEK EMU40 EEG Headbox". It doesn't contain information about acceptance criteria or a study proving the device meets acceptance criteria, as it's primarily a regulatory approval document.

Here's why the requested information cannot be extracted from this document:

1. Acceptance Criteria and Device Performance Table: The document states that the device is "substantially equivalent" to legally marketed predicate devices. This is a regulatory finding based on comparison to existing devices, rather than a detailed performance study with specific acceptance criteria.
2. Sample Size and Data Provenance: This information would be found in a study report, which is not part of this 510(k) letter.
3. Number and Qualifications of Experts: Again, this would be part of a study design and not typically included in a 510(k) clearance letter.
4. Adjudication Method: Not applicable or present in this regulatory document.
5. MRMC Comparative Effectiveness Study: The letter does not mention a comparative effectiveness study.
6. Standalone Performance Study: The letter does not describe a standalone performance study.
7. Type of Ground Truth: Not applicable or present.
8. Training Set Sample Size: Not applicable as this is not a study report.
9. Ground Truth for Training Set: Not applicable.

In summary, this document is a regulatory approval for market clearance, not a technical report detailing performance criteria or study results. Therefore, it does not contain the information required to answer your request.

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The "Ambulatory EEG" is a battery powered electroencephalograph which is intended to acquire and store electroencephalographic signals (electical signals of the brain).

When connected, as part of a system, to the NeuroWorks [FDA 510(k) # K980214], the system is also intended to display and archive there signals.

The "Ambulatory EEG" is a battery powered electroencephalograph which is intended to acquire and store electroencephalographic signals (electical signals of the brain).

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria. The documents are primarily an FDA 510(k) clearance letter and an "Indications For Use" statement for the Excel Ambulatory EEG device.

The documents confirm the device's clearance and intended use but do not include any performance data, acceptance criteria, study methodologies, or results.

Therefore, I cannot provide the requested information in the format specified.

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