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Natus NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography who will exercise professional judgment in using the information. The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals. · The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. · The Spike Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system. · aEEG, Burst Suppression, Envelope, Alpha variability, Spectral Entropy trending functionalities included in NeuroWorks are intended to assist the user while monitoring the state of the brain. The automated event marking function of Neuroworks is not applicable to these analysis features. · Neuro Works also includes the display of a quantitative EEG plot, Density Spectral Array (DSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of NeuroWorks is not applicable to DSA. · This device does not provide any diagnostic conclusion about the patient's condition to the user.

Natus NeuroWorks is electroencephalography (EEG) software that displays physiological signals. The software platform is designed to work with Xltek and other select Natus amplifiers (headboxes). Software add-ons and optional accessories let you customize your system to meet your specific clinical EEG monitoring needs.

The provided document describes the Natus NeuroWorks software, an EEG software with functionalities including seizure and spike detection, and various trending capabilities.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance with specific metrics (e.g., sensitivity, specificity, accuracy thresholds for seizure/spike detection). Instead, the demonstration of equivalence for the new trend features relies on qualitative comparison to a predicate device.

The "Comments" column in Table 1: Substantial Equivalence, Trends and other features implicitly states the performance goal for the newly added or enhanced features: to be "Equivalent" or "Same" as the specified predicate device. For example, for Burst Suppression, Envelope Trend, Spectral Entropy, Spectral Edge, Alpha Variability, and R-R interval trend, the comment is "Equivalent: Feature added to Natus NeuroWorks Subject device. With this implementation the Natus NeuroWorks Subject device is now equivalent to NicoletOne and Moberg Predicate devices."

For the DSA / Spectrogram feature, the comment indicates that the feature was already available but improved in terms of common naming, additional color scales for better contrast, and improved spectral resolution (64Hz vs 30Hz), making it "equivalent to NicoletOne predicate device."

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 specify a separate "test set" for performance evaluation of the trend features as typically understood in a clinical study context. Instead, for the newly added or improved trend features (Burst Suppression, Envelope, Spectral Entropy, Spectral Edge, Alpha Variability, DSA), the performance evaluation involved showing that the "resulting graphs are identical" when using the same study data as examples from the NicoletOne predicate device.

The document does not provide information on the country of origin of this "same study data" or whether it was retrospective or prospective.

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)

The document does not specify the number or qualifications of experts used to establish ground truth for the trend feature comparison. The comparison relies on visual identity of trend plots against a predicate device.

For the Seizure Detection and Spike Detection components, the indications for use state they are "intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures/spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces." This implies that the 'ground truth' for these features is ultimately the interpretation by "qualified clinical practitioners," but the document doesn't detail how this was established for the performance study.

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

The document does not describe any formal adjudication method for the performance evaluation of the trend features. The comparison relies on direct graphical comparisons.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The document states: "There were no clinical studies performed for this submission."

The device functions as "computer-assisted tools" for marking electrographic events to "assist qualified clinical practitioners." However, no study measuring improvement in human reader performance with this assistance is presented.

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

While the document doesn't explicitly refer to "standalone performance" metrics for seizure and spike detection (e.g., sensitivity, specificity of the algorithm alone), the performance testing for the trend features was essentially a standalone comparison: the algorithm's output (trend graph) was compared to the predicate's algorithm output using the same input data. The "identical" nature of the graphs suggests successful replication of the predicate's standalone trending functionality.

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

For the trend features (Burst Suppression, Envelope, Spectral Entropy, Spectral Edge, Alpha Variability, DSA), the "ground truth" implicitly used for comparison was the output of the predicate device's algorithms on the same raw EEG data. The goal was to demonstrate that the Natus NeuroWorks algorithms produced graphically identical or equivalent trends.

For the Seizure Detection and Spike Detection, the ground truth is ultimately "electrographic seizures/spikes" as interpreted by "qualified clinical practitioners," but the method of establishing this ground truth for validation is not detailed.

8. The sample size for the training set

The document does not provide information on the sample size for the training set for any of the algorithms. It states that the software was "designed and developed according to a robust software development process" and "rigorously verified and validated," but omits details about machine learning model training.

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

The document does not provide information on how the ground truth for the training set was established. Given the lack of details on training data and methods, this information is not available in the provided text.

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The NeuroWorks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

-The NeuroWorks EEG software allows acquisition, display, archive, review and analysis of physiological signals.
-The Seizure Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system.

-The Spike Detection component of NeuroWorks is intended to mark previously acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system.

-The aEEG functionality included in NeuroWorks is intended to monitor the state of the brain. The automated event marking function of NeuroWorks is not applicable to aEEG.

-NeuroWorks also includes the display of a quantitative EEG plot, Compressed Spectrum Array (CSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of NeuroWorks is not applicable to CSA.

This device does not provide any diagnostic conclusion about the patient's condition to the user.

Natus NeuroWorks is electroencephalography (EEG) software that displays physiological signals. The software platform is designed to work with Xltek and other select Natus amplifiers (headboxes). Software add-ons and optional accessories let you customize your system to meet your specific clinical EEG monitoring needs.

The provided text describes the Natus NeuroWorks EEG software and its FDA 510(k) clearance application. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and the study proving the device meets them.

Specifically, the document states:

• "The NeuroWorks software was designed and developed according to a robust software development process, and was rigorously verified and validated."
• "Results indicate that the NeuroWorks software complies with its predetermined specifications, the applicable guidance documents, and the applicable standards."
• "Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the NeuroWorks software. The results of these activities demonstrate that the NeuroWorks software is as safe, as effective, and performs as well as or better than the predicate device."

While these statements confirm that performance testing was done and the device met its specifications, the actual acceptance criteria (e.g., sensitivity, specificity, F-score targets for seizure/spike detection) and the detailed results of those tests are not explicitly provided in this summary.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative metrics (e.g., target true positive rate, false positive rate for seizure/spike detection). The text broadly states compliance with "predetermined specifications" and "applicable standards."
• Reported Device Performance: Not explicitly stated in terms of quantitative metrics against specific acceptance criteria. The text concludes that the device "performs as well as or better than the predicate device."

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

• Sample Size: Not specified for any performance evaluation.
• Data Provenance: Not specified.

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 specified. The document mentions "qualified clinical practitioners" as the intended users, but doesn't detail their involvement in establishing ground truth for testing.

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

• Not specified.

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

• A MRMC comparative effectiveness study is not explicitly mentioned. The "Seizure Detection" and "Spike Detection" components are described as intended to "assist qualified clinical practitioners," implying a human-in-the-loop scenario. However, the study design and results of such assistance are not detailed.

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

• A standalone performance study focused solely on the algorithm's performance (without human interaction) is not explicitly mentioned as a separate activity with results. The device's indications for use emphasize assisting "qualified clinical practitioners," suggesting an integrated workflow.

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

• Not specified. Given the nature of EEG analysis, expert consensus would be the most probable method, but it is not stated in the document.

8. The sample size for the training set

• Not specified.

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

• Not specified.

In summary: The provided 510(k) summary focuses on the regulatory aspects, intended use, technological comparison to the predicate, and adherence to software development and general performance standards. It lacks the specific clinical performance metrics, study designs, and detailed data provenance typically found in a comprehensive clinical validation study report for an AI/ML medical device. Further details would likely be found in the complete 510(k) submission, which is not fully provided here.

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The Neuroworks is EEG software that displays physiological signals. The intended user of this product is a qualified medical practitioner trained in Electroencephalography. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

• The Neuroworks EEG software allows acquisition, display, archive, review and analysis . of physiological signals.
• The Seizure Detection component of Neuroworks is intended to mark previously . acquired sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp montage according to the standard 10/20 system.
• The Spike Detection component of Neuroworks is intended to mark previously acquired l sections of the adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with full scalp nontage according to the standard 10/20 system.
• The aEEG functionality included in Neuroworks is intended to monitor the state of the 포 brain. The automated event marking function of Neuroworks is not applicable to aFEG.
• Neuroworks also includes the display of a quantitative EEG plot, Compressed Spectrum 1 Array (CSA), which is intended to help the user to monitor and analyze the EEG waveform. The automated event marking function of Neuroworks is not applicalle to CSA.
  This device does not provide any diagnostic conclusion about the patient's condition to the user.

The Neuroworks is EEG software that displays physiological signals.

This document is a 510(k) premarket notification decision letter from the FDA for the Natus Neuroworks, Model 104196. It details the device's indications for use but does not contain information about the acceptance criteria, specific study details, or performance results that would typically be reported for an AI/ML medical device.

The device, Natus Neuroworks, is referred to as "EEG software" with components for "Seizure Detection" and "Spike Detection." However, the letter predates the widespread acceptance and specific regulatory pathways for AI/ML performance evaluation in medical devices. At the time of this letter (2010), the focus was primarily on substantial equivalence to predicate devices under the general controls provisions of the Act.

Therefore, I cannot provide the requested information from the provided text for the following reasons:

• No Acceptance Criteria or Device Performance: The document does not list any quantitative acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, AUC) for the Seizure Detection or Spike Detection components.
• No Study Details: There is no description of a study design, sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
• No AI/ML Specific Evaluations: The document does not mention multi-reader multi-case (MRMC) studies, standalone algorithm performance, or training set details, which are standard for evaluating AI/ML models. While the device has "automated event marking functions," the regulatory review in 2010 did not necessitate the level of detail now expected for AI/ML performance studies.

In summary, the provided document confirms the substantial equivalence of the Natus Neuroworks device to a predicate device based on its indications for use, but it does not include the detailed performance study information required to answer your specific questions about acceptance criteria and how a study proved the device meets them.

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