(26 days)
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.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).