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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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