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The 80 Channel EEG is intended to be used as an electroencephalograph: to acquire, display, store, and archive electroencephalographic signals.

The 80 Channel EEG is a digital electroencephalograph

This document is a 510(k) premarket notification for a medical device called the "80 Channel EEG". It seeks to demonstrate substantial equivalence to a predicate device, the "24 Channel Ambulatory EEG [FDA 510(k) K982479]". The document is a regulatory submission and does not contain detailed study information or acceptance criteria for device performance in the way typically seen for AI/ML devices.

Therefore, for aspects related to acceptance criteria, device performance, study design, and ground truth establishment, the requested information cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

1. Table of acceptance criteria and the reported device performance:

   • Not applicable / Not provided. This document is a regulatory submission for substantial equivalence, not a performance study report with specific acceptance criteria (e.g., sensitivity, specificity, accuracy) for a new clinical claim or an AI algorithm. Its focus is on establishing that the new device (80 Channel EEG) is as safe and effective as a previously cleared device (24 Channel Ambulatory EEG) for the same intended use.

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

   • Not applicable / Not provided. This document does not describe a clinical performance study with a test set. It's a submission for a device modification (increasing the number of channels for an EEG machine).

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 / Not provided. There is no mention of an expert-adjudicated test set in this regulatory submission.

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

   • Not applicable / Not provided.

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 / Not provided. This device is an electroencephalograph, not an AI-powered diagnostic tool. The submission is for a device modification (more channels), not a comparative effectiveness study involving human readers and AI.

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

   • Not applicable / Not provided. This is an EEG hardware device, not a standalone algorithm.

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

   • Not applicable / Not provided.

8. The sample size for the training set:

   • Not applicable / Not provided. This document does not pertain to the development or validation of a machine learning algorithm.

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

   • Not applicable / Not provided.

Summary of available information:

• Device Name: 80 Channel EEG
• Predicate Device: 24 Channel Ambulatory EEG [FDA 510(k) K982479]
• Indications for Use: The 80 Channel EEG is intended to be used as an electroencephalograph: to acquire, display, store, and archive electroencephalographic signals.
• Nature of Submission: Special 510(k) Device Modification, suggesting a change to an existing cleared device (likely the 24 Channel EEG was the basis, and this is an upgrade to 80 channels).
• Regulatory Decision: The FDA determined the device is substantially equivalent to predicate devices.

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