(34 days)
The Geodesic EEG System™ 300 (GES 300) is intended to measure and record the electrical activity of the patient's brain. It can be used on adults, children, and infants.
The Geodesic EEG System™ 300 (GES 300) is a digital electroencephalograph system (EEG) with dedicated electrodes. It consists of an amplifier, computer, software . Geodesic Sensor Net® (electrodes), and additional components such as cables. Modifications which constitute the GES 300 include a compact amplifier, software upgrade, additional display modes and tools, and options for computer configuration.
The provided text describes a 510(k) submission for the Geodesic EEG System™ 300 (GES 300). However, it explicitly states:
"Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
This means that the submission does not include information about acceptance criteria, device performance, or a study that proves the device meets specific criteria in terms of clinical effectiveness or diagnostic accuracy. Instead, the submission focuses on demonstrating that the GES 300 modifications (compact amplifier, software upgrade, additional display modes and tools, and computer configuration options) do not alter the technological characteristics of the predicate device (Geodesic EEG System™ K012079) and that basic verification and validation testing has been conducted to ensure the device functions as intended.
Therefore, for all the requested information, the answer is that the details are not available or not applicable based on the provided text.
Here's a breakdown of why each specific point cannot be addressed:
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A table of acceptance criteria and the reported device performance
- Not available: The document explicitly states "Comparative performance testing and clinical evaluations were not submitted." This implies no specific performance metrics or acceptance criteria for clinical efficacy were provided in this 510(k) submission. The "verification and validation testing" mentioned is likely related to engineering functionality and safety, not clinical performance.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available/Not applicable: Since no comparative performance or clinical evaluations were submitted, there is no "test set" in the context of clinical data.
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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 available/Not applicable: No clinical test set means no ground truth established by experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available/Not applicable: No clinical test set means no adjudication method described.
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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 available/Not applicable: No comparative effectiveness study was done. Also, this device is an EEG system, not typically an "AI" device that assists human readers in interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not available/Not applicable: No standalone performance study was done. This device is an EEG recording system, not an algorithm performing interpretation independently.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not available/Not applicable: No clinical ground truth was used as no clinical performance study was submitted.
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The sample size for the training set
- Not available/Not applicable: No clinical training set information is provided, as no clinical performance study was submitted.
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How the ground truth for the training set was established
- Not available/Not applicable: No clinical training set information means no ground truth establishment method.
In summary, the 510(k) submission for the GES 300 focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and basic safety/functionality testing, rather than novel clinical performance studies.
§ 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).