(78 days)
The Geodesic EEG System 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 is a digital electroencephalography system (EEG) with a dense sensor array of 32 to 256 channels. Like existing digital EEG systems, the Geodesic EEG System is computer controlled and capable of acquiring, storing, and displaying data. It includes scalp conductive electrodes, amplifiers, a central processing unit, and software. The Geodesic Sensor Net is a dense array of scalp electrodes designed to allow rapid application in an even distribution across the head. The Net Amps " consists of multiple amplifiers for physiological signals that are fully software controlled. Net Station® is the software package that provides control of the Geodesic EEG System, digital data storage, and operator-selected waveform displays. The software does not perform any data analysis. Additional components of the system are an articulated arm with extended cable, rack system, various cables, standard components of personal computer (monitor, keyboard, mouse), electrolyte solution, and disinfectant.
This document describes the Geodesic EEG System™, an electroencephalography system. The provided text does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria, beyond general safety and electromagnetic compatibility compliance.
Here's a breakdown of the requested information, with explanations based on the provided text:
-
A table of acceptance criteria and the reported device performance
Acceptance Criteria Reported Device Performance Not specified Not specified General Safety (CAN/CSA C22.2 No. 601.1-M90, UL Std. No. 2601-1) Passed Electromagnetic Compatibility (EN60601-1-2(1993)) Passed Electroencephalograph Standards (IEC 60601-2-26, CAN/CSA C22.2 No. 601.2.26) Passed Biocompatibility (ISO 10993) Passed Explanation: The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." The "Testing conducted" section lists compliance with various international standards related to electroencephalographs, safety, electromagnetic compatibility, and biocompatibility, and states that the "Geodesic EEG System passed all testing." However, these are general compliance standards, not specific acceptance criteria for a device's performance in, for example, detecting certain EEG patterns or achieving a particular level of signal-to-noise ratio.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Explanation: The document states, "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Therefore, there is no information on sample size, test set characteristics, or data provenance. The 510(k) submission relied on substantial equivalence to predicate devices and compliance with general safety and performance standards, rather than a new comparative performance study.
-
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)
Explanation: As no comparative performance or clinical evaluations were submitted, there was no test set for which ground truth needed to be established by experts.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Explanation: Not applicable, as no test set or clinical evaluations were submitted.
-
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
Explanation: No MRMC comparative effectiveness study was done. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Furthermore, the described device (Geodesic EEG System) is a diagnostic tool for measuring and recording EEG data; its software ("Net Station®") "does not perform any data analysis." This indicates it's a data acquisition system and not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Explanation: Not applicable. The device is an EEG acquisition system. Its software explicitly states it "does not perform any data analysis." Therefore, there is no algorithm for standalone performance testing in terms of diagnostic interpretation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Explanation: Not applicable, as no comparative performance or clinical evaluations were submitted that would require the establishment of an independent ground truth for diagnostic purposes.
-
The sample size for the training set
Explanation: Not applicable. The device is an EEG acquisition system, and its software does not perform data analysis, which would typically be a function of a machine learning or AI algorithm that requires a training set. The submission is for a device that measures and records electrical activity, not one that interprets it using learned patterns.
-
How the ground truth for the training set was established
Explanation: Not applicable, for the same reasons as #8.
§ 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).