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The COGNISION System is for use by qualified clinical professionals in private practice offices or small clinical settings for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and auditory evoked potentials (AEP) information.

The COGNISION™ EEG/EP System is a combination device for reduced montage recording and display of electroencephalographic (EEG) and evoked potentials (EP) test data. The system uses elastic bands to accurately position 10 electrode pods around the head (7 recording channels, 2 linked mastoids, and 1 common). EEG signal amplification, conditioning, and A/D conversion is performed by electronic circuits closely coupled to the electrode pods through short flexible printed wires. The headset is connected by a cable to a handheld control unit and data acquisition box (HCU). A lithium-ion battery in the HCU is used to power the system. The HCU communicates via a wireless data link to a Windows PC to stream EEG data. HydroDot® Biosensors (from HydroDot Inc., and not included as part of this submission) are inserted into each electrode pod to electrically couple the electrode pods to the subjects scalp. Software on the PC is used to setup the tests and view and evaluate the resultant test data using standard EEG/EP display methods. Calibrated audiometric earphones (from E-A-R Auditory Systems) can be plugged in to the amplifier A/D converter box to deliver various auditory stimuli to produce evoked potential EEG responses.

The provided text describes the COGNISION™ EEG/EP System and its equivalence to predicate devices, but it does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner of a clinical or comparative effectiveness study. Instead, it focuses on non-clinical performance data (bench testing) and general statements about design validation.

Here's an breakdown of the information that is available and what is missing based on your request:

Acceptance Criteria and Device Performance

The document presents non-clinical (bench) acceptance criteria and states that the device passed these tests. It does not provide "reported device performance" in terms of clinical outcomes or performance metrics against specific acceptance thresholds in a clinical study.

Table of Acceptance Criteria and Stated Device Performance (Non-Clinical):

Missing Information from the Request:

The provided text does not contain the following information which is typically found in a clinical study report proving a device meets acceptance criteria:

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "Patients with a neurological condition were observed in an environment consistent with the intended use and the design validation met all acceptance criteria" under "Clinical Performance Data." However, it does not provide details on the number of patients, their demographics, the data provenance, or whether the study was retrospective or prospective. The "test set" in the context of the bench tests is an "automated test set" and does not involve human subjects.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. The "ground truth" for the non-clinical tests would be the known inputs from the biosignal generator and fixtures. For the brief mention of clinical validation, no details about expert adjudication or ground truth establishment are given.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable and not mentioned for the non-clinical tests. Not mentioned for the brief clinical validation comment.

4. 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: This information is not available in the document. The device description does not imply AI assistance, and no MRMC study details are provided.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the device as an "EEG/EP System" for acquisition, display, analysis, storage, reporting, and management of information by "qualified clinical professionals." It doesn't detail an algorithm-only performance assessment in the context of diagnostic or interpretive outcomes. The self-tests and performance tests are essentially standalone evaluations of the hardware/software functionality, but not in the sense of a standalone diagnostic algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, the ground truth is derived from the known, precisely controlled signals generated by the "integrated biosignal generator" and other electronic fixtures. For the "clinical performance data" that is mentioned, the method for establishing ground truth for the neurological conditions or observed outcomes is not specified.

7. The sample size for the training set: Not applicable, as this device is not described as an AI/ML device that requires a training set in the conventional sense. Its functionality is based on signal acquisition and processing.

8. How the ground truth for the training set was established: Not applicable, for the same reason as point 7.

In summary, the document describes the non-clinical (bench) testing of the COGNISION™ EEG/EP System and declares that it passed these tests, affirming its adherence to engineering specifications. It makes a general statement about clinical validation but lacks specific details typically found in studies proving device performance against acceptance criteria in a clinical setting.

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