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The Cumulus Functional Neurophysiology Platform is intended for the acquisition, display and storage of electroencephalograph (EEG) obtained by placing electrodes on the head of adults and adolescent patients. The EEG signals are time-stamped.

The system can be used in the patient's home or a health care facility.

The Cumulus Functional Neurophysiology Platform is comprised of the Cumulus Headset which records EEG signals that are time-stamped.

The Cumulus software application runs on a mobile device running android software. The software has graphical user interface that provides guidance to the user to place the headset correctly. The EEG data is received from the headset via Bluetooth. The data received is synchronised and timestamped between the headset and app.

The Cumulus Medical Device Hub provides the user interface for health care professionals to view, download and review data from the recordings.

The Platform components are:
• Cumulus EEG Headset with embedded software, which includes:
• An adjustable shell into which 16 Ag/AgCl EEG conductive sensors are attached.
• A zippered pocket for holding the detachable electronics.
• Interface buttons, LEDs, micro USB socket.
• Plastic-encased 'Puck' electronics.
• Cumulus Mobile device with installed Cumulus Mobile App.
• Disposable mastoid sticky sensors
• Earphones
• Device stand
• Headset and mobile device chargers

Patient contacting materials are biocompatible, commercially sourced and are used in the headset without modifications.

The device and accessories are not sterile, nor intended to be sterilized.

The Cumulus Functional Neurophysiology Platform is intended for the acquisition, display, and storage of electroencephalograph (EEG) signals obtained by placing electrodes on the head of adults and adolescent patients. The EEG signals are time-stamped. The system can be used in the patient's home or a healthcare facility.

Here's a breakdown of the acceptance criteria and the study information:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list acceptance criteria in a quantitative format for the functional performance of the EEG acquisition. Instead, it demonstrates substantial equivalence to a predicate device (NeuralScan System, K192753) based on a comparison of technological characteristics. The "reported device performance" is derived from these comparisons.

Note: "SE" in the "Comparison Outcome" column refers to "Substantially Equivalent," meaning the differences do not raise new questions of safety or effectiveness when compared to the predicate device.

2. Sample size used for the test set and the data provenance

The document states that clinical testing was not required for this product category. Therefore, no "test set" in the context of a clinical performance study for diagnosing conditions using the EEG recordings is described or referenced. The assessment is based on non-clinical bench testing and comparison to an existing device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As no clinical efficacy study or diagnostic accuracy study with a "test set" was conducted or required, there were no experts used to establish ground truth in this context.

4. Adjudication method for the test set

Not applicable, as no clinical test set for diagnostic performance was used.

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

No MRMC comparative effectiveness study was performed or mentioned. This device is an EEG acquisition and display platform, not an AI-assisted diagnostic tool for interpretation.

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

No standalone algorithm performance study was reported. The device's primary function is data acquisition and display, which serves as input for human interpretation.

7. The type of ground truth used

Not applicable for clinical efficacy, as the submission focuses on hardware and software performance for signal acquisition and display (substantial equivalence). For the non-clinical bench testing (electrical safety, EMC, hardware/software verification, biocompatibility, human factors, etc.), the "ground truth" would be established by the specifications of the relevant international standards (e.g., IEC 60601 series, ISO 10993 series).

8. The sample size for the training set

Not applicable. This device is an EEG acquisition and display system; it does not involve AI/ML algorithms that require a "training set" for diagnostic performance.

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

Not applicable.

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