(296 days)
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.
| Characteristic | Cumulus Functional Neurophysiology Platform Performance | Predicate Device (NeuralScan System) Performance | Comparison Outcome |
|---|---|---|---|
| Intended Use | Acquisition, display, storage of EEG from adults/adolescents to aid diagnosis. Time-stamped. Use in home or healthcare. | Acquisition, display, analysis, storage of EEG and ERP from patients to aid diagnosis. | Same intended use |
| Rx Only or OTC | Rx Only | Rx Only | Same |
| Patient Population | Adolescents and adults | All age groups | SE (Substantially Equivalent) |
| Use Environment | Healthcare/medical facilities, athletic/sports clinics, or outside facilities with qualified medical personnel. Also in home. | Healthcare/medical facilities, athletic/sports clinics, or outside facilities with qualified medical personnel. | SE |
| Biocompatibility | Per ISO 10993-1, confirmed by testing | Per ISO 10993-1 | Same |
| Sterile | No | No | Same |
| Single Use | No | No | Same |
| Shelf Life | Durable goods | Durable goods | Same |
| Power | Li-Ion Battery, USB charging | Li-Ion Battery, USB charging | Same |
| System Components | Patient EEG Headset, mobile device with app, earphones, web dashboard, charging cords | Patient EEG cap, NeuralScan amplifier, laptop, subject response button, ear buds, charging cord | Varies, but deemed SE |
| Interface | Bluetooth (EEG to mobile), WiFi (mobile to cloud) | USB or WiFi to laptop | SE |
| Biopotential signals recorded | Electroencephalography (EEG) | Electroencephalography (EEG), EP/ERP | Same |
| Skin Coupling | Dry electrodes | Custom Electrode Band and Gel | SE |
| Signal recording channels | 16 | Up to 23 | SE |
| EEG input terminals | 16 | Up to 21 | SE |
| Analog to Digital Conversion | 24 bits | 24 bits | Same |
| Sampling Rate | 250 and 500 Hz | 200, 500, 1000 Hz | SE |
| Common Mode Rejection | >110 dB | >110 dB | Same |
| Analysis Software | Embedded and user defined | Embedded, commercially available, and user defined | SE |
| Resolution | 24 bits | 24 bits | Same |
| Band Pass | 0.5 – 50 Hz | 0.1 – 50 Hz | SE |
| Noise | 1.6 µVp-p | 2.3 µVp-p | SE |
| Input Voltage range | +/- 200 mV | +/- 400 mV | SE |
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.
§ 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).