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510(k) Data Aggregation
(146 days)
The Neurosteer EEG Recorder is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visuals assist trained medical staff to make neurological diagnoses. The EEG Recorder does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The EEG Recorder is intended to be used in a professional healthcare facility environment.
The Neurosteer brain monitoring platform is a portable single-channel EEG that measures and records electrical activity of the brain. An adhesive electrode strip is affixed to the subject's forehead to capture the brain activity signal. The strip is attached to a sensing device that transmits the signal via low-energy Bluetooth (BLE) to a local brain activity monitor.
The brain activity monitor provides technical status indicators about the recording (such as battery level, connection status, and electrode disconnection alert). It can also be used to provide auditory prompt sequences (using an external speaker) during monitoring.
The signal is sent via a secure Internet connection to the cloud (either wireless Wi-Fi or physical Ethernet) where the data is stored according to HIPAA quidelines. Data processing performed in the cloud transforms the raw electrical brain activity signal into a display representation of the signal.
When the Internet connection is available, both the raw and processed data can be viewed in real-time on the brain activity monitor and through the web portal. When the connection is not available, only the raw data can be viewed in real-time on the brain activity monitor.
For the Neurosteer EEG Recorder (K221563), the acceptance criteria and the study proving the device meets these criteria are outlined below, primarily focusing on its technical performance rather than a diagnostic accuracy study involving human readers. This device is an EEG recorder, not a diagnostic AI tool, and thus the performance evaluation is centered on its ability to accurately record and present EEG signals.
1. Table of Acceptance Criteria and Reported Device Performance
The Neurosteer EEG Recorder's performance was assessed against established standards for EEG devices and electrodes. The table below summarizes the key acceptance criteria and the corresponding reported performance.
| Test Category | Specific Test / EC12 Clause | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993-1 (Cytotoxicity, Irritation, Sensitization) | All endpoints (Cytotoxicity, Irritation, Sensitization) within acceptable limits. | All samples passed the acceptance criteria. |
| Electrical Safety | IEC 60601-1 (on Electrode Strip, Sensor, Brain Activity Monitor, charger, power adapter) | All electrical safety parameters within acceptable limits. | All samples passed the acceptance criteria. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 and ETSI EN 301 489-1 (on Electrode Strip and Sensor) | All EMC emissions and immunity parameters within acceptable limits. | All samples passed the acceptance criteria for each test. |
| Battery Safety | IEC 62133 (Sensor's rechargeable lithium-ion polymer battery) | All battery safety parameters within acceptable limits. | All samples passed the acceptance criteria. |
| EEG Essential Performance | IEC 80601-2-26 (on Sensor and Brain Activity Monitor) | All essential EEG performance parameters within acceptable limits. | All samples passed the acceptance criteria. |
| Electrode Performance (ANSI/AAMI EC12) | |||
| 5.2.2.1 (AC Impedance of electrode pairs) | ≤ 3,000 ohm | All samples passed the acceptance criteria. | |
| 5.2.2.2 (DC Offset Voltage of electrode pairs) | ≤ 100 mV (following a 1 min stabilization period) | All samples passed the acceptance criteria. | |
| 5.2.2.3 (Combined Offset Instability and Internal Noise) | ≤ 150 uV (peak-to-peak passband voltage, measured for 5 min after 1 min stabilization) | All samples passed the acceptance criteria. | |
| 5.2.2.4 (Defibrillation Overload Recovery) | - Discharge time to 2V ≤ 2,000ms - Recovery to < 200mV - Electrode voltage decreases at rate < 1mV/s | All samples passed the acceptance criteria. | |
| 5.2.2.5 (Bias Current Tolerance) | ≤ 100 mV (DC offset voltage over 8 hours with 200 nA applied bias current) | All samples passed the acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical "sample size" in terms of number of patients or recordings for the performance data. Instead, it indicates that "All samples" passed the acceptance criteria for each test. For tests like Biocompatibility, Electrical Safety, EMC, Battery Safety, and EEG Essential Performance, the "samples" would typically refer to a statistically representative number of manufactured units or components tested according to the specific standard's requirements. For Electrode Performance (ANSI/AAMI EC12), the samples were "final finished Electrode Strips," implying multiple strips were tested.
- Test Set Sample Size: Not explicitly stated as a number of patients or EEG recordings. For physical and electrical tests, it refers to "samples" of the device components (Electrode Strip, Sensor, Brain Activity Monitor, battery) or the entire device.
- Data Provenance: The tests were conducted according to recognized international and national standards (e.g., ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 62133, IEC 80601-2-26, ANSI/AAMI EC12). This indicates the testing was performed in a controlled, standardized environment, likely by accredited testing laboratories. The document does not specify country of origin for the data, nor does it distinguish between retrospective or prospective, as these are technical performance tests on the device itself rather than clinical studies on patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. The Neurosteer EEG Recorder is intended to record and present EEG signals for trained medical staff to make diagnoses. It does not provide any diagnostic conclusion itself. Therefore, its performance evaluation is based on technical specifications and adherence to standards for signal integrity and electrical safety, not on diagnostic accuracy against a ground truth established by medical experts for specific clinical conditions.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Given that the performance data pertain to technical compliance with standards (e.g., impedance, voltage, safety parameters), there is no adjudication process involving human interpretation or consensus for a "test set" in the diagnostic sense. The results are objective measurements against defined numerical thresholds.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not conducted and is not applicable for this device. The Neurosteer EEG Recorder is not an AI diagnostic tool that assists human readers. Its function is to acquire and display EEG signals. The document explicitly states: "The EEG Recorder does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event." Therefore, there is no human-in-the-loop performance to compare or improve with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
A standalone performance study focused on diagnostic accuracy of an algorithm was not done and is not applicable. The device's primary function is signal acquisition and presentation, not automated diagnosis or interpretation. The "data processing performed in the cloud transforms the raw electrical brain activity signal into a display representation of the signal," but this is for visualization, not automated diagnostic output.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the Neurosteer EEG Recorder is primarily derived from objective technical standards and specifications. For instance:
- For Biocompatibility, the ground truth is defined by the absence of toxicity, irritation, or sensitization as per ISO 10993-5 and -10.
- For Electrical Safety, EMC, and Battery Safety, the ground truth is compliance with the limits and requirements specified in the respective IEC and ETSI standards.
- For EEG Essential Performance and Electrode Performance, the ground truth is meeting the defined electrical and signal integrity parameters (e.g., AC impedance ≤ 3,000 ohm, DC offset voltage ≤ 100 mV) specified in standards like ANSI/AAMI EC12 and IEC 80601-2-26.
There is no "ground truth" derived from expert consensus, pathology, or outcomes data in the conventional sense of a diagnostic device, because this device does not provide diagnostic conclusions.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Neurosteer EEG Recorder is not described as an AI/ML algorithm that requires a training set for diagnostic or predictive purposes. The "data processing performed in the cloud" is described as transforming raw signals into display representations, which typically involves signal processing techniques rather than machine learning requiring a training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set for an AI/ML algorithm in the context of this device.
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