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510(k) Data Aggregation
(343 days)
The Neuronaute is a medical, wireless and mobile equipment, which allows acquisition, record, storage, transmission and displaying of electroencephalogram (EEG) from adult patients.
It can be used with patients in health care facility (data acquisition and reporting) or clinical research environment.
The Neuronaute requires operation by a trained healthcare professional.
The Neuronaute only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.
The Neuronaute is a wearable and wireless equipment, which allows acquisition, recording, storage, transmission and displaying of electroencephalogram (EEG).
The Neuronaute is composed of a textile cap where twenty-one titanium dry electrodes are attached. An electronic box is attached to the cap (EEG recording) associated to batteries. The system operates on battery power only.
The system is connected to a device (i.e. smart phone or a digital tablet) loaded with a separate stand-alone software program ("app"). The app works with a cloud backend service, which allows the user management and authentication, the data storage for application recordings and access to this data via a web-based interface, the devices management and authentication, the recording scheduling, the download of the latest firmware version.
The acquired signals are saved in a universal data format (European Data Format, EDF) that is intended to be visualized by a Physician through the web-based interface.
Here's an analysis of the acceptance criteria and supporting study for the Neuronaute device, based on the provided FDA 510(k) summary:
The Neuronaute device is an electroencephalograph (EEG) system intended for acquiring, recording, storing, transmitting, and displaying EEG from adult patients. The acceptance criteria and supporting studies focus on demonstrating that the Neuronaute performs similarly to or better than predicate devices, and meets relevant electrical, software, and biocompatibility standards.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" with numerical targets and then "reported device performance" in a separate section. Instead, the "Performance Data" and "Technological Characteristics" sections describe testing conducted and the device's measured specifications, often compared directly to predicate devices to demonstrate substantial equivalence. I will synthesize the relevant information into a table, focusing on direct and inferable criteria for signal quality and electrical characteristics.
| Acceptance Criteria (Inferred from Predicate Equivalence & Standards) | Neuronaute Reported Performance |
|---|---|
| Electrical Performance: | |
| Sampling rate | 500 s/s (vs. predicate 256 s/s) |
| Dynamic range | +/- 600mV (vs. predicate +/- 1000 µV - note: units differ, but generally implies a range adequate for EEG) |
| Noise | < 6 µVpp (vs. predicate 3.7 µV typical - comparable or slightly higher, within acceptable range for EEG) |
| CMRR (Common Mode Rejection Ratio) | 115dB (vs. predicate 110dB - better) |
| Input Impedance | 1 Gohm (vs. predicate 100 Gohm - lower, but still high enough for good signal acquisition) |
| Hardware filtering | 125Hz lowpass (vs. predicate 100 Hz Low Pass) |
| Biocompatibility | Compliance with ISO 10993: Cytotoxicity, Irritation, Sensitization testing shown to be substantially equivalent to predicate. Materials (Ti6A14V ELI & OEKO-TEX® yarns) chosen for known biocompatibility. |
| Electromagnetic compatibility (EMC) & Electrical safety | Compliance with IEC 60601-2-26:2002 and FDA Guidance demonstrated, substantially equivalent to primary predicate. |
| Software Validation | Verification and validation according to IEC 62304:2006 and FDA Guidance "General Principles for Software Validation". Results demonstrated meeting requirements for safety, function, and intended use. |
| Signal Quality: | |
| Acceptability of signal quality against gold standard | Testing performed shows similar electrical and signal performance as the Rythmlink Disc Electrodes (K061148, considered gold standard). |
| Alpha Rhythm presence | Physiological tests showed normal presence of alpha modulation in eyes opening/closing task. |
| Impedance levels | Most impedances were below 1 MOhm. |
| Data loss | Chirp and Ramp tests presented no data lost with the current version of software. |
2. Sample Size Used for the Test Set and Data Provenance:
- Physiological Tests (Impedance, Alpha Rhythm):
- Impedance tests: 24 subjects.
- Alpha Rhythm tests: 26 healthy adult subjects.
- EEG signal testing for comparison with Rythmlink Disc Electrodes: The document doesn't explicitly state the number of subjects for this comparison, but it implies a test was conducted.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the mention of "healthy adult subjects," it implies a prospective clinical or research study was conducted internally or with a clinical partner.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not describe the use of experts to establish ground truth for the physiological or comparative EEG signal quality tests. The "gold standard" comparison for EEG signal quality refers to a predicate device (Rythmlink Disc Electrodes), not expert interpretation of data. The physiological tests (Alpha Rhythm, Impedance) likely relied on objective measurements and established physiological markers rather than expert consensus for ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as no expert-based ground truth establishment or adjudication process is described for the tests mentioned. The assessment of signal quality and electrical performance appears to be based on direct measurement and comparison to predefined technical specifications and predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The Neuronaute is described as a device that only acquires and displays physiological signals, with "no claims being made for analysis of the acquired signals with respect to the accuracy, precision and reliability." This means the device does not provide AI-assisted interpretations to be compared against human readers. Its function is data acquisition and display.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
A standalone algorithm performance study was not done, as the Neuronaute explicitly states it makes "no claims ... for analysis of the acquired signals." The "software" (firmware, mobile app, cloud) focuses on verification and validation of its functionality in acquiring, recording, storing, transmitting, and displaying data reliably and safely.
7. Type of Ground Truth Used:
- For EEG signal quality comparison: The "gold standard" was another cleared EEG electrode, Rythmlink Disc Electrodes (K061148). This serves as a technical ground truth for comparison of electrical and signal performance.
- For physiological tests (Alpha Rhythm, Impedance): The ground truth is based on established physiological phenomena (e.g., normal presence of alpha modulation, expected impedance levels) and objective measurements.
8. Sample Size for the Training Set:
The document does not mention any "training set" as it is not an AI/ML device that performs analysis or interpretation. The software validation is for the functionality of data handling and display, not for learning from data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm.
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