(216 days)
The iSyncWave is intended for prescription use in a health care facility to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns.
iSyncWave™ is a wireless EEG measurement device that applies dry EEG measurement technology to an international 10-20 system compliant size-adjustable headset. iSyncWave™ measures 19 channel EEG in real time and transfers the data through BLE wireless connection to the iSyncWave™ App. The data is displayed and recorded via the iSyncWave™ App. iSyncWave™ uses dry electrode technology, which doesn't require a preparation process(e.g., applyinq conductive gel), to obtain high quality EEG signals. Before measuring the EEG, you can check the impedance of each electrode under the impedance check screen in the iSyncWave™ app. An EEG amplifier, analog-to-digital converter and Bluetooth are built in the device. All EEG signal is sampled at 250 Hz and then converted to digital data at 24-bit resolution. This device measures overall EEG data using 19 EEG electrodes, 1 Reference cable and 1 ground electrode. The measured data can be digitally converted to common average, longitudinal and transverse montage. The measured data is automatically uploaded to a secure cloud server via Wi-Fi connection and saved securely. The data saved in the cloud server can be seen on the iSyncWave™ app.
The iSyncWave is an electroencephalograph (EEG) device intended for prescription use in healthcare facilities to acquire, transmit, display, and store EEG and optional auxiliary signals for adults and children (excluding newborns). The primary study proving the device meets its acceptance criteria is a non-clinical bench test comparison to a predicate device, the WR19 System by Zeto Inc. (K172735).
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the iSyncWave are primarily demonstrated through a substantial equivalence comparison to its predicate device, the WR19 System (K172735), and compliance with various international standards for medical electrical equipment. The "reported device performance" entries below reflect how the iSyncWave either matches or is deemed equivalent to the predicate, or meets the technical requirements of the standards.
| Acceptance Criteria Category | Acceptance Criteria (from predicate/standards) | Reported iSyncWave Performance | Remark/Conclusion (from study) |
|---|---|---|---|
| Indications for Use | Intended for prescription use in a healthcare facility to acquire, transmit, display and store primarily EEG and optional auxiliary signals for adults and children, not including newborns. | Same as predicate. | Equivalent as predicate |
| User Interface | Operator control, visual indicators. | Operator control, visual indicators. | Equivalent as predicate |
| System Components | Headset, Electrodes, Charger, Charging cable, Software. | Headset, Electrode, Software. | Equivalent as predicate (Charger not included in iSyncWave™ but functionality achieved) |
| Signals Acquired | Scalp EEG, Accelerometer. | Scalp EEG. | Equivalent as predicate (Accelerometer not included but not considered a significant difference) |
| Power Supply | 1 x 2050mAh 3.7V Lithium-Ion battery. | 2950 mAh 3.7V Lithium-Ion battery. | Equivalent as predicate (iSyncWave™ has 50% higher battery capacity) |
| Battery Charging | Via USB connector connected to USB wall charger. | Via USB connector connected to USB wall charger. | Equivalent as predicate |
| Typical Charging Time | 0.5 - 6.0 hours. | 0.5 - 2.5 hours. | Equivalent as predicate (iSyncWave™ speedy charging) |
| Operating Time | 6 - 7 hours. | 7 hours. | Equivalent as predicate |
| Typical Use Duration | 20 - 60 minutes. | 10 - 20 minutes. | Equivalent as predicate (iSyncWave™ optimized for quick usage) |
| Dimensions | 214 x 274 x 144 mm (Complete headset with electrodes). | 250 x 243 x 150 (mm). | No significant difference |
| Weight | 120 dB (typical). | > 89 dB (typical). | Equivalent as predicate (Although lower hardware CMRR, software implements additional 50/60 Hz notch filter with ~70 dB attenuation) |
| Input Impedance (EEG) | 1000 GOhm. | 1000 GOhm. | Equivalent as predicate |
| A/D Conversion (EEG) | 24 Bit. | 24 Bit. | Equivalent as predicate |
| Electrode Type | Active, dry. | Dry. | No significant difference (Instead of active electrode, AFE is added to conventional EEG amp) |
| Contact Quality/Impedance | Contact quality monitoring performed. | Contact quality monitoring performed. | No significant difference |
| Measurement (Real-time) | Real time throughout the recording/test. | Real time throughout the test. | (During recording, all computing resource is dedicated to EEG acquisition) |
| Firmware | WR19 headset is controlled by a firmware. | iSyncWave™ headset is controlled by a firmware. | Equivalent as predicate |
| Data Center Application | WR19 sends data to the data center application in the cloud. | iSyncWave™ sends data to the data center application in the cloud. | Equivalent as predicate |
| Client Application | Presents waveforms, controls EEG session, and offers standard EEG transformations; records and retrieves EEG waveforms. | Presents waveforms, controls EEG session, and offers standard EEG transformations; records and retrieves EEG waveforms. | Equivalent as predicate |
| Electrode Material | Ag/AgCl coated. | Ag/AgCl coated. | Equivalent as predicate |
| Electrode Mounting Mechanism | Semi-rigid wearable headset with adjustable electrode positions. | Electrode position can be adjusted to International 10-20 electrode location on the expandable headset structure. | No significant difference (Special mechanical structure maintains 10-20 system and contact pressure) |
| Typical Usage Setting | Intended for use for Routine clinical EEG where rapid placement of EEG electrodes as per the 10-20 EEG system is required. | Intended for use for Routine clinical EEG where rapid placement of EEG electrodes as per the 10-20 EEG system is required. | Equivalent as predicate |
| Regulatory Compliance Standards Adherence | Basic safety and essential performance, EMC, Usability, Software lifecycle, Biocompatibility. | Adherence to IEC 60601-1, IEC 60601-1-2, IEC 80601-2-26, IEC 60601-1-6, IEC 62304, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23. | None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazard. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not specify a separate "test set" in terms of patient data for evaluating diagnostic performance. The studies cited are primarily non-clinical bench tests focused on verifying compliance with various electrical, safety, software, and biocompatibility standards. The data provenance is related to these engineering and safety tests, not patient data from a specific country or whether it was retrospective/prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The regulatory submission focuses on engineering and safety compliance, and substantial equivalence to a predicate device, rather than a clinical performance study requiring expert ground truth assessment for a diagnostic task.
4. Adjudication Method for the Test Set
This information is not applicable as there is no described clinical test set involving patient data and multiple expert readings for adjudication.
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
There is no mention of a Multi Reader Multi Case (MRMC) comparative effectiveness study being performed or any assessment of human reader improvement with or without AI assistance. The device functions as an EEG acquisition and display system; the document does not describe AI-driven interpretation or assistance in EEG reading for diagnostic purposes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of a standalone algorithm performance study. The device is described as an EEG acquisition and display system, not one that performs automated diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the non-clinical bench tests would be the established technical specifications and performance limits defined by the international standards (e.g., IEC 60601-1 for basic safety, IEC 80601-2-26 for electroencephalographs performance), and the technical characteristics of the predicate device. This is not a clinical "ground truth" derived from patient outcomes or expert reads.
8. The Sample Size for the Training Set
This information is not provided as the submission describes a medical device for acquiring and displaying physiological signals (EEG), not a machine learning or AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no described training set for a machine learning or AI algorithm.
§ 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).