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510(k) Data Aggregation
(130 days)
The WEE-1200 Wireless Input Unit is intended to acquire, store, record, and transmit the cerebral and extracerebral activity for EEG and sleep studies. The device should be used together with Nihon Kohden specified electroencephalograph via wired or wireless communication to display EEG on the electroencephalograph screen. These data may be used by the clinician in sleep disorder, epilepsies and other related disorders as an aid in diagnosis. The WEE-1200 Wireless Input Unit is designed for use by qualified medical facility such as a hospital or clinic on all patient populations including adult, neonate, infant, child and adolescent subgroups.
The WEE-1200 Wireless Input Unit is a system that can be used in routine EEG testing, epilepsy monitoring, or PSG testing to send the measured EEG waves, ECG waves, EMG waves, EOG waves, and respiration waves from the electroencephalograph by wired or wireless LAN. The electrodes are connected to a mini junction box which is connected to the telemetry unit that is worn by patient or placed near patient.
The measured data can also be stored in the telemetry unit of the WEE-1200 Wireless Input Unit.
Additionally, by connecting a SpO2 sensor and SpO2 adapter to the telemetry unit, SpO2 value and waveform can be measured and displayed on both the electroencephalograph screen and the telemetry unit LCD display.
The provided text describes the regulatory submission for the Nihon Kohden Wireless Input Unit WEE-1200, primarily focusing on its substantial equivalence to predicate devices rather than proving its performance against specific acceptance criteria for diagnostic accuracy.
Therefore, many of the requested details about acceptance criteria, study design for proving device performance (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment), and training set information are not available in this document. This submission is for an Electroencephalograph (EEG) wireless input unit, which is a data acquisition and transmission device, not an AI-powered diagnostic tool. The "performance" being validated here relates to its technical functionality, safety, and electromagnetic compatibility.
However, I can extract information related to the non-clinical testing that was performed to demonstrate substantial equivalence and meet regulatory standards.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific diagnostic performance acceptance criteria (e.g., sensitivity, specificity, AUC) because it is a device for acquiring and transmitting physiological signals (EEG, ECG, EMG, EOG, respiration, SpO2), not a diagnostic algorithm. The acceptance criteria are based on functional performance, safety, and electromagnetic compatibility.
| Criterion Type | Specific Test | Acceptance Standard (Implicit/Explicit) | Reported Device Performance |
|---|---|---|---|
| Functional/Software | Software Unit Test | Code inspection and static analysis. | Tests performed and results indicate compliance (implied by "Software verification and validation testing for the WEE-1200 includes the following tests"). |
| Software Integration Test | Transfer of data and control across a program's internal and external interfaces. | Tests performed and results indicate compliance (implied by "Software verification and validation testing for the WEE-1200 includes the following tests"). | |
| System Test | Comprehensive testing of all required functionality of the device (hardware and software). | Tests performed and results indicate compliance (implied by "Software verification and validation testing for the WEE-1200 includes the following tests"). | |
| Wireless Performance | Wireless Coexistence Test | Performance validation in the presence of wireless emitters in the intended use environment (hardware and software) following FDA Guidance, "Radio Frequency Wireless Technology in Medical Device". | "The wireless transmission performance of the subject device is validated according to the FDA guidance..." indicating it met the requirements. |
| Wireless Network Test | Verify and validate the ability to securely operate in a mixed client enterprise 802.11a/b/g/n network, and to demonstrate the correct quality of service (hardware and software) following FDA Guidance, "Radio Frequency Wireless Technology in Medical Device". | "The wireless transmission performance of the subject device is validated according to the FDA guidance..." indicating it met the requirements. | |
| Wireless Operation Test | Verify and validate the Wi-Fi operation of the device (hardware and software) following FDA Guidance, "Radio Frequency Wireless Technology in Medical Device". | "The wireless transmission performance of the subject device is validated according to the FDA guidance..." indicating it met the requirements. | |
| Safety & EMC Standards | AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. | Tests performed and compliance stated (implied by inclusion in "Standards compliance testing on the device includes"). |
| IEC 60601-1-2:2007 | Medical electrical equipment Part 1-2: General requirements for safety and essential performance collateral standard: Electromagnetic compatibility - requirements and tests. | Tests performed and compliance stated (implied by inclusion in "Standards compliance testing on the device includes"). | |
| IEC 60601-2-26:2012 | Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs. | Tests performed and compliance stated (implied by inclusion in "Standards compliance testing on the device includes"). | |
| ISO 80601-2-61:2011 | Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (for the SpO2 adapter). | Tests performed and compliance stated (implied by inclusion in "Standards compliance testing on the device includes"). | |
| Technical Specifications | Noise, Rejection Ratio, Low/High Cut Filter, Input Impedance, Sampling Frequency (compared to predicates) | Predicate device performance or equivalent (e.g., Noise: < 2.0 micro Vp-p, Rejection ratio: > 105dB, Input impedance: 200M ohm, Max Sampling Frequency: 4000Hz (wired) / 2000Hz) as detailed in the "Technological Characteristics - Substantial Equivalence Discussion" table. | The WEE-1200's specifications are listed in the comparative table, showing performance within acceptable ranges and often improvements over the predicate (e.g., Noise < 2.0 micro Vp-p vs. WEE-1000A's < 3.0 micro Vp-p; Max Sampling Freq: 4000Hz vs. WEE-1000A's 200Hz). Its wireless LAN security uses 802.11 WPA/WPA2, an enhancement from the predicate's original protocol. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of diagnostic accuracy for an AI/ML model on a specific dataset of patient cases. The tests described are non-clinical, involving hardware and software validation, and compliance with technical standards.
- Data Provenance: Not applicable for patient data. The tests are laboratory-based, ensuring the device's technical specifications and compliance with standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This device is a data acquisition and transmission unit, not an AI diagnostic tool that requires ground truth established by medical experts for diagnostic accuracy claims. The "ground truth" here is the adherence to engineering specifications and regulatory standards, evaluated through technical validation tests.
4. Adjudication Method for the Test Set
- Not applicable. No human adjudication of medical findings is involved in the validation described.
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. This is not an AI-assisted diagnostic device, so MRMC studies were not performed. The submission explicitly states "No clinical testing on the subject device was necessary to show substantial equivalence to the predicate."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
- Not applicable. This device is hardware for signal acquisition and transmission, not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
- Technical Specifications and Regulatory Standards: The "ground truth" for this device's performance validation is its adherence to established electrical, safety, electromagnetic compatibility, and wireless communication standards and the functional specifications demonstrated through engineering tests.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML model trained on a dataset of patient cases.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set for an AI/ML model is mentioned or relevant for this device.
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