(155 days)
This is an EEG electrode set intended for routine clinical settings where rapid placement of large number or EEG electrodes is desired.
WaveGuard caps consist of Cap fabric Electrodes arranged in a certain layout Chin-strap (placed under the chin) Cable bundle(s) with connector(s) The layout of the electrodes depends on the number of electrodes placed in the cap, and may be placed according to the international 10/20, 10/10 or 10/5 percent system, or according an equidistant "Duke" layout. Caps can have different sizes, ranging from neonatal size (23-weeks old) to large adult head-size, spanning a total of 11 different cap sizes.
The provided 510(k) summary for the WaveGuard™ EEG cap focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and a feasibility study, rather than establishing specific performance acceptance criteria for the device itself.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types cannot be fully extracted as it's not present in the document.
Summary of available information regarding performance:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative performance metrics for the device itself. The submission focuses on demonstrating substantial equivalence to predicate devices through safety, biocompatibility, and electrical characteristics. | Clinical Investigation Result: "High-fidelity recording of brain activity in the extremely preterm babies: Feasibility study in the incubator" concluded that all recordings were successful beginning from the very first baby recorded with this cap design. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated, but the phrase "beginning from the very first baby recorded" suggests a small initial sample for the feasibility study. The exact number of babies or recordings is not provided.
- Data Provenance: Not explicitly stated, but implied to be from a clinical setting where data on "extremely preterm babies" was collected, likely in a prospective manner given it's a "feasibility study." Country of origin is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The document does not specify the number or qualifications of experts used to establish ground truth for the clinical investigation. The "successful recording" outcome suggests expert interpretation of EEG data was involved, but details are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe any adjudication method for the clinical investigation.
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 conducted. The device is an EEG electrode cap, not an AI-powered diagnostic tool, so comparison of human reader improvement with or without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The WaveGuard™ EEG cap is a hardware device for signal acquisition, not an algorithm. Therefore, a standalone algorithm performance study was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the clinical investigation, the "ground truth" seems to be the successful acquisition of high-fidelity EEG recordings as determined by clinical assessment and interpretation. This would inherently involve expert judgment on the quality and diagnostic utility of the EEG data.
8. The sample size for the training set
- Not applicable. This device is a hardware component (EEG cap) and does not involve machine learning algorithms that require a training set.
9. How the ground truth for the training set was established
- Not applicable. As stated above, there is no training set for this device.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).