(90 days)
The EEG Electrode Template is intended for use as an accessory to support the placement of electroencephalograph (EEG) electrodes.
The EEG Electrode Template is intended to be used in medical environments where EEG electrode placement is required. The device provides a workflow solution to support application of EEG electrodes. The EEG Electrode Template is made from elastic webbing to conform to various head shapes and sizes. The device has between 16 to 21 holes in predetermined locations that are arranged by generally referencing the 10-20 Positioning System. The EEG Electrode Template is placed on the patient's head and is oriented with its nasion marker and secured with its chinstrap to support positioning of EEG electrodes. The elasticity of the device enables flexibility to account for various head shapes and sizes and to avoid interference with intracranial pressure monitoring, ventricular drainage, or other separate devices. Identical to the predicate (K043009), the subject device is non-invasive, non-sterile, and for single patient use.
The provided text describes information about the Rhythmlink International, LLC EEG Electrode Template (K191225). Based on the text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Hole-to-hole spacing | All hole-to-hole spacing was within 5 mm of specifications. |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The text mentions "dimensional characterization of the EEG Electrode Template," implying that the testing was performed on a sample of the manufactured device.
- Data provenance: The data is from non-clinical performance testing of the subject device (EEG Electrode Template) itself. No information about country of origin, retrospective or prospective study is provided as it's not a clinical study involving patients or human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for the non-clinical dimensional characterization was based on the device's specifications, not on expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a non-clinical dimensional test, not a clinical study requiring adjudication of expert opinions.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an EEG electrode template, not an AI-powered diagnostic tool, and the study was a non-clinical performance test.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this question is not applicable. The device is a physical template for electrode placement, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the performance testing was the device's own specifications for hole-to-hole spacing.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).