(137 days)
An Electroencepahlogram (EEG) electrode array intended for use in the ER, ICU and OR for recording of STAT EEGs in patients of 18 years of age and older.
StatNet EEG Headpiece
The provided text is a 510(k) premarket notification letter from the FDA to HydroDot, Inc. regarding their StatNet, Models: 3100, 3110 device. This document primarily focuses on regulatory approval and does not contain the detailed technical information required to answer your request about acceptance criteria and device study results.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or their data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Details on standalone algorithm performance.
- Type of ground truth used.
- Sample size for training sets or how their ground truth was established.
The letter simply states that the FDA has reviewed the 510(k) and determined the device to be "substantially equivalent" to legally marketed predicate devices for its intended use as an EEG electrode array. It outlines general regulatory requirements but does not delve into the specific technical studies or performance metrics that underpinned this determination.
§ 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).