(414 days)
The PressOn™ electrode is intended for use in the recording of the electroencephalogram (EEG), the evoked potential (EP), or as ground and reference in an EEG or EP recording.
The PressOn electrode is a single-use, disposable EEG electrode. The electrode is very small, with a footprint of approximately 0.6 cm and a very thin (~0.004 inch) height profile. It is made from a super-elastic Nitinol and is flexible. The electrode has 3 legs (a tri-pod configuration) that each terminate in micro-teeth that penetrate the top layers of the scalp dermis during subdermal electrode placement.
The PressOn electrode is used in conjunction with an accessory PressOn lead that is provided non-sterile and is reusable. The lead is approximately 48" in length and is used to connect one of the PressOn electrodes to a commercially available EEG monitor. The EEG monitor/ equipment is not part of the PressOn device offering.
This a 510(k) Premarket Notification for the PressOn™ electrode. The document states that the device is "substantially equivalent to legally marketed needle electrodes that are in commercial distribution". Therefore, no specific acceptance criteria or studies proving device performance against such criteria are explicitly detailed in this document, as the FDA has determined it is substantially equivalent to a predicate device.
The document indicates that the device underwent "biocompatibility, bench and performance testing and demonstrated acceptable results in all testing." However, the details of what these acceptable results were, the specific acceptance criteria, or the study methodologies and data, are not provided for the electrode.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not available.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method: Not available.
- MRMC comparative effectiveness study: Not applicable, as this is a physical medical device (electrode), not an AI-assisted diagnostic tool.
- Standalone performance study: Not available, "performance testing" is mentioned but no details.
- Type of ground truth used: Not applicable as there is no diagnostic outcome being evaluated.
- Sample size for the training set: Not applicable as there is no mention of a training set or a machine learning algorithm.
- How the ground truth for the training set was established: Not applicable.
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).