(231 days)
The CAIs Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
The CAIs Sensor, generally speaking with regard to the four variations of the sensor, is a circle shaped, pre-gelled array of four electrodes that is applied to the patient's skin to record electrophysiological signals, such as EEG signals.
It is a low impedance, single patient use, disposable electrode sensor designed for application to the frontal/temporal area. The sensor is designed to provide ease of use and electrode placement accuracy. It is in conjunction with CAIx and CAI software of CAI Monitoring System.
The CAIs sensor is attached to the forehead, and the four electrodes placed on the sensor collect EEG signals and transmit them to the CAI monitoring system through the CAI cable.
Each sensor is packed in individual heat-sealed pouches are packed into a cardboard box.
The hydrogel used in the sensors is designed for single use by one patient.
The provided text describes a 510(k) premarket notification for a device named "CAIs Sensor (CAIs-001)". However, the document does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML algorithm or a performance study.
The document primarily focuses on demonstrating substantial equivalence to a predicate device ("Covidien BIS Sensors") based on:
- Indications for Use Comparison: Stating that both devices are applied to the skin for recording electrophysiological signals (e.g., EEG).
- Technological Comparison: Claiming the CAIs Sensor has similar major characteristics affecting safety and performance as the predicate device.
- Non-Clinical Tests: Biocompatibility testing (per ISO 10993 standards), usability engineering, risk analysis (within the CAI Monitoring System), and bench testing for electrical, adhesive performance, and shelf life (per FDA guidance, ANSI/AAMI EC12, and IEC 60601-2-2).
Crucially, the document explicitly states: "Clinical studies were not performed."
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, or any details related to MRMC or standalone performance studies, as these aspects are not present in the provided text. The device is a cutaneous electrode, not an AI/ML diagnostic or predictive device with performance metrics based on algorithms.
§ 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).