(179 days)
The AD-TECH Subdural Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) are intended for temporary (
Subdural electrodes described in this application are single patient use, disposable, sterile and non-sterile devices. The electrodes are invasive as they are placed in contact with the brain. The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physician.
The provided text is a 510(k) summary for AD-TECH Subdural Electrodes. It describes the device, its intended use, and states that its technological characteristics are substantially equivalent to predicate devices.
However, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices, which is a different regulatory pathway than providing performance data against defined acceptance criteria. This type of submission typically relies on comparing the new device's design, materials, and intended use to a legally marketed predicate device, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot populate the requested table and information based on the provided text.
§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).