(152 days)
Alpha Omega's Sterile Disposable NeuroProbes for MER devices are intended to be used in neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.
Alpha Omega's sterile Disposable Cannulas for MER are intended for guiding the NeuroProbes in Neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.
Alpha Omega's Sterile Disposable Recording Cables for MER are intended to be used in neurosurgery for connecting NeuroProbes to recording and stimulation device.
Alpha Omega's Sterile Disposable NeuroProbes, Cannulas and Recording Cables for MER are indicated for assisting Neurosurgeons, in the operation room during functional neurosurgery, to aid in placement of depth electrodes.
Sterile Disposables for MER
This appears to be a 510(k) clearance letter from the FDA for a medical device. This type of document typically does not contain the detailed study results, acceptance criteria, or performance metrics that you are requesting.
The letter confirms that the device, "Sterile Disposables for MER" from Alpha Omega Engineering, Ltd., has been found "substantially equivalent" to legally marketed predicate devices. This means it has similar technological characteristics and is intended for the same use as a device already on the market, implying that it is as safe and effective.
To provide the information you asked for, I would need access to the actual 510(k) submission, which is often much more detailed than the clearance letter itself and may contain the studies and data you're looking for.
Based on the provided text, I can only state that none of the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth information, MRMC study, standalone performance) is present.
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).