(182 days)
The Radionics, Inc. NeuroMap™ is intended to be used to assist neurosurgeons in the operating room during functional neurosurgery. The system displays and stores electrophysiological activity of the CNS relayed from electrodes placed within the brain and on the surface of the skin. NeuroMap™ helps the neurosurgeons determine the location of certain brain structures before lesioning is performed by allowing them to examine and analyze the electrical signals.
The system displays and stores electrophysiological activity of the CNS relayed from electrodes placed within the brain and on the surface of the skin.
This FDA clearance letter (K981820) for the Radionics, Inc. NeuroMap™ device does not contain any information about acceptance criteria or a study proving the device meets said criteria.
The letter is a standard 510(k) clearance document, indicating that the device has been found substantially equivalent to a predicate device and can therefore be legally marketed. It focuses on regulatory aspects such as:
- Substantial Equivalence: The primary basis for clearance is that the NeuroMap™ is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness.
- Intended Use: The letter explicitly states the intended use of the device: "to assist neurosurgeons in the operating room during functional neurosurgery. The system displays and stores electrophysiological activity of the CNS relayed from electrodes placed within the brain and on the surface of the skin. NeuroMap™ helps the neurosurgeons determine the location of certain brain structures before lesioning is performed by allowing them to examine and analyze the electrical signals."
- Regulatory Class: The device is classified as Class II.
- General Controls: The letter reminds the manufacturer of general controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details because this information is not present in the provided document.
Such details would typically be found in the 510(k) summary or in the premarket notification submission itself, which is a much more extensive document than the clearance letter. The clearance letter only announces the agency's decision based on its review of that submission.
§ 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).