(204 days)
The Nexstim eXimia Navigated Brain Stimulation System (NBS System) is indicated for non-invasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.
Not Found
This appears to be a 510(k) clearance letter from the FDA, not a study report or clinical trial. Therefore, the provided document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.
The letter primarily:
- Confirms that the device, Nexstim eXimia Navigated Brain Stimulation System, has been reviewed and determined to be substantially equivalent to a legally marketed predicate device.
- Outlines general regulatory compliance requirements.
- Includes an "Indications for Use Statement" detailing what the device is approved for.
Without a separate study report or clinical trial documentation, it's impossible to answer the questions you've posed. The FDA clearance letter focuses on regulatory approval based on substantial equivalence, not on a detailed presentation of performance data from a specific study against predefined acceptance criteria.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).