(184 days)
The Millennium is a 2 or 5 channel electromyograph which provides facilities for ENG and Evoked Potentials testing for a range of clinical applications. Millennium is designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular system in a clinical environment.
The Millennium is a 2 or 5 channel electromyograph which provides facilities for ENG and Evoked Potentials testing for a range of clinical applications.
This looks like a 510(k) clearance letter for the Medelec Millennium device, indicating that it is substantially equivalent to previously marketed devices. However, the provided document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter is a regulatory approval document and typically refers to information submitted by the manufacturer in their 510(k) application. To answer your questions, I would need to see the actual performance study details submitted with that application, which are not present in the provided text.
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets 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).