(307 days)
Diagnostic electromyography, nerve conduction velocity measurement, evoked response electrical stimulator, evoked response photic stimulator, and evoked response auditory stimulator.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "TOENNIES NEUROSCREEN SYSTEM." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance, specific study details (like sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or the results of any comparative effectiveness studies.
Therefore, I cannot provide the requested table and study details based on the input text. The letter is a regulatory approval document, not a scientific study report.
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).