(86 days)
The Neuroline Subdermal Needle Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electromyography (EMG), Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are sterile and for single patient use only.
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The provided document is a 510(k) clearance letter from the FDA for the Neuroline Subdermal Needle Electrode. This type of letter declares substantial equivalence to a predicate device and permits marketing. It is not a study report or a summary of acceptance criteria and performance data.
Therefore, the requested information (acceptance criteria, device performance table, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies, ground truth establishment, training set size) is not available within this document.
The document primarily focuses on regulatory approval based on substantial equivalence, rather than detailing the technical specifications and clinical study results that would typically contain the information you've requested.
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).