(90 days)
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
Neuroline Disposable Monopolar Needle Electrode
The provided document is a 510(k) clearance letter from the FDA for a device called "Neuroline Disposable Monopolar Needle Electrode." This document primarily focuses on the regulatory clearance of a physical medical device, not an AI/software device.
The questions you've asked are specifically designed for the evaluation of AI-powered medical devices, requiring information about acceptance criteria, performance studies, ground truth establishment, training sets, and human-in-the-loop performance.
Therefore, based on the provided document, I cannot answer any of the questions about acceptance criteria or study details, as this information is not present nor relevant for a 510(k) clearance of a disposable needle electrode.
The document states:
- Trade Name: Neuroline Disposable Monopolar Needle Electrode
- Regulatory Class: II
- Product Code: GXZ
- Indications For Use: Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
This indicates a physical medical instrument used to record electrical activity from muscles, which does not involve algorithms, AI, or software for its primary function.
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).