FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

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K Number

K970639

Device Name

NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K

Manufacturer

MEDICOTEST, INC.

Date Cleared

1997-05-15

(84 days)

Product Code