NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES

• K Number: K973529
• Device Name: NEUROLINE, DISPOSABLE CONCENTRIC NEEDLE ELECTRODES
• Manufacturer: MEDICOTEST A/S
• Date Cleared: 1997-11-20 ( 63 days)
• Product Code: IKT
• Regulation Number: 890.1385
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

Recording muscle activity for Electromyography (EMG) applications. For single patient use only.

Device Description

Neuroline, Disposable Concentric Needle Electrode

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a device called "Neuroline, Disposable Concentric Needle Electrode." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device performance study. It is a regulatory clearance document for a physical medical device.

Therefore, I cannot fulfill your request for the specific information points as they are not present in the provided input.

Regulation Number and Section

§ 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).