(143 days)
Technomed Europe diagnostic needle electrodes are intended to be inserted in the subdermal, muscle or nerve tissue to sense bio-electric, EMG or EEG, signals distally, and are intended to be proximal be connected to electromyography / electroencephalogram recording equipment.
The intended use of the Technomed devices are consistent with Code of Federal Regulations title 21, volume 8 part 882.1350.
Technomed Europe Needle electrode's and accessories consist of a variety of needle electrode's and accessories to be used for bioelectric sensing in the diagnostic field of EEG or EMG.
This document is a 510(k) premarket notification for Technomed Europe's EEG/EMG needle electrodes. It serves to establish substantial equivalence to previously marketed devices. The content provided does not describe a study involving acceptance criteria, device performance, AI, or ground truth establishment. Instead, it focuses on regulatory information required for FDA clearance.
Therefore, I cannot provide the requested information because the provided text does not contain details about: Acceptance criteria, reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth, or how ground truth was established for training data.
The document explicitly states: "{1}------------------------------------------------ J) Intended use: Technomed Europe diagnostic needle needle electrode's are intended to be inserted in the subdermal, muscle or nerve tissue only to sense bio-electric, EMG or EEG, signals distally, and will proximal be connected to: Electromyography/electroencephalogram recording equipment K) Technological Characteristics: The design, materials, chemical composition, packaging and other technological characteristics of the subject devices are considered to be the equivalent of the predicated devices." This sentence, in particular, indicates that the submission relies on the technological equivalence to predicate devices rather than new performance studies with specific acceptance criteria.
§ 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).