(217 days)
SLE EMG Electrodes and Accessories are intended for use in recording muscle activity for electromyography applications.
The SLE EMG Electrodes and Accessories device consists of a variety of needle electrodes and accessories to be used in eletromyographic applications.
This FDA 510(k) K981004 for "SLE EMG Electrodes and Accessories" indicates that the device was cleared based on substantial equivalence to predicate devices, not on a new study demonstrating its performance against specific acceptance criteria.
Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in this document. The FDA's 510(k) clearance process for this type of device at the time focused on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new performance studies.
Here's a breakdown of why this information is missing based on the provided text:
- No new clinical or performance study was conducted or reported. The document repeatedly emphasizes substantial equivalence to existing devices.
- The "Technological Characteristics" section specifically states: "The design, materials, H. composition, packaging, and other chemical technological characteristics of the subject device are considered to be the same as the technological characteristics of the predicate devices." This means the manufacturer didn't claim novel technology requiring new performance metrics.
- The FDA clearance letter confirms: "We have determined the device is substantially equivalent...".
However, if we were to hypothesize what would be required for such a device if a performance study were conducted, and how the information would be presented in a typical regulatory submission (though not present here), it might look like this (purely illustrative, based on common neurophysiology electrode testing):
(Hypothetical, as this information is NOT in the provided document)
1. A table of acceptance criteria and the reported device performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance (Hypothetical) |
|---|---|---|
| Impedance | 20 dB | > 25 dB |
| Baseline Drift |
§ 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).