(44 days)
The Electrode Market Disposable Surface Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP). The electrodes are designed for single use.
Electrode Market Disposable Surface Electrodes are non-invasive. Cutaneous devices are used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG), surface Electromyography (EMG) and Evoked Potentials (EP). The electrodes are designed for single use. Because of the adhesive nature of the gel, no securing material is required for fixating the electrode to the patient's skin. The electrodes with lead wire have a safety DIN 42802 connector, several lengths and color combinations.
This document describes the FDA's 510(k) clearance for Electrode Market Disposable Surface Electrodes (K211839). The information provided is primarily focused on demonstrating substantial equivalence to a predicate device rather than detailing studies to prove the device meets specific acceptance criteria in the context of AI/ML performance.
Therefore, the following information is not present in the provided text:
- A table of acceptance criteria and reported device performance (for AI/ML).
- Sample sizes for test sets, data provenance, number of experts, qualifications of experts, and adjudication methods for establishing ground truth for test sets.
- Information regarding a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
- Information regarding a standalone algorithm-only performance study.
- The type of ground truth used (e.g., pathology, outcomes data) in the context of AI/ML.
- Sample size for training sets and how ground truth for training sets was established.
However, the document does contain information about the non-clinical tests performed to demonstrate the safety and effectiveness of the device as a medical electrode. This can be interpreted as the studies done to meet the acceptance criteria for a medical electrode.
Here's a summary of what's provided related to device performance and testing:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a table of acceptance criteria in the explicit format requested for AI/ML performance metrics. Instead, it refers to compliance with established standards for medical electrodes. The "performance" is demonstrated by meeting these standards.
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|
| Biocompatibility: | |
| ISO 10993-5 (In vitro cytotoxicity) | Conforms |
| ISO 10993-10 (Irritation and skin sensitization) | Conforms |
| Electrical Property: | |
| AAMI/ANSI EC12 (Disposable ECG Electrodes) | Conforms |
| Shelf-life Testing: | |
| ASTM F1980-02 (Accelerated aging of sterile medical device package) | Conforms |
| Basic Safety and Essential Performance: | |
| AAMI/ANSI ES 60601-1:2005/(R)2012, CL 8.5.2.3 (Patient Leads) | Conforms |
| IEC 60601-1:2005 subclause 8.5.2.3 | Conforms |
| Impedance |
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).