(125 days)
The Disposable Gold Cup EEG Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electroencephalograph (EEG), electromyography (EMG), and Evoked Potentials (EP).
The EEG electrodes are provided to the healthcare provider in either a set of 10 which are typically used for sleep studies or a set of 15 which are used for EEG monitoring. Each set of electrodes are the same length, however, sets can be ordered in lengths varying from 1.0 to 3.0 meters. Each electrode within a set has a different color to aid in placement.
Here's a summary of the acceptance criteria and the study information for the Dymedix Diagnostics Disposable Gold Cup EEG Electrodes (K192564), based on the provided document:
This document is a 510(k) clearance letter, which means the device is being cleared based on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials to establish its efficacy and safety from scratch. Therefore, the "study" described focuses on bench testing and biocompatibility to show that the new device performs comparably to established devices.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Requirement | Reported Device Performance / Evidence |
|---|---|---|
| Indications for Use | Identical to predicate device: Non-invasive use with recording and monitoring equipment for EEG, EMG, and EP. | The device's Indications for Use are identical to the predicate devices. The electrodes can be used with Electroencephalograph (EEG), Electromyography (EMG), and Evoked Potentials (EP) monitoring equipment. |
| Technology & Construction | Similar to predicate device, with comparable signal collection and transmission. | The technology and construction are similar to the predicate devices, utilizing an electrode of similar shape and size to collect and transmit signals through connection wires to the monitoring device. The electrode materials are different from Daehan (silver/silver chloride vs. gold plated), but the Dymedix electrodes are identical to Technomed Europe Gold Cup Electrodes in material (gold plated brass) indicating equal or better signal sensitivity. |
| Environment of Use | Similar to predicate device: Healthcare settings where monitoring studies may be performed. | The environments of use are similar to the predicate devices: healthcare settings where monitoring studies may be performed. |
| Patient Population | Similar to predicate device: Adults and children. | The patient population is similar to the predicate devices: adults and children. |
| Biocompatibility | Meet applicable ISO 10993 standards for external communicating device with limited duration surface contact. | Biocompatibility testing performed to applicable ISO 10993 standards. Patient contacting materials are reported as non-cytotoxic, non-sensitizers, non-irritants, and non-toxic. |
| Electrical Performance | Meet the ANSI/AAMI EC12:2000/(R)2015 standard. | Electrical performance testing was performed to the ANSI/AAMI EC12:2000/(R)2015 standard, and the electrodes are reported to meet the standard. |
| Mechanical Integrity | Adequate performance throughout device use, exceeding requirements. | Performance bench testing verified the electrodes will perform adequately through the duration of use. Mechanical bond testing and surface adhesive testing demonstrate the device integrity exceeds requirements for the intended use. |
Study Details:
-
Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in terms of patient data or clinical images. The data provenance is from bench testing for electrical, mechanical, and biocompatibility properties. No specific "sample sizes" (e.g., number of electrodes tested for each bench test) are provided in this summary, which is typical for 510(k) summary documents. The testing is prospective in the sense that the manufacturer conducted these tests specifically for this submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) summary. "Ground truth" in this type of submission refers to established engineering standards (like ISO 10993 and ANSI/AAMI EC12) and the technical specifications of the predicate devices. Experts involved would be those qualified to conduct and interpret the specified standard tests (e.g., test engineers, toxicologists for biocompatibility), but their specific number and qualifications are not detailed here.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for clinical trials or image annotation, which are not described here.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This device is a passive EEG electrode and does not involve AI or human reader interpretation for its function.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a hardware component (electrode), not an algorithm or software.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating substantial equivalence relies on:
- Industry standards: ISO 10993 for biocompatibility, ANSI/AAMI EC12:2000/(R)2015 for electrical performance.
- Predicate device specifications: The technical characteristics, indications for use, and performance of the legally marketed predicate devices (K180232 Daehan Disposable CUP Electrodes and K072016 Technomed Europe Cup Electrodes).
- The "ground truth" for demonstrating substantial equivalence relies on:
-
The sample size for the training set:
- Not applicable. There is no "training set" as this is a hardware device, not an AI/ML algorithm requiring data for training.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set.
§ 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).