(46 days)
Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
EVERLIFE, Various Models of Self Adhesive Electrodes, AP series
The provided text is a 510(k) summary for the EVERLIFE Self Adhesive Electrodes. This document primarily focuses on establishing substantial equivalence to a predicate device based on intended use and existing safety/effectiveness data for similar products. It does not contain information about a study proving specific performance acceptance criteria for the EVERLIFE electrodes.
Therefore, many of the requested elements for describing an acceptance criteria study cannot be found in the provided text.
Here is an analysis of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria for the electrical performance (e.g., impedance levels, signal-to-noise ratio) of the EVERLIFE Self Adhesive Electrodes, nor does it report specific device performance data against such criteria.
The closest to "acceptance criteria" are the biocompatibility tests performed, which are inherently "pass/fail" or "meet standard X" criteria.
| Acceptance Criteria (related to biocompatibility) | Reported Device Performance |
|---|---|
| Biocompatibility Testing: | |
| - Cytotoxicity study (ISO 10993-5) | Performed |
| - Skin irritation study (ISO 10993-10) | Performed |
| - Skin sensitization study (ISO 10993-10) | Performed |
The summary states, "the effect of impedance levels for the intended situations is assured for both of the devices, and the safety and effectiveness hazards are not present." This is a qualitative statement about performance relative to the predicate, but it does not specify quantitative acceptance criteria or report measured impedance levels.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No performance study data is presented for the EVERLIFE electrodes related to signal recording or electrical stimulation. The biocompatibility tests, while involving samples, do not align with a "test set" in the context of diagnostic or AI device performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This information is relevant for studies establishing ground truth, typically in AI/diagnostic imaging, which is not the subject of this 510(k) submission.
4. Adjudication Method
Not applicable. No expert-based adjudication process is described in the context of device performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not pertain to an AI-assisted diagnostic device, and therefore, an MRMC study is not relevant or mentioned.
6. Standalone (Algorithm Only) Performance
No. This device is a medical accessory (electrodes), not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" here is implied by the successful completion of the biocompatibility tests according to ISO standards, and the claim of substantial equivalence based on the predicate device's established safety and effectiveness. For the biocompatibility, the "ground truth" would be the standard biological reactions or lack thereof as defined by the ISO guidelines.
8. Sample Size for the Training Set
Not applicable. This device does not involve a "training set" as it is not an AI or machine learning product.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this information is irrelevant.
In summary, the provided 510(k) document is for a medical accessory (self-adhesive electrodes) and primarily relies on substantial equivalence to a legally marketed predicate device, along with successful biocompatibility testing. It does not describe a performance study with quantitative acceptance criteria, test sets, or expert-adjudicated ground truth as would be seen for a diagnostic or AI-driven device.
§ 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).