(86 days)
The Adhesive Electrodes are intended for use as a reusable, conductive interface between the patient's skin and the marketed electrical stimulators i.e. TENS (Transutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.
Adhesive Electrodes are composed of non-woven fabric, carbon film coated with silver and conductive hydrogel; It is identical in technological characteristics compared to the predicate device, Adhesive Electrodes, OACWN serial cleared in K160138 and the subject devices are also to be sold for over-the-counter (OTC) use and prescription use, which is the same as the predicate device.
Adhesive Electrodes manufactured by Voncare Medical Device Co., Ltd are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application.
First layer: Insulating backing material-nonwoven coated with 30-50um bio-compatible medical adhesive tape
Second layer: Conductive film
Third layer: Bio-compatible self-adhesive conductive hydrogel, thickness 1.0+/-0.2mm
Protective silicon liner: PET
The electrodes are designed for single-patient/multiple application use. Because of the biocompatible conductive hydrogel's adhesive nature, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" female socket connector. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly complies with FDA performance standard 21 CFR Part 898.
The provided text describes the regulatory clearance (K212191) for "Adhesive Electrodes" manufactured by Voncare Medical Device Co., Ltd. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, the study details are primarily related to non-clinical performance and safety testing.
Here's a breakdown of the requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) | Difference Discussion |
|---|---|---|---|
| A.C. Impedance | 6 pounds of force | >7 pounds of force | The difference does not raise any new questions of safety and effectiveness which meet the design requirement. |
| Biocompatibility | Complies with ISO10993 | Complies with ISO10993 | Identical |
| Sterility Status | Non-sterile | Non-sterile | Identical |
| Single Patient Use | Single Patient Use | Single Patient Use | Identical |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the sample size for individual tests. It states that "Non-clinical tests were conducted."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the tests were retrospective or prospective. Given that the manufacturer is based in China, it's highly probable the testing was conducted there or overseen by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided in the document. The tests performed are non-clinical (e.g., electrical impedance, mechanical strength, biocompatibility), which rely on standardized measurement methods rather than expert interpretation of a "ground truth" in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies involving human interpretation or challenging endpoints.
5. 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 conducted. The device is an adhesive electrode, a passive component, not an AI-powered diagnostic or assistive tool for human readers. The document explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an adhesive electrode, not an algorithm, and does not involve AI or standalone performance in the context of diagnostic or interpretive tasks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is defined by the applicable standards requirements (e.g., ANSI/AAMI ES60601-1 for safety/performance, ISO10993 for biocompatibility) and the predicate device's performance characteristics. The tests verify that the subject device meets these established performance and safety benchmarks.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm and therefore does not have a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm and therefore does not have a 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).