(81 days)
Self-Adhesive Electrode is intended for as a reusable, conductive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current),or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.
Self-Adhesive Electrodes are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Comytens are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:
- Top layer: Fabric/Foam/ Tan fabric
- Middle layer: Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film)
- Bottom layer: Biocompatible self-adhesive conductive hydrogel
- Connection: Leadwire/snap button/magnetic button
- double sides adhesive tape: which is used for attaching the non-woven fabrics and conducting film
- Release liner: plastic film is a protective layer for the hydrogel.
The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
For the electrical connection, Comytens provides lead wire type and snap button/Magnetic button type.
The medical device in question is a Self-Adhesive Electrode manufactured by Guangdong Comytens Medical Technology Co.,Ltd. This device is intended for use as a reusable, conductive interface between the patient's skin and marketed electrical stimulators (e.g., TENS, EMS, IF/IFC, PGF) for transmitting electrical current, for both OTC and Prescription use.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison table between the subject device (Self-Adhesive Electrode) and a predicate device (ZMI Self-adhesive electrodes, K180865). This table implicitly defines the acceptance criteria by stating that the subject device's performance is "Same" or "similar" to the predicate, and explicitly lists some technical specifications.
| Acceptance Criteria (Measured against Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|
| Intended Use (reusable, conductive interface for electrical stimulators: TENS, EMS, IF/IFC, PGF, transmitting electrical current, OTC/Prescription use) | Same |
| OTC or Prescription Use | OTC and Prescription |
| Target Population (General [Adult]) | General [Adult] |
| Shape (compared to various shapes of predicate) | Square (40x40mm) |
| Color | White, Red, Black, and Tan |
| Regulation Number (21 CFR 882.1320) | 882.1320 |
| Product Code (GXY) | GXY |
| Classification Name (Cutaneous electrode) | Cutaneous electrode |
| Design Feature: Construction Materials (Insulation backing material, Conductive film, Conductive hydrogel) | Similar (Subject device has additional layers beyond the three basic ones mentioned for the predicate: conductive carbon fiber lead wire (or snap for Magnetic Style Electrode), double sides adhesive tape, and plastic film) |
| Electrical Connection (Leadwire, Snap button, Magnetic button) | Same |
| Lead Wire Connector (.080"/0.1" (2mm/2.5mm) female socket or Pin connector) | Similar (.080" (2mm) female socket connector for predicate, subject device lists .080"/0.1" (2mm/2.5mm) female socket or Pin connector) |
| Sterility | Non-sterile |
| Reusability | Reusable |
| Packaging | Re-sealable bag packed |
| Adhesive Type | Self-adhesive |
| Biocompatibility (Complies with ISO10993) | Complies with ISO10993 |
| A.C. Impedance (6 pounds of force) | More than 6 pounds of force |
| Single Patient Use | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes bench testing and biocompatibility testing.
- Sample Size for Bench Testing: Not explicitly stated. The document mentions "The Self-Adhesive Electrode was tested..." in several instances (e.g., for electrical & impedance, adhesion, connector & mechanical, packaging, accelerated aging), implying a sample of the manufactured device.
- Sample Size for Biocompatibility Testing: Not explicitly stated. Biocompatibility tests usually involve a defined number of samples for each test (e.g., in vitro cytotoxicity, irritation, sensitization).
- Data Provenance: The document does not explicitly state the country of origin of the data. However, the submitter is Guangdong Comytens Medical Technology Co., Ltd. from China. The testing itself is described as "Non-Clinical Data" indicating it was conducted in a controlled environment (labs) rather than on human subjects. This is prospective testing, as it's performed specifically to demonstrate compliance for regulatory submission.
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 as the device is a cutaneous electrode and the acceptance criteria are based on physical, electrical, and biological performance characteristics measured through bench testing and biocompatibility testing, not on human-interpreted data that requires expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above (bench and biocompatibility testing). Adjudication methods are typically used for clinical studies involving interpretation of medical images or outcomes where expert consensus is needed.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists interpreting images). The Self-Adhesive Electrode is a physical medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. The device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by objective measurements against recognized international and national standards.
- Bench Testing: The "ground truth" for electrical, mechanical, and adhesive properties is derived from the specifications outlined in standards (e.g., IEC60601-1, ASTM F1980) and the predicate device's established performance. The device must meet or exceed these values.
- Biocompatibility Testing: The "ground truth" for biocompatibility is whether the device material elicits a harmful biological response, as assessed by the criteria defined in ISO 10993-1 and subsequent specific tests (Cytotoxicity, Skin Sensitization, Skin Irritation). Failure to pass these tests would indicate a deviation from acceptable biological safety.
8. The sample size for the training set
This information is not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this 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).