(278 days)
The proposed device is intended for use as the disposable, conductive adhesive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators. i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for OTC use.
The proposed TENS Electrodes are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The proposed device mainly consists of electrode pad and wire. The electrode pad is available in rectangular shape, round shape, and butterfly shape, etc.
The Cathay Manufacturing Corp. TENS Electrodes (K160081) were compared against a primary predicate device (K080276) and a reference device (K132588) to establish substantial equivalence. The study involved bench testing (non-clinical) to assess performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test) | Acceptance Criteria (Threshold) | Reported Device Performance (K160081) |
|---|---|---|
| Performance Standard | Conforms to IEC 60601-1 and IEC 60601-2-10:2012 | Conforms to IEC 60601-1 and IEC 60601-2-10:2012 |
| Electrical impedance | Individual pad impedance below 200 ohms @ 60 kHz (for K160081). For predicates, "Pass if the needle of multi-meter moves" for x1k ohm range. | Met: Individual pad impedance below 200 ohms @ 60 kHz. (Also passed predicate test method). |
| Adhesive performance on steel ball | >= No.14 steel ball (Diameter: 11.112 mm) following AS07-003 / GB/T4852-2002 | Met: >= No.14 steel ball (Diameter: 11.112 mm) |
| Adhesive holding strength | A sample pad with 25mm length and 25 mm width; Hang a weight of 200g without detach within 30s | Met: Successfully held 200g weight for at least 30s. |
| Tensile Strength | Electrode is held up with a weight of 500g hung on the wire, and can hold on at least 1 minute | Met: Successfully held 500g weight for at least 1 minute. |
| Conformability | No more than 10% of the adhesive area of the device shall have separated from the skin surface at 1 h after application. | Met: No more than 10% separation after 1 hour. |
| Impedance Distribution uniformity | 1) No significant deviation between resistance values measured for each combination mode. |
- Maximum and minimum values within ±10% of average value. | Met: No significant deviation; max/min values within ±10% of average. |
| Stability and shelf life | 2 year | 2 year (demonstrated to be equivalent) |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes (number of electrodes) used for each individual performance test (e.g., electrical impedance, tensile strength) on the subject device. It mentions "Largest model: CM100180FC (Rectangle shape: 100 x 180 mm); Smallest model: CM2222FC (square shape: 22 x 22 mm); Irregular representative: CM2542YC(crescent )" were used for testing electrode types, shapes, and sizes. This suggests at least one of each representative size and shape were included.
The data provenance is not specified beyond being "bench testing (non-clinical)." There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable as the study described is a non-clinical bench testing study of TENS electrodes, not a study involving human-in-the-loop performance or expert interpretation of diagnostic images/data. Therefore, there was no ground truth requiring expert establishment.
4. Adjudication Method:
This section is not applicable for the same reasons as above. There was no expert review or adjudication of results required for this type of non-clinical bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not applicable to TENS electrodes' physical and electrical performance evaluation.
6. Standalone Performance Study:
Yes, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was done, but not for an AI algorithm. The "algorithm" in this context refers to the device itself and its intrinsic performance as measured by various physical and electrical tests. The bench testing evaluated the device's performance directly against the defined acceptance criteria without human interaction influencing the measurement results.
7. Type of Ground Truth Used:
The "ground truth" for this study was based on objective, quantitative measurements and established industry standards (e.g., IEC 60601-1, IEC 60601-2-10:2012, AS07-003 / GB/T4852-2002). The results of the tests (e.g., resistance values, weight held, adhesion percentage) served as the direct evidence of performance against these pre-defined benchmarks.
8. Sample Size for the Training Set:
This section is not applicable. The device in question is a physical medical device (TENS electrodes), not an AI algorithm that requires a training set. The "design" and "validation" mentioned relate to engineering and manufacturing processes, not machine learning model training.
9. How the Ground Truth for the Training Set was Established:
This section is not applicable for the same reason as above. There was no training set for an AI algorithm.
§ 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).