(389 days)
To conduct electrical stimulation to a patient's skin.
Single patient use.
Repositionable, self-adhering.
Over the counter use.
The electrode is used in conjunction with electrical stimulating therapy for the symptomatic relief and management of chronic pain or some types of acute pain, muscle stimulation therapy for the relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion.
The device provides a means for establishing electrical contact between the lead connected to a TENS, FES, or NMES stimulation device and the skin. The device consists of conductive hydrogel, a conductive lead wire, a non-conductive cloth backing material with a printed conductor on the side contacting the hydrogel.
The provided document describes the acceptance criteria and the study conducted to prove that TENS/FES/NMES electrodes meet these criteria.
Here's the breakdown as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Impedance Levels (at 1K-Hz) | "comparable to all the legally marketed electrodes identified above [Medtronic ComfortEase (K851303), and the 3M Myocare (K905539) Muscle Stimulation Electrodes]." |
| Skin Sensitivity | "passed the required skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the impedance or skin sensitivity testing.
The provenance of the data is from Uni-Patch internally, comparing their electrodes to existing legally marketed devices. It appears to be prospective testing conducted by Uni-Patch to support their 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for impedance was established by direct measurement and comparison to similar devices, not by expert consensus on interpretations. For skin sensitivity, the "Tripartite Biocompatability Guidance for Medical Devices" sets the standard, which is a regulatory guideline, not expert consensus on individual cases.
4. Adjudication Method for the Test Set
Not applicable, as the acceptance criteria were based on quantitative measurements (impedance) and compliance with established biocompatibility guidelines. There was no need for an adjudication method as would be used for subjective assessments.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The evaluation focused on the technical performance characteristics of the device itself (impedance and biocompatibility) rather than how human readers' performance might improve with AI assistance. This device is an electrode, not an AI-powered diagnostic tool.
6. If a Standalone Performance Study Was Done
Yes, a standalone performance study was done for the device. The reported impedance levels and skin sensitivity test results reflect the performance of the Uni-Patch electrodes themselves, independent of any human interaction beyond the application of the electrode for testing.
7. The Type of Ground Truth Used
- Impedance: The ground truth was established by comparing the measured impedance values of the Uni-Patch electrodes to the measured impedance values of "legally marketed electrodes" (Medtronic ComfortEase and 3M Myocare) which are presumed to be safe and effective based on their prior approval.
- Skin Sensitivity: The ground truth was established by conformance to "Tripartite Biocompatability Guidance for Medical Devices," which provides established criteria for biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This device is an electrode, not a machine learning algorithm, therefore there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
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).