(146 days)
Electrotherapy Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electrotherapy Electrodes are intended to be used with marketed Electrical Stimulators, (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation)) for transmitting electrical current. The electrodes are for OTC (Over-The-Counter) or Prescription use.
Electrotherapy Electrodes provide a means for establishing electrical contact between the lead connected to a TENS, EMS or NMES stimulation device and the skin, and are multi-layer, flexible structures composed of laminated materials commonly used in the application:
1st layer: Insulation material: Tan fabric
2nd layer: Double sides adhesive tape
3rd layer: Conductive film (Carbon Film)
4th layer: Self-adhesive conductive hydrogel
5th layer: Plastic release film
Connection: Leadwire/Snap button
The electrodes are designed for single-patient & single application use. Because of the adhesive nature of the conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
The provided FDA 510(k) clearance letter and summary for the Electrotherapy Electrodes (K250841) does not describe a study involving AI or human reader performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.
Therefore, many of the requested details about acceptance criteria for AI and human performance studies, expert involvement, adjudication, MRMC studies, standalone AI performance, and ground truth establishment cannot be found in this document.
However, I can extract the acceptance criteria and performance data related to the non-clinical tests that were performed to demonstrate substantial equivalence for this device.
Acceptance Criteria and Device Performance (Non-Clinical)
The device, Electrotherapy Electrodes (K250841), is a Class II cutaneous electrode. The study described focuses on demonstrating its substantial equivalence to a predicate device (ZMI Self-Adhesive Electrodes, K180865) primarily through non-clinical performance and biocompatibility testing. No AI component or human reader study is discussed.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Metric) | Acceptance Limit | Reported Device Performance (Result) | Study Description |
|---|---|---|---|
| Electrical Performance | |||
| A.C. Impedance | ≤ 160 ohms | Not explicitly stated, but "All tests were verified to meet acceptance criteria." implies it passed. | Electrical performance was evaluated under IFU (Instructions for Use) normal use conditions. This likely involved measuring the A.C. Impedance of the electrodes. The acceptance limit for the predicate device was |
§ 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).