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ZMI Self-adhesive electrodes are intended for use 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 (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrodes are for OTC (Over-The-Counter) or Prescription use.

ZMI Self-adhesive 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, reusable, flexible structures composed of laminated materials commonly used in the application:

Top laver: Insulation material: Fabric/foam/tan fabric
Middle layer: Conductive film (Silver coated Carbon film/Aluminum foil film)
Bottom layer: Biocompatible self-adhesive conductive hydrogel
Connection: Leadwire/snap button/magnetic button

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.

The provided document, a 510(k) Premarket Notification for ZMI Self-Adhesive Electrodes (K180865), is a regulatory submission to the FDA. It does not describe studies proving a device meets acceptance criteria for an AI/ML medical device. Instead, it demonstrates substantial equivalence to predicate devices for a physical medical electrode.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set details) as it is not present in the document. The document focuses on material composition, intended use, and physical/electrical performance tests relevant to an electrode, not on studies involving AI/ML algorithms, image analysis, or human reader performance.

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