(121 days)
The GMDASZ TENS Electrodes are intended for use as a reusable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. GMDASZ's reusable electrodes are designed and 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). The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin.
GMDASZ TENS electrodes are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application (Refer to attached BOM): First layer—insulating backing material: Fabric, foam or tan fabric Second layer—Conductive plastic film Third Layer – Biocompatible self-adhesive conductive hydro gel Protective liner-PET. The electrodes are designed for single-patient/ multiple application use. Because of the adhesive nature of the biocompatible conductive hydro gel, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the stimulating device by lead wire, with a standard .080" recessed female terminal with insulating outer jacket. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages as required in IEC60601-1 Subclause 56 3(c). Wire assembly is incompliance with FDA performance standard 21 CFR Part 898.
The provided text describes a 510(k) summary for GMDASZ TENS Electrodes, which is a regulatory submission to the FDA. It does not contain a study that establishes performance criteria or tests the device against those criteria. The document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The provided document is a regulatory submission for a simple medical device (TENS electrodes), and such submissions typically rely on established standards and substantial equivalence to already cleared devices, rather than comprehensive clinical performance studies involving AI or complex outcome measures.
§ 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).