(132 days)
Garment Electrodes are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The Garment Electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include elbow, knee or back band.
Garment Electrodes are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The Garment Electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.
The provided FDA 510(k) clearance letter and Indications for Use statement for the "Garment Electrodes" (K222863) do not contain information typically found in a study demonstrating device performance against specific acceptance criteria. This document is a regulatory clearance, not a technical report detailing performance testing.
Therefore, I cannot provide the requested information that would usually be found in a performance study, such as:
- A table of acceptance criteria and the reported device performance: This document does not describe specific performance criteria (e.g., impedance, current distribution, adhesion) or report performance metrics against them.
- Sample size and data provenance for the test set: Not available.
- Number of experts and their qualifications: Not applicable, as this is not a study requiring expert interpretation of results.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance: Not detailed.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (this is an electrode, not an AI/ML device).
- How ground truth for the training set was established: Not applicable.
What the document does tell us:
The document indicates that the Garment Electrodes are cutaneous electrodes for use with legally marketed TENS or NMES devices. They are described as non-sterile reusable OTC conductive garments intended to deliver stimulation signals.
The FDA's review determined that the device is substantially equivalent to legally marketed predicate devices. This implies that testing was done to ensure the Garment Electrodes meet the same safety and effectiveness standards as previously cleared devices of similar type, but the specific details of that testing are not disclosed in this public clearance letter. Such testing might typically involve electrical performance (e.g., impedance, current density), biocompatibility, durability, and safety aspects relevant to a cutaneous electrode.
§ 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).