(602 days)
The Conductive Silicone Electrode is intended to be used with legally marketed electrical stimulation devices such as transcutaneous electrical nerve stimulators. Conductive Silicone Electrode will deliver the stimulation signals generated by the stimulator to the surface where it is in contact with.
Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode)
I am sorry, but the provided text from the FDA 510(k) clearance letter for the "Conductive Silicone Electrode" (K221199) does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The document is a clearance letter, which means the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as:
- Device Name: Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode)
- Regulation Number and Name: 21 CFR 882.1320, Cutaneous electrode
- Regulatory Class: Class II
- Product Code: GXY
- Indications for Use: The Conductive Silicone Electrode is intended to be used with legally marketed electrical stimulation devices such as transcutaneous electrical nerve stimulators and will deliver the stimulation signals generated by the stimulator to the surface where it is in contact with.
- Type of Use: Over-The-Counter Use
- General Controls Provisions: Mentions annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration, Quality System (QS) regulation, medical device reporting, etc.
The letter explicitly states that "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."
Therefore, I cannot provide the requested information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications because this information is not present in the provided FDA clearance letter. Such details would typically be found in the 510(k) summary or the full premarket notification submission, which is not included here.
§ 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).