(87 days)
Apex self-adhesive electrodes are intended to be used in TENS (Transcutaneous Electrical Stimulation) and NMES (NeuroMuscular Electrical Stimulation) applications.
Com-Patch, Self Adhesive Electrodes Models: AP-0981201, AP-0981203, AP-0981208, and AP-0981209
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for "Com-Patch, Self Adhesive Electrodes," which states that the device is substantially equivalent to legally marketed predicate devices.
The letter discusses:
- The device name and models
- Regulation number, name, and class
- Product codes
- The date the 510(k) was filed and received
- Confirmation of substantial equivalence based on indications for use
- Regulatory requirements and contacts for further information
It does NOT include:
- A table of acceptance criteria or reported device performance
- Sample sizes or data provenance for any test sets
- Information about experts or ground truth establishment
- Adjudication methods
- Multi-reader multi-case (MRMC) comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth used
- Sample size for training sets
- How ground truth for training sets was established
The document's purpose is to grant market clearance based on substantial equivalence, not to detail the results of performance studies against specific acceptance criteria.
§ 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).