(18 days)
The EZ-STIK Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The EZ-STIK Electrodes are designed and intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscle Stimulation), IF (Inferential), or PGF (Pulsed Galvanic Stimulation). The electrode is for OTC (Over-the-Counter) or Prescription Use.
EZ-STIK Electrodes have a basic 3-layer construction of non-woven polyester material or soft PVC foam, carbon film coated with silver and conductive hydrogel. EZ-STIK Electrodes are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application.
First layer: Insulating backing material- non-woven polyester material or soft PVC foam coated with biocompatible medical adhesive tape
Second layer: Conductive carbon-carbon film or Carbon film/Carbon film coated with silver film
Third layer: Biocompatible self-adhesive conductive hydrogel
The electrodes are designed for single-patient/multiple application use. Because of the biocompatible conductive hydrogel's adhesive nature, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" female socket connector. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly complies with FDA performance standard 21 CFR Part 898.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria, as it would be relevant to an AI/ML medical device.
The document is an FDA 510(k) clearance letter for a medical device called "EZ-STIK Electrodes," which are cutaneous electrodes. The content primarily discusses:
- The FDA's determination of substantial equivalence for the EZ-STIK Electrodes to legally marketed predicate devices.
- Regulatory information regarding the device (classification, product code, general controls).
- Indications for Use for the EZ-STIK Electrodes.
- A 510(k) Summary, including applicant/correspondent details, device names, predicate devices, and a description of the device's construction and intended use.
- A comparison of the subject device's indications for use and technology to predicate devices.
- Summary of non-clinical tests (biocompatibility, electrical performance, pull/peel test, shelf-life test) performed to support substantial equivalence. It explicitly states, "No clinical data were necessary for this submission."
The information you are asking for (acceptance criteria for an AI/ML device, details about ground truth, expert consensus, MRMC studies, training/test set sample sizes, etc.) is not present in this document because the EZ-STIK Electrodes are a physical medical device (electrodes), not an AI/ML-based diagnostic or imaging device.
Therefore, I cannot generate the table or answer the specific questions about AI/ML device performance and validation studies based on the provided text.
§ 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).