(199 days)
The Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is indicated for use with transcutaneous electrical stimulation devices to provide the conductive interface between the stimulation device and the patient's skin.
The Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode is a transcutaneous electrical nerve stimulation (TENS), neuromuscular electrical stimulation (NMES), functional electrical stimulation (FES) electrode. It is composed of a cover, reinforcement film, lead wire, glue, silver print, conductive member, conductive hydrogel, pressure sensitive adhesive, and a release liner. During electrotherapy, current from the electrical stimulation device is delivered through the lead wire, silver printed conductive member, conductive hydrogel, and to the patient's skin. Four finished electrodes are placed into a protective pouch. The pouches are sealed and boxed for shipping.
This device, the Superior Starburst Reusable Self-Adhering TENS/NMES/FES Stimulating Electrode, did not require performance data or a study to demonstrate its effectiveness or safety for its intended use, as stated in the submission. The acceptance was primarily based on a change to product labeling for Over-The-Counter (OTC) use, affirming its substantial equivalence to a predicate device.
Given this, the requested information elements for acceptance criteria and a study proving device performance are largely not applicable in the traditional sense for this specific 510(k) submission.
Here is an attempt to address your request based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document explicitly states "No performance data was required to support this premarket notification." Therefore, there are no specific quantitative acceptance criteria or reported device performance metrics from a formal study within this submission. The "acceptance" was based on substantial equivalence and a change in labeling for OTC use.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Technological Characteristics Substantial Equivalence to Predicate Device (K083350) | The proposed OTC device exhibits identical technological characteristics, including design and materials, as compared to the currently marketed predicate prescription device. |
| Safety and Effectiveness for OTC Use (Implicit) | Deemed substantially equivalent to a predicate device already determined safe and effective for prescription use, and suitable for OTC use based on labeling evaluation. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new performance testing or clinical study with a test set was conducted for this 510(k) submission. Acceptance was based on substantial equivalence to a predicate device and a change in labeling.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No new test set or ground truth establishment by experts was required for this submission.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication was used for this submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrode, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. No new ground truth was established for this submission. The underlying "ground truth" for the device's safety and effectiveness would have been established during the original clearance of the predicate device (K083350), which is not detailed in this document.
8. The Sample Size for the Training Set
Not applicable. This device is an electrode, not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is an electrode, not an AI/ML algorithm.
§ 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).