(87 days)
Wandy Self-adhesive Electrode is intended to transmit electrical current to patient skin, for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications, for OTC (Over-The -Counter) or Prescription use. The Electrode are used for adults only.
Wandy Self-adhesive Electrode is intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications, for OTC (Over-The -Counter) or Prescription use. The Electrode are used for adults only.
The Wandy Self-adhesive Electrodes transmits electrical current to patient skin, the electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin.
The Wandy Self-adhesive Electrodes is used as an accessory with the TENS or EMS device units.
The provided text describes a 510(k) submission for "Wandy Self-adhesive Electrodes" and focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML device requiring complex acceptance criteria and a detailed study proving performance against those criteria. Therefore, many of the requested categories are not applicable to this submission.
Here's an analysis based on the provided text, highlighting what is available and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Impedance | Passed self-evaluation tests for Impedance. |
| Wire pull | Passed self-evaluation tests for Wire pull. |
| Adhesiveness | Passed self-evaluation tests for adhesiveness. |
| Substantial Equivalence | Deemed substantially equivalent to predicate devices (K002219, K002227, K090198). |
| Safety & Effectiveness | No new questions of safety or effectiveness raised by differences to predicates. |
| Clinical Experience (Predicate) | Thousands of marketing clinical experience with predicate devices without adverse events. |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable (N/A). The submission does not describe a test set or data provenance in the context of an AI/ML device evaluation. The evaluation was based on self-evaluation tests (bench testing) and comparison to existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- N/A. This information is not relevant to the type of device and evaluation described.
4. Adjudication Method for the Test Set
- N/A. No test set or expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- N/A. This is not an AI/ML device; therefore, no MRMC study with AI assistance was conducted.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- N/A. This is a physical medical device (electrodes), not an algorithm.
7. The Type of Ground Truth Used
- For the self-evaluation tests (Impedance, Wire pull, Adhesiveness), the "ground truth" would be established by engineering specifications and standards for these physical properties.
- For the substantial equivalence claim, the "ground truth" is the performance and safety profile of the predicate devices, which have "thousands of marketing clinical experience and didn't have adverse events occurred in the world."
8. The Sample Size for the Training Set
- N/A. This is not an AI/ML device; there is no training set in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- N/A. There is no training set for an AI/ML model. The comparable information is how the performance of the predicate devices (which serve as the basis for comparison) was established, which is through extensive clinical experience.
§ 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).