(162 days)
Mailuokang Self-adhesive Electrode is intended for use as reusable, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Example electrical stimulation devices for current applications of the electrodes, but are not limited to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.
Mailuokang Self-adhesive Electrode is used as a reusable and re-positionable transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation). Mailuokang Self-adhesive Electrode is for prescription use and over-the-counter use, for single patient use only.
The provided text is a 510(k) summary for the Mailuokang Self-adhesive Electrode. It describes the device, its intended use, and compares it to a predicate device (THERATRODE, K112312) to demonstrate substantial equivalence.
Here's an analysis of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by device manufacturer or standard) | Reported Device Performance (Mailuokang Self-adhesive Electrode) |
|---|---|
| Biocompatibility: Skin irritation | Passed (Mailuokang's hydrogel has passed skin irritation test) |
| Biocompatibility: Sensitization | Passed (Mailuokang's hydrogel has passed sensitization test) |
| Biocompatibility: Cytotoxicity | Passed (Mailuokang's hydrogel has passed cytotoxicity test) |
| Electrode Contact Impedance (10 Hz, ≤100 µA p-p) | Average value for 12 electrode pairs connected gel-to-gel: ≤ 2 kilohms (kΩ). None of individual pair impedances: ≤ 3 kΩ. (Passed self-evaluation test) |
| Adhesion | Passed self-evaluation test for adhesiveness. |
| Compliance with ANSI/AAMI EC 12:2000/(R)2005 standard | Comparison testing between predicate device and subject device was performed according to this standard, and both devices passed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for impedance test: 12 electrode pairs.
- Data Provenance: The document does not explicitly state the country of origin for the impedance and adhesion self-evaluation tests. It refers to "self-evaluation tests," which implies these were conducted by the manufacturer. The biocompatibility tests are also stated as "Mailuokang's hydrogel has passed three biocompatibility tests," suggesting these were likely conducted by or for the manufacturer. The study is prospective in the sense that these tests were conducted to demonstrate equivalence for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts or ground truth established by experts for the test set. The performance tests (impedance, adhesion, biocompatibility) are objective measurements based on established standards or internal evaluations, not expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. The performance tests are objective measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not a study involving human readers or AI assistance. It's a medical device submission for an electrical stimulation electrode.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device. The device itself is a physical electrode.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by:
- Objective Measurements: Impedance values, adhesion force, and observation of biological response in biocompatibility tests.
- Compliance with Standards: Adherence to established industry standards like ANSI/AAMI EC 12:2000/(R)2005.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training" set in the context of machine learning or algorithms. Its performance is based on material properties and design, validated through direct testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set involved. The performance (ground truth) is established through physical and electrical testing of the electrodes.
§ 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).