(147 days)
The self-adhesive electrode is intended to be used to apply electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS (Transcutaneous Electrical Nerve Stimulation) EMS (Electrical Muscular Stimulation)
Jiajian branded Self-adhesive Electrodes, wire type, are non-sterile flexible structures, composed of materials commonly used in this application: First layer: Nonwoven fabric tape Second layer. Electrically conductive carbon cloth (ValueTrode® Carbon, K970426) Third layer: Biocompatible conductive hydrogel coupling media (ValueTrode GEL, K970426), which has passed the required skin sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specifeid in ISO ISO 10993-5. The electrodes are designed for single patient / multiple application use. It can be used for low-frequency or medium-frequency nerve or muscle stimulators, as the conduction film adhered to body skin. There are six shapes of round, rectangle, oval, gourd, butterfly and saddle of the electrodes. For the electrical connection, Jianjian provides wire type: Lead wire assembly - at least 40mm long wire with 2.5mm diameter female socket, connected to one side of the wire. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR Part 898 by testing under IEC 60601-1. subclause 56.3(c).
This document is a 510(k) Premarket Notification for the Jiajian Self-adhesive Electrode. It's a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, not a study reporting on specific acceptance criteria and device performance in the way a clinical trial or detailed engineering report would.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be directly extracted from this document, as this type of information is generally NOT part of a 510(k) summary for this class of device.
510(k) submissions for devices like a self-adhesive electrode typically focus on demonstrating substantial equivalence in terms of:
- Intended Use: The purpose of the device.
- Technological Characteristics: How the device works and its materials.
- Performance Data: This usually involves non-clinical bench testing (e.g., biocompatibility, electrical performance, adhesive strength) to show it meets recognized standards or performs similarly to the predicate. It does not typically involve extensive clinical trials or human-in-the-loop studies.
- Biocompatibility: Showing materials are safe for human contact.
Based on the provided text, here's what can be gathered, addressing the spirit of your request where possible, and noting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not provide a table of quantitative acceptance criteria with corresponding performance data in the way you might expect from a detailed validation report. Instead, it relies on demonstrating compliance with recognized standards and similarity to predicate devices.
| Acceptance Criteria (Implied by Standards/Predicate) | Reported Device Performance |
|---|---|
| Material Biocompatibility: | |
| - Skin sensitivity testing criteria (ISO 10993-10) | - Biocompatible conductive hydrogel coupling media (ValueTrode GEL, K970426) passed the required skin sensitivity testing criteria as specified in ISO 10993-10 |
| - Cytotoxicity testing criteria (ISO 10993-5) | - Biocompatible conductive hydrogel coupling media (ValueTrode GEL, K970426) passed the required cytotoxicity testing criteria as specified in ISO 10993-5 |
- Both (predicate and proposed) were established biocompatibility on standards of ISO 10993-5-1999: Tests for cytotoxicity: In vitro methods; ISO 10993-10: 2002: Tests for Irritation and Sensitization. |
| Electrical Lead Wire Conformity: | |
| - FDA performance standard 21 CFR Part 898 | - Lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR Part 898 by testing under IEC 60601-1. subclause 56.3(c). - Both predicate 2 and proposed device lead wires conform to FDA 21 CFR Part 898. |
| Electrical Current Distribution: | - Both (predicate 1 and proposed) electrodes distribute electrical current evenly. (This is a qualitative statement of similarity, not a measured performance against a specific criterion). |
| Impedance and Adhesive Testing: | - Predicate 2 and proposed device are safe and effective by impedance and adhesive testing. (This indicates that such testing was performed, but specific values or criteria are not detailed in this summary). |
| Intended Use: (Applying electrical stimulation current) | - The device is intended to be used to apply electrical stimulation current to the patient's skin. (Demonstrated through similarity to predicate devices with the same intended use). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified in this 510(k) summary. For devices of this nature, testing typically involves bench-top studies on a certain number of manufactured units rather than large clinical test sets with human subjects.
- Data Provenance: Not explicitly stated as "country of origin" for tests, but the manufacturer is Wuxi Jiajian Medical Instrument Co., Ltd in China. The testing itself is referenced against international standards (ISO, IEC) and FDA regulations. It is not specified if tests were retrospective or prospective, but typically bench testing would be considered prospective for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Experts and Qualifications: Not applicable/not specified in this type of 510(k) submission. "Ground truth" in the clinical imaging or diagnostic sense is not relevant for this device. The assessment is primarily based on engineering and biocompatibility testing against established standards.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/not specified.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, this type of study is not relevant or reported for a self-adhesive electrode. An MRMC study is typically for evaluating diagnostic imaging devices or AI algorithms that assist human readers in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a passive electrode, not an algorithm.
7. The Type of Ground Truth Used:
- Ground Truth: For this device, "ground truth" equates to established international standards (ISO 10993, IEC 60601) and FDA regulations (21 CFR Part 898) for biocompatibility, electrical performance, and safety. The device's performance is measured against the requirements of these standards.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This device is not an AI algorithm that requires a training set. The "design" or "development" of the product is distinct from machine learning training.
9. How the Ground Truth for the Training Set was Established:
- Training Set Ground Truth Establishment: Not applicable, as there is no training set for this device.
§ 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).