(124 days)
Jmoon Conductive Gel is intended to be used with microcurrent devices to improve skin conductivity.
The Jmoon Conductive Gel is a clear, viscous and chloride-free formulation. The gel is to be applied to the area under an electrode to reduce the impedance of the contact interface between the electrode surface and the skin.
The provided FDA 510(k) clearance letter and summary for the Jmoon Conductive Gel do not contain any information regarding clinical studies with human participants or the use of AI/algorithms. The document primarily focuses on the device's substantial equivalence to a predicate device based on its physical, chemical, and biological characteristics, as well as biocompatibility and shelf-life testing.
Therefore, many of the requested categories cannot be populated from the provided text.
Here's a breakdown of the available information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study that Proves Acceptance Criteria |
|---|---|---|
| Intended Use | Jmoon Conductive Gel is intended to be used with microcurrent devices to improve skin conductivity. | Performance of the device characteristics (physical, chemical, biological) were evaluated. The conclusion states that the subject device is substantially equivalent to the predicate device for its intended use. |
| Target Population | Adults 18 years of age or older | Not explicitly tested, but matches predicate device. |
| Environment of Use | Home | Not explicitly tested, but matches predicate device. |
| Body Contact | Intact skin | Biocompatibility testing (ISO 10993-1, -5, -10, -23) |
| Conductive Material | Sodium Salt | Performance testing (conductivity) |
| Sterilization | Non-sterile | Not applicable (matches predicate) |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23 | Biocompatibility Testing (ISO 10993-5: In Vitro Cytotoxicity, ISO 10993-10: Skin Sensitization, ISO 10993-23: Irritation) |
| Chemical Safety | Non-OSHA PEL | Chemical Safety testing (not detailed, but stated as compliant) |
| pH | 5.0 ~ 7.0 | Performance testing (pH) |
| Shelf-life | 3 years | Accelerated stability testing (3 years) |
| Physical Characteristics | Meets intended specification | Performance testing (appearance, color, odor, viscosity) |
| Microbiological Growth | Meets intended specification | Performance testing (microbiological growth) |
Study Details Based on Provided Information:
- Sample size used for the test set and the data provenance: Not applicable. The studies mentioned (biocompatibility, shelf-life, performance testing) refer to laboratory-based evaluations of the gel's properties, not clinical studies with a test set of human subjects or images.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This information is relevant for studies involving human interpretation or clinical outcomes, which are not present in this document.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human interpretation requiring adjudication was involved.
- 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. The device is a conductive gel, not an AI-based diagnostic or assistive tool.
- 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 type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device would be established through laboratory standards and validated test methods for chemical, physical, and biological properties, as well as regulatory standards for biocompatibility (e.g., ISO 10993 series).
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable. No training set was used.
§ 882.1275 Electroconductive media.
(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).