(198 days)
The NuFACE Gel Primer is intended to be used with NuFACE microcurrent devices to improve skin conductivity.
The NuFACE Gel Primer 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 text is a 510(k) summary for the NuFACE Gel Primer, a medical device. This type of document is a premarket submission made to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. While it contains information about testing and compliance, it does not describe a study that uses human experts to establish ground truth or compare AI performance, as typically found in studies for AI/ML-based medical devices.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.
However, I can extract information related to the device's acceptance criteria and the performed performance testing.
Acceptance Criteria and Reported Device Performance
| Criteria | Reported Device Performance | Comments |
|---|---|---|
| Intended Use | "The NuFACE Gel Primer is intended to be used with NuFACE microcurrent devices to improve skin conductivity." | Equivalent to predicate (Thera-Cream) |
| Environment of Use | Home | Same as predicate |
| Intended User | Adults 18 years of age or older | Equivalent to predicate (Adults) |
| Where Used | Topically on intact skin | Same as predicate |
| Conductive Material | Salt (Magnesium Sulfate) | Equivalent to predicate (Conductive Copper Salts) |
| Sterilization | Non-sterile | Same as predicate |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, and ISO 10993-10 | Same as predicate (Complies with ISO 10993-1, ISO 10993-5, and ISO 10993-10) |
| Chemical Safety | Non-OSHA PEL | Same as predicate |
| Volume or Weight | 2 fl. oz. and 5 fl. oz. tube | Equivalent to predicate (4.2 fl. oz. tube) |
| Physical, Chemical & Biological Characteristics | Meets established specifications for color, odor, appearance, pH, microbiological growth, specific gravity and viscosity. | All tests demonstrate compliance. |
| Conductivity | Meets established specifications. | All tests demonstrate compliance. |
| Packaging Compatibility | Meets established specifications. | All tests demonstrate compliance. |
| Stability | Meets established specifications. | All tests demonstrate compliance. |
Study Details (based on available information):
- Sample sized used for the test set and the data provenance: Not applicable. The document discusses device characteristics and performance testing internally, not on a "test set" of patient data for AI evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant for this device.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML device, so such a study is not relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
- The type of ground truth used: For the physical, chemical, and biological characteristics, the "ground truth" or reference is established specifications and industry standards. For biocompatibility, the ground truth is compliance with ISO 10993 standards and negative results for cytotoxicity, irritation, and sensitization. These are not 'ground truth' in the context of an AI study (e.g., pathology report, clinical outcome).
- The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML product.
- How the ground truth for the training set was established: Not applicable.
Summary of the device proving it meets the acceptance criteria:
The NuFACE Gel Primer's acceptance criteria are primarily based on its physical, chemical, and biological characteristics, its performance in improving skin conductivity, and its biocompatibility. The study that proves the device meets these criteria involved a series of performance tests:
- Physical, chemical and biological characteristics: The gel was tested for color, odor, appearance, pH, microbiological growth, specific gravity, and viscosity. The document states that "The test results demonstrate that the NuFACE Gel Primer meets the established specifications."
- Conductivity: The gel's ability to improve skin conductivity was tested. "The test results demonstrate that the NuFACE Gel Primer meets the established specifications."
- Biocompatibility: This was a critical aspect, evaluated according to ISO 10993-1. Specific tests included:
- In vitro Cytotoxicity: ISO 10993-5
- Skin Sensitization: ISO 10993-10
- Skin Irritation: ISO 10993-10
All biocompatibility testing was performed in accordance with CFR 21 Part 58 Good Laboratory Practice (GLP) and "The test results demonstrate the NuFACE Gel Primer is biocompatible when used as intended."
- Packaging compatibility: Tested to ensure the gel remains stable and effective within its packaging. "The test results demonstrate that the NuFACE Gel Primer meets the established specifications."
- Stability: Tested to confirm the product's integrity and performance over time. "The test results demonstrate that the NuFACE Gel Primer meets the established specifications."
The conclusion explicitly states: "Based on the results of the performance tests and the biocompatibility evaluation, NuFACE Gel Primer is substantially equivalent to the predicate device in safety." This indicates that meeting these established specifications and demonstrating biocompatibility are the primary means by which the device proves it meets its acceptance criteria for safety and effectiveness, especially in comparison to its predicate device.
§ 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).