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JMOON NouvelleSkin facial toning device is intended for facial stimulation and indicated for overthe-counter cosmetic use.
JMOON NouvelleSkin facial toning device is an over-the-counter device that emits energy in the red and near-infrared spectrum, designed for the treatment of facial wrinkles.

Jmoon NouvelleSkin Facial Toning device is an at-home handled device that provides an advanced, easy-to-use and efficient solution for better facial wellness. This device includes microcurrent, red and infra-red light LED, which allow you to customize your treatments according to your face skin. The device provides indicator lights and beeps feedback to guide the user during the treatment cycle.
The microcurrent therapy will deliver 3 different low-level electrical microcurrent impulses on face within a few minutes to complete facial stimulation. The red light and infra-red therapy is a treatment that uses red light to reportedly improve your skin's appearance, like reducing wrinkles.

The provided text describes a 510(k) premarket notification for the JMOON NouvelleSkin Facial Toning Device. The submission aims to demonstrate substantial equivalence to predicate devices, rather than proving performance against specific acceptance criteria through a clinical study with real-world data and expert adjudication. Therefore, much of the requested information (like sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, and ground truth for training set) is not applicable or not present in the provided document.

However, the document does contain "acceptance criteria" in the form of conformance to various safety and performance standards for non-clinical testing.

Here's the breakdown of the information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this device are its conformance to recognized safety and performance standards. The reported performance is that the device "Conforms" to these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
The testing performed was non-clinical (lab bench testing). Therefore, there is no "sample size for the test set" in the context of human subjects or clinical data, nor is there data provenance in terms of country of origin or retrospective/prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical test data was used, no experts were needed to establish ground truth for a test set based on human subjects. The acceptance criteria were based on adherence to international technical standards, which are established by expert consensus in regulatory and technical bodies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set with human subject data requiring adjudication was used.

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. No MRMC study was conducted, as the device is not an AI-assisted diagnostic or interpretive tool, and no clinical studies were performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable to this device, which is a physical facial toning device. However, the non-clinical testing evaluates the device's standalone physical, electrical, and biocompatibility performance against specified standards. The results indicate that the device "Conforms" to these standards in a standalone capacity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical testing is compliance with the specified international standards (e.g., IEC 60601-1, ISO 10993 series). These standards represent an expert consensus on safety and performance requirements for medical devices.

8. The sample size for the training set

Not applicable. The device is not based on a machine learning algorithm; therefore, there is no "training set" in the conventional sense of AI/ML development.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

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