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Luminice is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

Luminice is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. Four (4) stainless steel electrodes, fixed on the Luminice device main body, deliver low level electrical impulses (microcurrent) to targeted locations on the body. The Luminice should be used with 510(k) clearance electroconductive media gel, and it's compatible with NuFACE Gel Primer cleared under K161654.

The provided text is a 510(k) summary for the Luminice device, stating its substantial equivalence to a predicate device (NuBODY Skin Toning Device, K171588). However, this document does not contain any information about acceptance criteria, device performance results from a study, sample sizes, data provenance, expert involvement for ground truth, or MRMC studies.

The document primarily focuses on:

• Device Description: What the Luminice device is, its intended use (body skin stimulation for over-the-counter cosmetic use), and its technical specifications.
• Substantial Equivalence Comparison: A detailed comparison of the Luminice device with its predicate device (NuBODY Skin Toning Device) across various characteristics like regulation number, class, product code, intended use, anatomical sites, technological characteristics, basic unit characteristics, and output specifications.
• Non-clinical Testing: A list of international consensus standards (electrical safety, EMC, additional safety, biocompatibility, software validation) to which the Luminice device has been tested and conformed.
• Conclusion: The device is substantially equivalent to the predicate device based on similar intended uses and technological characteristics.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

The document only states that the device has passed certain non-clinical tests (electrical safety, EMC, biocompatibility, software validation) according to specific standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 10993-5, etc.). These standards define test methods and acceptance limits for specific safety and performance aspects, but the results of these tests (the reported device performance against specific numerical acceptance criteria) are not detailed here. The document also does not mention any clinical studies or studies involving human subjects, nor does it refer to multi-reader multi-case (MRMC) studies or standalone algorithm performance studies. The ground truth establishment methods for any such studies are consequently also not available.

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