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The Facial Spa is intended for the stimulation of healthy facial skin.
The Facial Spa is indicated for facial stimulation for over-the-counter cosmetic use.

The Facial Spa is a hand-held, battery-powered device used with conductive treatment gel to stimulate the face with microcurrents.

Here's a breakdown of the acceptance criteria and study information for the Nu Skin Facial Spa, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission is for substantial equivalence, meaning the device does not have explicit "acceptance criteria" for performance in the typical sense of a novel device. Instead, the "acceptance criteria" are compliance with relevant standards and demonstrating equivalence to a predicate device. The "reported device performance" is a direct comparison of its technical specifications to the predicate.

Note on "Meets Criteria?": For 510(k)s, "meeting criteria" often means being acceptably similar or having differences that don't raise new questions of safety or effectiveness. The FDA conclusion states that the technological differences do not raise new questions of safety or effectiveness, thus deeming it substantially equivalent.

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of clinical performance or algorithm evaluation with a specific sample size. This is a 510(k) submission based on substantial equivalence to a predicate device, primarily through engineering and technical comparisons and compliance with recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The submission focuses on technical specifications and adherence to safety standards, not on evaluating diagnostic accuracy requiring expert consensus on a test set.

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

Not applicable. There is no mention of a test set requiring adjudication in this 510(k).

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. This device is a transcutaneous electrical nerve stimulator for cosmetic facial stimulation, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a hardware device, not an algorithm, and its performance is evaluated based on its physical properties and adherence to electrical safety and biocompatibility standards.

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

For this submission, the "ground truth" implicitly refers to:

• Recognized Standards: The published requirements of standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-4, ISO 10993-10, ISO 10993-12, and 21 C.F.R. § 898.
• Predicate Device Specifications: The established design and performance parameters of the legally marketed predicate device, NuFace® Plus (K103472), which serves as the benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. The device is not an AI/ML algorithm that requires a training set.

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

Not applicable. No training set is involved.

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