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NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use. Four (4) spherical electrodes, fixed on the NuBODY device main body, deliver low level electrical impulses (microcurrent) to targeted locations on the body.

This document describes a 510(k) premarket notification for the NuBODY Skin Toning Device, claiming substantial equivalence to the NuFACE Plus device. As such, the study focuses on characterizing the new device's technical specifications and safety standards rather than a clinical efficacy trial.

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

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

The document does not explicitly state "acceptance criteria" in a separate section. Instead, the performance is demonstrated by comparing the new device (NuBODY) to a legally marketed predicate device (NuFACE Plus) based on their technological characteristics, basic unit characteristics, and output specifications. The assertion is that NuBODY meets the predicate's performance by being "the same, or similar," and that "differences do not alter the clinical utility."

Therefore, the "acceptance criteria" are implied to be that the NuBODY device should have comparable performance characteristics and meet the same safety standards as the NuFACE Plus predicate device.

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 describes bench testing for nonclinical performance and safety. It tests "a production equivalent of the NuBODY, and a commercial unit of the predicate."

• Sample Size for Test Set: One "production equivalent" NuBODY device and one "commercial unit" of the NuFACE Plus predicate device were used for the performance testing.
• Data Provenance: Not explicitly stated, but the testing would have been conducted by or for the manufacturer (Carol Cole Company/NuFACE) in the USA (Vista, CA is the address). This is non-clinical, prospective bench testing.

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)

This product is a microcurrent stimulator for cosmetic use, and the submission is a 510(k) based on substantial equivalence demonstrated through bench testing and compliance with recognized standards. There is no mention of clinical studies using human subjects or expert clinical panels to establish "ground truth" for the performance criteria in this document. The "ground truth" for this type of submission is typically derived from established engineering and safety standards and comparison to a predicate device's specifications.

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

Not applicable. As described above, there was no clinical study involving human readers or assessment that would require an adjudication method. The evaluation was based on non-clinical bench testing against engineering specifications and predicate device characteristics.

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 purposes, not an AI-powered diagnostic device or a system designed to assist human readers. Therefore, an MRMC comparative effectiveness study or AI-related performance metrics are not relevant to this submission.

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

Not applicable. This is a physical electronic device, not an algorithm.

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

The "ground truth" for this 510(k) submission is primarily the technical specifications and safety standards as defined by regulatory bodies (e.g., FDA regulations, IEC standards) and demonstrated by the performance of the predicate device (NuFACE Plus). The "study" (bench testing) aims to confirm that the new device's technical output and safety parameters are comparable and compliant.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

Not applicable, as there is no training set.

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