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The NuFACE FIX™ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.

NuFACE FIX Skin Toning Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use. Two (2) spherical electrodes, fixed on the NuFACE FIX device main face, deliver low level electrical impulses (aka. microcurrent) to targeted locations on the face.

The NuFACE FIX Skin Toning Device is intended for facial stimulation for over-the-counter cosmetic use. The 510(k) summary provided indicates substantial equivalence to the predicate device, NuFACE Trinity ELE (K131251), rather than presenting specific performance criteria and a study demonstrating the device meets those criteria.

However, since a direct study proving the device meets individual acceptance criteria is not provided, the following outlines the acceptance criteria established by the manufacturer and the reported performance as demonstrated through a substantial equivalence comparison to a predicate device, rather than a standalone performance study with specific device performance metrics against predefined acceptance thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

As this submission establishes substantial equivalence, the "acceptance criteria" for the new device are implicitly that its technological characteristics, intended use, indications for use, and performance data are either the same as or demonstrate equivalence to the predicate device.

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

The primary evidence presented is a comparison against a predicate device's specifications and compliance with recognized standards. There isn't a "test set" in the traditional sense of a clinical trial or performance study with a specific sample size of patients or images for which direct performance metrics against acceptance criteria are measured.

Instead, the "test set" for this substantial equivalence submission comprises:

• Engineering and Bench Testing Data: This includes measurements of electrical output specifications (voltage, current, pulse width, frequency), mechanical integrity, and software functionality.
• Safety Standard Compliance Reports: Documentation demonstrating that the device meets the requirements of various international and national safety and performance standards (e.g., IEC 60601 series, ISO 14971, IEC 62366).
• Usability Study: A prospective usability study was conducted. Details on sample size or provenance are not provided in this summary.

Data Provenance: The data originates from the manufacturer's internal testing and evaluations, conducted according to recognized industry standards. No external clinical data or specific geographic provenance (e.g., country of origin) for a clinical "test set" is explicitly mentioned for the substantial equivalence claim. The usability study is described as "prospective" but no further detail on its sample size or provenance is provided within this document.

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

Given that this is a 510(k) submission based on substantial equivalence to a predicate device and compliance with engineering and safety standards, the concept of "ground truth" derived from expert consensus on a clinical test set is not directly applicable in the same way as it would be for a diagnostic AI device.

• Engineering/Safety Standards: The "ground truth" here is established by the specifications and performance requirements outlined in the international and national standards themselves (e.g., IEC 60601 series). Compliance is typically assessed by engineers and technicians who are qualified in the relevant testing methodologies and regulatory requirements.
• Usability Study: If the usability study involved expert feedback, the qualifications of those experts (e.g., human factors engineers, ergonomists, clinicians who would use such a device) would be relevant. However, this detail is not provided in the summary.

4. Adjudication method for the test set

Not applicable in the context of this 510(k) submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or reader studies where multiple experts independently review cases and then resolve disagreements to establish a consensus ground truth. This type of clinical adjudication is not described or implied for the non-clinical and technical testing presented for substantial equivalence.

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. The NuFACE FIX Device is a direct-to-consumer cosmetic device, not an AI-assisted diagnostic or therapeutic tool that would involve "human readers" or "AI assistance" in the clinical decision-making process. Therefore, an MRMC comparative effectiveness study involving AI assistance was not performed.

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

This refers to an "algorithm-only" performance, which is not applicable here as the device is a physical, microcurrent stimulation device for cosmetic use, not a software algorithm. The device does have software (as confirmed by IEC 62304 compliance), but it's embedded control software, not a standalone AI algorithm with a distinct performance metric for a specific clinical task.

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

The "ground truth" for demonstrating substantial equivalence and safety/performance in this context is predominantly:

• Engineering Specifications and Measurements: The measured electrical output values (voltage, current, pulse width, frequency) are compared directly against the specified values and the predicate device's values.
• Compliance with Recognized Standards: The successful completion of tests required by established international and national safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60529). These standards themselves define what constitutes acceptable performance and safety.
• Predicate Device Comparison: The "ground truth" for the equivalence claim is the established safety and effectiveness profile of the legally marketed predicate device (NuFACE Trinity ELE, K131251). The new device is deemed safe and effective if its differences from the predicate device do not raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. As this device is not an AI/ML algorithm requiring a training set, this concept does not apply.

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

Not applicable, as no training set for an AI/ML algorithm was used.

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