(105 days)
The NuFace® Facial Toning Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (21 CFR 807 Subpart C).
NuFace® is a Facial Toning Device intended for facial stimulation. The device measures 7" L x 2.5" W x 1" D. Its outer case is injection molded of thermoplastic resin, ABS UL 94 HB, and the output contacts (probes) consist of chrome-plated spheres. The device, powered by a 9-volt battery, produces microcurrent that is discharged through the two fixed, smooth spherical probes. To turn the device on, the thumbwheel is pushed upwards. A Green LED light will then illuminate, indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face. The NuFace® probes are designed for optimal contact with the face. The NuFace® device continually alternates between the positive and negative probes, and allows the user to adjust settings from 0 to 400 microamps for a personalized comfort level. The NuFace® device requires the use of a conductive derma gel.
Based on the provided text, the NuFace® device is a facial toning device that delivers low-level electrical impulses for facial stimulation, indicated for over-the-counter cosmetic use. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with FDA's performance standards | The NuFace® Facial Toning Device was tested and found to be in compliance with FDA's performance standards set forth in 21 C.F.R. §898. |
| Compliance with EU Declaration of Conformity under the EMC and Safety Standards IEC 60601-1 and IEC 60601-1-2 | The NuFace device was also tested and found to be in compliance with the EU Declaration of Conformity under the EMC and Safety Standards IEC 60601-1 and IEC 60601-1-2. Accordingly, NuFace® has received a CE Mark under the Medical Device Directive 93/42/EEC. |
| Demonstrated substantial equivalence to predicate devices for safety and effectiveness | Non-clinical performance data from comparative analyses demonstrated the NuFace® device is as safe and effective as, and performs similarly to, the predicate 510(k) approved transcutaneous electrical nerve stimulator devices for OTC cosmetic use. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a specific "test set" in the context of a clinical performance study with human subjects. The performance data presented is primarily "non-clinical performance data from comparative analyses." Therefore, information on sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable here as a clinical study with human results is not described.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This is not applicable as the document does not describe a study involving expert assessment of a ground truth for a test set. The evaluation is based on device compliance with standards and comparative analysis to predicate devices.
4. Adjudication Method for the Test Set
This is not applicable since a clinical test set requiring adjudication by experts is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document describes a comparative analysis to predicate devices to establish substantial equivalence, not a study evaluating human reader improvement with or without AI assistance. The NuFace® is a direct-to-consumer electrical stimulation device, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
This is not applicable as the NuFace® is a physical device for facial stimulation, not a software algorithm. The "performance data" refers to compliance with safety and electrical standards and non-clinical comparisons to predicate devices.
7. Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness of the predicate devices and compliance with regulatory performance standards (21 C.F.R. §898, IEC 60601-1, IEC 60601-1-2). The NuFace® device's performance is gauged against these established benchmarks and standards.
8. Sample Size for the Training Set
This is not applicable as the NuFace® is a physical device and not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI/ML algorithm.
Summary of the Study Demonstrated:
The "study" or rather, the evidence provided for the NuFace® device, is centered on demonstrating substantial equivalence to existing, legally marketed predicate devices (FaceMaster Facial Toning System and Rejuvenique) for the purpose of a 510(k) clearance. This is a regulatory pathway in the US that allows a new device to be marketed without requiring rigorous clinical trials if it can be shown to be as safe and effective as devices already on the market.
The evidence presented includes:
- Compliance with FDA Performance Standards: The device was tested and found to meet FDA's performance standards in 21 C.F.R. §898.
- Compliance with European Standards: The device met EU EMC and Safety Standards (IEC 60601-1 and IEC 60601-1-2) and received a CE Mark.
- Non-Clinical Comparative Analysis: Data from comparative analyses between the NuFace® device and the two predicate devices showed that the NuFace® is "as safe and effective as, and performs similarly to" the predicates. This comparison likely involved evaluating features, technological characteristics, and output parameters to ensure they fall within acceptable ranges similar to the cleared predicate devices.
In essence, the "study" is a regulatory submission demonstrating equivalence through technical characteristics and compliance with recognized safety standards, rather than a clinical trial demonstrating efficacy or performance against specific clinical acceptance criteria.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).