(348 days)
The NūFACE® Plus Facial Toning Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (21 CFR 801 Subpart C).
Stimulate the face; skin toning
Over-the-Counter Cosmetic Use
NūFace® Plus is a Facial Toning Device intended for facial stimulation. It produces microcurrent discharged through the two spherical probes. Microcurrent is an aesthetic modality providing electric current in millionths of an ampere and has the ability to increase facial contour and firm the skin and muscles by supplying 80 - 400 µA.
The device measures 3" W x 5.25" L x 1.25" D. Its outer case is injection molded of thermoplastic resin and the output contacts (probes) consist of chrome-plated spheres. The device is powered by 4 rechargeable batteries. The NūFACE® Plus comes with a rechargeable base, which measures 3.25" W x 4" L x 3.25" D.
To turn the device on, an ON/OFF button is pressed. 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® Plus is a facial toning device. Its outer case is injection molded thermoplastic resin. The output contacts (probes) consist of chrome-plated spheres. The device, powered by four rechargeable AA nickel-metal hydride batteries, produces a micro-current that is discharged through the two fixed, smooth spherical probes. To turn the device on, the on/off button is pressed. An ascending tone sounds, indicating the device on. One to five red LED lights 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® Plus probes are designed for optimal contact with the face. The NuFACE® Plus micro-current continually alternates between the positive and negative probes, and allows the user to adjust settings for a personalized comfort level. The NuFACE® Plus device requires the use of a conductive solution or gel. To promote proper use and feedback to the user, the NuFACE® Plus beeps to cue the user to relocate the device approximately every 5 seconds. The beep also informs the user that the two spheres are making contact with the skin surface. An alert tone sounds to indicate that both probes are not touching the skin during treatment.
The provided document is a 510(k) summary for the NuFACE® Plus device, seeking substantial equivalence to a predicate device. It primarily focuses on comparing the technological characteristics and indications for use between the new device and its predicate. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to its cosmetic effectiveness or performance in a clinical setting.
The compliance data mentioned relates to meeting general FDA performance standards for transcutaneous electrical nerve stimulators (21 CFR §898) and electrical safety/emissions standards (IEC 60601-1 and IEC 60601-1-2). These are technical safety and performance standards, not acceptance criteria for cosmetic outcomes.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.
Here's why and what information is available (or explicitly missing):
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A table of acceptance criteria and the reported device performance: This information is NOT present. The document compares technical specifications and features of the NuFACE® Plus with its predicate, the original NuFACE® device, but not against any pre-defined acceptance criteria for cosmetic outcomes.
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Sample size used for the test set and the data provenance: This information is NOT present. No clinical or performance study involving a "test set" of subjects is described. The "compliance data" refers to engineering and electrical safety testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is NOT present, as there's no described test set or ground truth determination related to clinical performance.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is NOT present.
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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: This is NOT applicable. The device is a Transcutaneous Electrical Nerve Stimulator for cosmetic use, not an AI-assisted diagnostic or imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is NOT applicable. The device is a physical, user-operated electrical stimulation device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is NOT present, as no clinical performance study or ground truth determination for cosmetic efficacy is described.
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The sample size for the training set: This information is NOT present. There is no mention of a "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established: This information is NOT present.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence based on technological characteristics and intended use to a previously cleared device, along with compliance to general safety standards. It does not include data from clinical performance studies against specific acceptance criteria for cosmetic efficacy.
§ 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).