(206 days)
The NuFACE® Trinity Plus Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
The NuFACE® Trinity Plus comprises the Trinity Plus device main body, a Trinity Plus microcurrent attachment head, a charging cradle and a wall-mount power adaptor. A tube of NuFACE® Gel Primer is provided with the device as an accessory. The device and all associated components are reusable and provided non-sterile. The NuFACE® Trinity Plus is a hand-held device that produces low levels of microcurrent which is discharged through two dual-plated chrome spheres for aesthetic purposes. The device provides audible feedback to inform the user to relocate the device to treat a new location on the skin. The device also includes "hum" features to guide the user during the treatment cycle. The device is powered by one internal rechargeable, non-removable battery which is charged via a provided wireless charging cradle. The charging cradle connects to a provided wall-mount power adaptor. Microcurrent output is cut-off while the device is sitting on the charging cradle either charging the battery or when the battery is fully charged. The enclosures of the device main body, the attachment head and the charging cradle are made from injection molded ABS thermoplastic material. The dual spheres on the attachment head use chromium. The device includes an 'ON/OFF' multifunction button to turn the device on and off, start and stop treatment, increase or decrease the microcurrent output level and pair with a smart device. The device also includes a "BOOST" button that temporarily increases the microcurrent output level. The device includes indicator LED's to provide information to the user on the status of the device and the progress of the treatment. The device is the capable of pairing with compatible smart devices using Bluetooth Low Energy (BLE) wireless communications technology. This technology allows the device to communicate with other devices running the NuFACE® App which allows the user to select and run pre-programmed treatment profiles. The NuFACE® Trinity Plus provides microcurrent output at selected frequencies from 0.3 to 50 Hz.
This document is a 510(k) summary for the NuFACE® Trinity Plus Device. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The document focuses on demonstrating that the new device is as safe and effective as the predicate, not on proving new clinical efficacy or superiority through rigorous clinical trials.
Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/Machine Learning (ML) device, which typically involves performance metrics like sensitivity, specificity, accuracy, and detailed clinical study designs with human readers and ground truth, is not applicable to this document.
This FDA submission is for a physical medical device (Transcutaneous Electrical Nerve Stimulator for Pain Relief, used for cosmetic facial and neck stimulation) and primarily relies on a comparison of technological characteristics, safety data (biocompatibility, electrical safety, EMC), and software verification and validation to demonstrate substantial equivalence to a predicate device.
Here's why the AI/ML-centric questions are not applicable:
- No AI/ML Component: The document describes a device that "produces low levels of microcurrent" and has "indicator LED's," a "multifunction button," and Bluetooth Low Energy for app connectivity to select pre-programmed treatment profiles. There is no mention of an AI or ML algorithm making diagnostic or therapeutic decisions, interpreting data, or providing automated recommendations.
- Safety and Substantial Equivalence, Not Efficacy Proof: The core purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a predicate device. This typically involves showing that its indications for use, technological characteristics, and safety and effectiveness profiles are similar enough that it doesn't raise new questions of safety or effectiveness. It's not a P-value seeking clinical trial to prove a new mechanism or superior efficacy.
- "Clinical Testing" was not performed: The document explicitly states under section 9, "Clinical Testing: The substantial equivalence for the subject device will not be demonstrated by results of clinical testing. Therefore, no clinical testing was performed." This clearly indicates that no human-subject efficacy study was conducted for this submission.
In summary, this document does not describe the kind of study (e.g., MRMC, standalone performance) that would be conducted for an AI/ML device requiring rigorous clinical performance validation against acceptance criteria based on metrics like sensitivity or specificity. The "acceptance criteria" here implicitly relate to demonstrating safety and similar performance to the predicate device through non-clinical testing.
§ 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).