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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.

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The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

The NuFACE Trinity Device(proposed) is intended for facial and neck skin stimulation and is indicated for over-the-counter cosmetic use. It is identical to that of its NuFACE Plus (predicate) and its technological characteristics remain unchanged. It produces microcurrent discharged through the two spherical probes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the NuFACE Trinity Device:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary for the NuFACE Trinity Device does not present typical "acceptance criteria" in the sense of performance metrics with specific thresholds (e.g., sensitivity > X%, specificity > Y%). Instead, it establishes substantial equivalence to a predicate device (NuFACE Plus). The primary "acceptance criteria" appear to be that the proposed device (NuFACE Trinity) is identical in technological characteristics and performance standards to the predicate device, with an expanded intended use to include the neck.

The table presented is a "Substantial Equivalence Comparison Table" which compares the proposed NuFACE Trinity Device to its predicate, the NuFACE Plus. The performance is "reported" by asserting that the devices are critically similar or identical in most technical specifications.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Literature provided and usability studies conducted demonstrate that the device is substantially equivalent to the predicate given the new indications." This implies that some form of usability study was performed for the new indications (neck stimulation). However, the document does not specify the sample size for any test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature). The primary reliance is on the device being identical to the predicate from a technical standpoint.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention any experts being used to establish ground truth for a test set in the traditional sense of clinical performance evaluation. The "ground truth" for substantial equivalence rests on the comparison of specifications and the assumption that the predicate device (NuFACE Plus) already established its safety and effectiveness.

4. Adjudication Method

There is no mention of an adjudication method for a test set. This type of method is typically used in studies where human readers evaluate cases and their discrepancies are resolved. Since this submission relies on substantial equivalence through technical and functional identicality, such a method does not apply here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done as described. The submission focuses on substantial equivalence of a new device (NuFACE Trinity) to an existing one (NuFACE Plus), not on improving human reader performance with AI assistance. The device itself is an electrical stimulator, not an AI-powered diagnostic tool.

6. Standalone Performance Study

A standalone performance study (algorithm only performance without human-in-the-loop) was not explicitly done or reported in the traditional sense. The "performance" assessment focuses on the identical nature of the NuFACE Trinity to the NuFACE Plus in terms of electrical output, safety, and EMC. The non-clinical testing for electrical safety, EMC, and biocompatibility, as well as the usability studies, implicitly serve as a standalone performance assessment to demonstrate that the expanded use (neck) is safe and effective when delivered by an identical device.

7. Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the predicate device (NuFACE Plus), as accepted by the FDA when it was cleared (K103472). The submission's argument for the NuFACE Trinity is that its identical technological characteristics and performance standards mean it also meets those same safety and effectiveness criteria, even with the expanded anatomical site (neck), which was further supported by usability studies.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This is because the device is not an AI/machine learning device that requires a training set for model development. The approval pathway is an equivalence pathway, not one that requires de novo clinical validation with training and test sets for an algorithm.

9. How Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML algorithm for this device, there is no ground truth established for a training set. The entire premise is based on the previously cleared predicate device.

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