(119 days)
The NuFACE FIX+ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
FIX+ is a portable hand-held microcurrent stimulator for facial skin stimulation indicated for over-the-counter cosmetic use. Main components: Main unit, USB power cable, and NuFACE Line Smoothing FIX Serum conductivity gel. Housing of the device made from Acrylonitrile Butadiene Styrene, with chrome-plated spherical probes. Inclusion of three microcurrent output frequency levels. Integrated rechargeable lithium-ion battery.
The provided text is a 510(k) summary for the NuFACE® FIX+ device, which is a microcurrent stimulator for facial stimulation. It describes the device, its intended use, and how it compares to a predicate device. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study report proving a device meets specific acceptance criteria for a diagnostic or AI-driven medical device.
Therefore, the information required to answer the prompt (acceptance criteria, study details for an AI/diagnostic device, sample sizes, expert involvement, etc.) is not present in the provided text. The document focuses on electrical safety, EMC, bench testing of output characteristics, and biocompatibility to demonstrate safety and performance equivalence to a similar device already on the market.
Specifically:
- Acceptance Criteria Table and Reported Performance: The document provides "Performance Specifications Comparison" in Table 4, but these are comparisons to the predicate device's specifications, not acceptance criteria for a diagnostic claim, nor are they reported "device performance" in the sense of clinical accuracy or efficacy for a diagnostic output.
- Sample Size for Test Set and Data Provenance: Not applicable. The "testing summaries" refer to bench testing of the device's electrical characteristics and safety, not testing on human subjects for a diagnostic outcome.
- Number of Experts and Qualifications: Not applicable. The testing described is engineering and safety testing.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: Not applicable. The device is a cosmetic facial stimulator, not an AI-assisted diagnostic tool for human readers.
- Standalone Performance: The bench testing addresses the device's standalone electrical performance, but not in the context of a diagnostic algorithm.
- Type of Ground Truth: Not applicable for a diagnostic purpose. Ground truth for the engineering tests would be established by validated measurement equipment.
- Sample Size for Training Set: Not applicable. This device does not appear to employ machine learning that would require a training set in the conventional sense of an AI model for diagnostic imaging.
- Ground Truth for Training Set: Not applicable for the same reason.
In summary, the provided document details the regulatory pathway for a Class II medical device based on substantial equivalence, primarily focusing on engineering and safety characteristics. It is not a report on a study proving the device meets acceptance criteria for a diagnostic or AI-assisted application in the way the prompt implies.
§ 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).