(196 days)
CEC101 and EE0101:
Microcurrent Facial Device is intended for facial stimulation for over-the-counter aesthetic use.
EEI101:
Microcurrent Facial Device is intended for facial, neck and body skin stimulation for over-the-counter aesthetic use.
The Microcurrent Facial Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, membrane cloth, conductive gel and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.
The provided FDA 510(k) clearance letter and summary for the Microcurrent Facial Device (K244004) does not contain information on acceptance criteria for a clinical study or a study proving the device meets performance criteria beyond safety and electrical standards.
This document primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons, safety testing (biocompatibility, electrical safety, EMC), and software verification/validation. It explicitly states that "The following performance data were provided in support of the substantial equivalence determination," and lists the aforementioned safety and software tests.
The listed "Indications for Use" for this device are for "facial stimulation for over-the-counter aesthetic use" and "facial, neck and body skin stimulation for over-the-counter aesthetic use." These are aesthetic claims, not medical claims requiring clinical efficacy studies in the same way a device for diagnosing or treating a disease would.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance for clinical efficacy
- Sample size used for the test set and data provenance related to clinical efficacy
- Number of experts used to establish ground truth or their qualifications for clinical efficacy
- Adjudication method for a clinical test set
- MRMC comparative effectiveness study or effect size
- Standalone algorithm performance
- Type of ground truth used for clinical efficacy
- Sample size for the training set (for clinical efficacy)
- How ground truth for the training set was established (for clinical efficacy)
The document focuses solely on engineering and safety performance to demonstrate substantial equivalence, not clinical efficacy for aesthetic outcomes. The "performance data" section (Page 15) explicitly lists only biocompatibility, electrical safety, EMC, and software verification/validation as the bases for establishing substantial equivalence.
In summary, for K244004, the acceptance criteria and proof of meeting them are primarily related to safety and functional performance, not clinical efficacy for aesthetic outcomes, as it falls under the "Transcutaneous Electrical Nerve Stimulator For Pain Relief" product code (NFO) but is indicated for aesthetic use. The FDA clearance is based on the device being "as safe, as effective and performs as well as the legally marketed predicate devices" for its intended aesthetic stimulatory purpose, which is proven through the technical and safety evaluations outlined.
If this were an AI/ML medical device, the information requested would be crucial. However, for a microcurrent facial device, the regulatory pathway relies on different types of "performance data."
§ 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).