(89 days)
The Facial Toning device is intended to stimulate the face. The device is intended for cosmetic use.
The Facial Toning devices, which come in two models (UIC-189, UIC-589), are intended for facial stimulation and are indicated for prescription cosmetic use. The anatomical site for application of the devices are the face.
UIC-189 is battery powered, has 4 output channels and has 4 operation programs.
UIC-589 is AC powered, has 10 output channels and has 4 operation programs.
The device is equipped with accessories of self-adhesive pads (cleared under K160081), electrode probes, electrode cables and adapters. All accessories, including self-adhesive pads, electrode probes, electrode cables and adapters can only be changed or replaced by a qualified person.
This FDA 510(k) summary does not contain information about the performance of an AI/ML device. Instead, it describes a "Facial Toning device" which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, specifically for cosmetic use involving facial stimulation.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective) for an AI/ML device.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI versus without AI assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
- The sample size for the training set of an AI/ML device.
- How the ground truth for the training set was established for an AI/ML device.
The document primarily focuses on demonstrating substantial equivalence to predicate devices (K181062 and K130065) through a comparison of technical specifications and compliance with electrical safety and biocompatibility standards for the TENS device.
Information available regarding the Facial Toning Device:
Acceptance Criteria and Reported Device Performance (Summary from Non-clinical Testing section):
The device "met all requirements" based on bench tests. The compliance standards serve as the acceptance criteria for various aspects of the device's safety and performance:
| Acceptance Criteria (Standards Complied With) | Reported Device Performance (Implied by Compliance) |
|---|---|
| Electrical Safety & Essential Performance: | Device meets general requirements for basic safety and essential performance of medical electrical equipment. |
| AAM/ANSI ES 60601-1:2005 & A1:2012, C1:2009(R)2012 & A2:200(R)2012 (Cons. Text) [Incl. AMD2:2021] (IEC 60601-1:2005, MOD) | |
| Electromagnetic Compatibility: | Device meets requirements for electromagnetic disturbances. |
| IEC 60601-1-2 Edition 4.1 2021-09 CONSOLIDATED VERSION | |
| Nerve & Muscle Stimulator Specific Safety: | Device meets particular requirements for basic safety and essential performance of nerve and muscle stimulators. |
| IEC 60601-2-10 Edition 2.1 2016-04 | |
| Biocompatibility - Cytotoxicity: | Device components meet requirements for in vitro cytocompatibility. |
| ISO 10993-5 Third Edition 2009-06-01 | |
| Biocompatibility - Skin Sensitization: | Device components meet requirements for skin sensitization. |
| ISO 10993-10 Fourth edition 2021-11 | |
| Biocompatibility - Irritation: | Device components meet requirements for irritation. |
| ISO 10993-23 First edition 2021-01 | |
| Battery Safety (for UIC-189 model): | If applicable (for battery-powered models), device's lithium systems (batteries) meet safety requirements for portable secondary cells and batteries made from them. |
| IEC 62133-2 Edition1.0 2017-02 |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a "Non-clinical Testing Summary" which involved bench tests.
The document indicates these bench tests verified that the proposed device met all requirements as outlined by the listed international standards. No details on sample size for these bench tests, data provenance (beyond the fact they were "bench tests"), or expert involvement are provided. There is no mention of an AI component or associated studies like MRMC or standalone performance evaluations for an algorithm.
§ 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).