(311 days)
2 Face / Face Evolution is a hand-held device for over-the counter aesthetic purposes.
(1) The EMS mode is indicated for facial stimulation;
(2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
2 Face / Face Evolution (Model: 2 Face / Face Evolution) is consists of a Main Unit, conductive gel, charger and user manual, it's a multifunctional comprehensive beauty instrument. It's combined with the most effective two kinds of techniques of internationally recognized skin care:
The EMS Mode is intended for facial stimulation for aesthetic purposes. It produces microcurrent discharged through the EMS Mode treatment probe. Microcurrent is an aesthetic modality providing electric current in millionths of an ampere. The EMS mode is indicated for aesthetic facial stimulation and requires the use of conductive gel. Photon mode: The red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the treatment of the mild to moderate inflammatory acne. It emits energy in the red spectrum for the treatment of periorbital wrinkles. The PHOTON Mode treatment probe is designed for contact with the face. The device continually pulses the light output, and provides 4 kinds of output intensity level.
This document is a 510(k) summary for the medical device "2 Face / Face Evolution" by Heat In A Click. It asserts substantial equivalence to predicate devices based on safety and performance evaluations.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria or performance metrics in a typical sense for an AI-powered device. Instead, it demonstrates compliance with various medical device standards and provides a comparison table against two predicate devices. The "performance" in this context refers to the device's adherence to safety and electromagnetic compatibility standards, as well as its physical and electrical specifications matching or being within acceptable ranges compared to the predicates.
The closest we can get to a table for an AI device would be:
| Feature/Metric (if AI were present) | Acceptance Criteria (Implied: Compliance with relevant standards and ranges of predicate devices) | Reported Device Performance (as compared to predicates) |
|---|---|---|
| Biocompatibility | AAMI/ANSI/ISO 10993-5:2009(R) 2014 (in vitro cytotoxicity), ISO 10993-10:2010-08-01 (irritation and skin sensitization) | Compliant |
| Electromagnetic Compatibility (EMC) | IEC/EN 60601-1-2: 2014-02 | Compliant |
| Basic Safety & Essential Performance (Home Healthcare) | IEC 60601-1-11:2010 | Compliant |
| Basic Safety & Essential Performance (Non-laser Light Source) | IEC 60601-2-57:2011 | Compliant (Wavelengths, Energy emitted, Irradiation area, Irradiances within deviation range, LED power, etc., are compared and found to be compliant with requirements, see table sections on Waveform and Shape, Wavelengths, Energy emitted, etc.) |
| Usability | IEC 60601-1-6: 2010 (Third Edition), IEC 62366:2007 + A1:2014 | Compliant |
| Basic Safety & Essential Performance (Nerve & Muscle Stimulators) | IEC 60601-2-10: 2012 (Second Edition) | Compliant (e.g., Output Voltage, Current, Phase Charge, Current Density, Power Density, Pulse Duration, Frequency are compared and found to be compliant with requirements) |
| Battery Safety | IEC 62133 Edition 2.0 2012-12 | Compliant |
| Software Life-Cycle Processes | IEC 62304: 2006 (First Edition) | Compliant |
| Compliance with 21 CFR 898 | Yes | Yes |
2. Sample Size Used for the Test Set and the Data Provenance
This document primarily describes a device for aesthetic purposes (facial stimulation, periorbital wrinkles, mild to moderate inflammatory acne) and focuses on engineering and safety testing. It does not mention a "test set" in the context of an AI algorithm or data-driven performance evaluation. The testing conducted is laboratory bench testing against established medical device standards. Therefore, there is no sample size or data provenance related to a test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the document does not describe a study involving a "test set" requiring ground truth established by experts for an AI algorithm. The evaluations are against technical standards and comparisons to predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable as there is no "test set" requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. The device described is a physical hand-held aesthetic device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI-related effect size data is presented.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is an electro-mechanical and light-emitting device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established performance and safety requirements outlined in the various international medical device standards (e.g., ISO, IEC) and the comparative specifications of the legally marketed predicate devices. The device's performance is measured against these technical standards and predicate device characteristics, not against clinical outcomes or expert consensus on patient data.
8. The Sample Size for the Training Set
This information is not applicable as the document does not describe an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no AI algorithm training set.
§ 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).