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The device is intended for facial stimulation by electrode heads for cosmetic use. The device is also intended for the treatment of periorbital wrinkles with red Light Emitting Diode (LED) head. It is for over-the-counter use.

The Device is equipped with three replaceable treatment heads; two treatment heads are electrode heads for micro current output to stimulate facial skin (Bigger one, and smaller one), the other treatment head is LED lamp holder.

The device is intended for facial stimulation by electrode heads for cosmetic use. The device is also intended for the treatment of periorbital wrinkles with red Light Emitting Diode (LED) head. It is for over-the-counter use.

For two micro current treatment heads of instrument, they can be exchanged for different skin part to use. The bigger one is for face tissue on cheeks and the smaller one is for facial tissue below eye region. It should be used about 10 minutes/2 to 3 times per week. The red is for red-light caring (about 3 minutes/2 to 3 times per week.)The product is supplied with an internal lithium rechargeable battery; It can be charged by 5V voltage of battery charger connected by standard USB cable. During battery charging, the LED lights start flash circling until charging is completed.

There are two kinds of electrode heads, one bigger electrode head is for cheek stimulation; and smaller electrode head is for stimulation on under eyes area. There are no electronic component inside of either heads. It is only for conduct stimulation current.

This document is a 510(k) Pre-Market Notification for the "Micro-current Wrinkle Reduction Facial Service, Model EP-400". It details the device's technical specifications and compares it to predicate devices to establish substantial equivalence. However, it does not contain a study proving the device meets specific acceptance criteria in terms of clinical performance or effectiveness beyond safety and technical standards.

The document discusses tests for safety and technical performance, but not clinical efficacy in reducing wrinkles or providing facial stimulation results. The "Test Summary" section lists various engineering and safety standards used for evaluation, which are common for device clearance but do not address clinical outcomes.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria for clinical performance (e.g., wrinkle reduction percentage, subjective improvement scores) or reported device performance against such metrics. Instead, the acceptance is based on compliance with various engineering, safety, and compatibility standards.

2. Sample size used for the test set and the data provenance

The document describes bench testing for engineering and safety standards, not a clinical test set with human subjects. Therefore, the concept of "sample size used for the test set" and "data provenance" (country of origin, retrospective/prospective) in a clinical context is not applicable here. The testing was performed on the device itself in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as there is no clinical test set with a "ground truth" established by human experts for clinical outcomes. The "ground truth" for the engineering and safety tests would be the specifications outlined in the respective standards, verified by testing specialists in a lab.

4. Adjudication method for the test set

Not applicable as there is no clinical test set requiring adjudication of findings.

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

Not applicable. This device is a physical therapy/cosmetic device, not an AI-powered diagnostic or assistive technology for human readers/clinicians, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is geared towards AI/software performance. The document describes a physical medical device. While it mentions "Software verification and validation test" according to FDA guidance, this refers to the internal software controlling the device's functions, not an AI algorithm performing a standalone clinical task. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable in the context of clinical efficacy for this device.

7. The type of ground truth used

For the safety and performance tests conducted, the "ground truth" would be the technical specifications, requirements, and acceptable ranges defined by the cited IEC and ISO standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62471, ISO 10993-5, ISO 10993-10, and FDA Guidance for Pre Market Submissions and for Software Contained in Medical Devices, Guidance for Powered Muscle Stimulator).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI algorithm.

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