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For micro current stimulation mode: The Smart Photon Micro-current Device is intended for facial stimulation and is indicated for over-the-counter aesthetic use.

For red light irradiation mode: The red light is intended for the treatment of periorbital wrinkles,

For blue light irradiation mode: The blue light is for the treatment of mild to moderate acne.

There are Micro current electrodes, Red LEDs, Blue LEDs in the treatment head for their individual treatment function. The device is provided with three operating function modes: Micro current stimulation mode, Red light irradiation mode, Blue light irradiation mode. Three operation modes can be selected by the "Mode" button. These modes only can work separately.

For Micro current stimulation mode:

The device has two pairs of electrode contactors for facial stimulation by applying an electrical micro current to electrodes. The output waveform is formed of regulated Voltage of Biphasic pulse and provided with 5 levels of output intensity, which can be adjusted by user.

The device requires the use of conductive gel provided together with the device.

For LED phototherapy function:

The device also can provide specific photon spectrum by LED lamps for Red light irradiation mode and Blue light irradiation mode. There are Red LED lamps and Blue LED lamps assembled in the treatment head.

In Red light irradiation mode, the device utilizes Light Emitting Diodes to emit red light. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of red light is 630±10nm and its power density is 80 mW/cm2.

In Blue light irradiation mode, the device utilizes Light Emitting Diodes to emit blue light. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of blue light is 415 ±10 nm and its power density is about 50 mW/cm².

For the facial stimulation model, the recommend treatment session is 10 minutes/2 to 3 times per week.

For light irradiation of red light, the recommend treatment session is 3 minutes/ 2-3 times per week. And for blue light, the recommend treatment session is 4 minutes/ 2 times per week on each treatment area.

The provided text is a 510(k) summary for the "Smart Photon Micro-current Device: EP-300". This document primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and safety testing. It does not include acceptance criteria for clinical performance or details of a clinical study to prove the device meets such criteria.

The "Test Summary" section (page 6) lists the tests performed, which are primarily related to safety, electrical compatibility, and software validation, not clinical effectiveness. There is no information about clinical acceptance criteria for aesthetic outcomes (e.g., reduction in periorbital wrinkles, improvement in acne).

Here's an analysis of what information is provided regarding testing and comparison, structured to answer your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria for clinical performance or a table of reported device performance against such criteria. Instead, it compares the subject device's specifications to those of predicate devices and states that safety and performance were evaluated through various engineering and electrical tests. The implicit "acceptance criterion" is to demonstrate substantial equivalence to the predicate devices through technical similarities and compliance with international safety standards.

The table below summarizes the comparative technical specifications and the conclusion of "Substantial Equivalence (SE)" provided in the document. This is not a direct assessment of an "acceptance criterion" for clinical efficacy, but rather a comparison of technical features to establish equivalence for regulatory purposes.

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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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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.

The LED Phototherapy Device (Model: PL-120) directly applies photon light onto skin surface by making using of specific photon spectrum. Each device is equipped with two LED lamp holder, one is emitting blue light which wavelength at 415nm±3nm. The other lamp emits red light which wavelength at 630nm±3nm. The red light is intended for the treatment of periorbital wrinkles. The blue light is intended for the treatment of the mild to moderate inflammatory acne. The user can change the treatment lamp according to their own needs. It employed a 3.7 V Li-ion battery to provide power, and the internal battery is rechargeable. And the device has five options for setting the auto-off time, as below table listed:

The provided document is a 510(k) summary for a medical device (LED Phototherapy Device) seeking substantial equivalence to predicate devices. It describes the device, its intended use, and test summaries for safety and performance. However, this document does not contain information about a clinical study involving human patients, multi-reader multi-case (MRMC) studies, or the use of AI.

The "Test Summary" section explicitly states that the device's safety and performance were evaluated by lab bench testing according to various IEC (International Electrotechnical Commission) standards for electrical safety, electromagnetic compatibility, and photobiological safety, as well as software verification and validation. There is no mention of clinical trials, human data, expert ground truth, or any form of AI performance evaluation.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria, device performance from a clinical study, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC study results because this information is not present in the provided text.

The document primarily focuses on demonstrating equivalence through technical specifications and adherence to safety and performance standards for a light therapy device, not through clinical efficacy trials or AI performance evaluation.

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