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This device produces light in the blue light (415mm) is intended to reduce mild to moderate inflammatory acne vulgaris. The red light (635mm) in combination with near-infrared light (850mm) is intended to improve the appearance of wrinkles.

The Bestqool LED therapy devices, available in models LMK-001, LMK-004, LMK-005, and LMK-006, differ only in their appearance color to cater to user preferences. The device is designed as a foldable arch shape and is equipped with 200 LED beads. Despite the color variations, the device structure and functional parameters remain identical across all models,which uses specific wavelengths of light to manage aesthetic conditions. This device does not come into contact with the body; users should lie under the device treatment area during use.The device is powered by an AC adapter. This device produces light in the blue light (415nm) is intended to reduce mild to moderate inflammatory acne vulgaris. The red light (635nm) in combination with near-infrared light (850nm) is intended to improve the appearance of wrinkles.

This document is a 510(k) summary for the Bestqool LED Therapy Device. It details the device's indications for use, its comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate its safety and effectiveness.

Based on the provided information, the device is an LED Therapy Device (Bestqool LED Therapy Device (LMK-001, LMK-004, LMK-005, LMK-006)) and the submission is a 510(k) Premarket Notification.

Here's an analysis addressing your questions, keeping in mind that this is a 510(k) summary and not a full study report. Therefore, some specific details might be summarized or omitted in this document.

Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K200983) by showing similar technological characteristics and performance that does not raise new questions of safety and effectiveness. The acceptance criteria are implicitly tied to meeting the performance characteristics demonstrated by the predicate device and relevant safety standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in a quantified table with corresponding "reported device performance" in a manner typical for clinical trials or comprehensive performance testing. Instead, it relies on demonstrating similarity to a predicate device and adherence to recognized safety standards. However, we can infer some criteria and reported performance from the "Predicate Device Comparison" table and "Summary of Non-Clinical Performance Testing".

Study Details (as inferred from a 510(k) Summary):

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

• Sample size: The document explicitly states "Clinic test: N/A". This means no clinical study (human subject test set) was conducted for this 510(k) submission to prove the device meets acceptance criteria. The approval is based on substantial equivalence to a predicate device, supported by bench testing and adherence to recognized standards.
• Data provenance: Not applicable, as no clinical test set was used. The non-clinical testing was likely performed by the manufacturer, Dongguan Laiguang Electronic Technology Co.,Ltd. in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable. Since no clinical test set was used, there was no ground truth to establish by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No clinical test set.

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 an LED therapy device, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

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

• Not applicable. This is a light-emitting therapeutic device, not an algorithm. Its "performance" is its ability to emit light at specific wavelengths and intensities for a duration, which was verified through bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the non-clinical performance testing (wavelength, irradiance, dose), the "ground truth" would be established by validated measurement equipment and calibration standards. For safety and EMC, it's compliance with the specific parameters and limits defined in the referenced IEC standards.
• No clinical ground truth (e.g., patient outcomes, clinical assessments of acne or wrinkles) was established for this submission, as clarified by "Clinic test: N/A".

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning device, so there is no "training set."

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

• Not applicable. No training set.

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