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The LED Therapy Device is intended for hair removal, permanent hair reduction on all skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The LED Therapy Device is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a diode LED as a light source (780-850 nm). The LED light power is delivered to the treatment area via a LED hand piece. The emission LED is activated by a foot switch and a hand piece.

The proposed LED Therapy Device is equipped with a light depilation function that is based on the theory of selective photo thermolysis. There is abundant melanin in the hair follicle and hair stem. The melanin is distributed amidst the cells between the hair ball substrate and it can be transferred to the structure of hair stems (such as medulla, cortex, and hair cuticle). The Near infrared light can precisely target the melanin and apply the depilation treatment selectively. After the melanin absorbs Near infrared light energy, the temperature rises, in this way, the surrounding hair follicle tissues are damaged, and the hairs are removed.

The provided text is a 510(k) summary for the Shenzhen Leaflife Technology Co., Ltd's LED Therapy Device. It details the device's characteristics and compares them to predicate devices, but it explicitly states that "No clinical study is included in this submission."

Therefore, I cannot provide information regarding acceptance criteria and a study proving the device meets those criteria, as no such study is presented in the document.

Here's what I can extract based on the provided text, primarily about the technical specifications and comparison:

1. A table of acceptance criteria and the reported device performance:

Since no clinical study with acceptance criteria is provided, I cannot create such a table for performance against clinical endpoints. However, the document does compare technical characteristics to predicate devices. Here's a table focusing on the technical characteristics comparison, noting where they are "Same," "Similar," or "Discussion" (implying a difference that the manufacturer argues does not impact substantial equivalence):

2. Sample sized used for the test set and the data provenance:
Not applicable as no clinical study or test set for performance evaluation is mentioned. The non-clinical tests mentioned are for safety and technical standards compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical study or ground truth for performance evaluation is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no clinical study or test set for performance evaluation is mentioned.

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 as no clinical study, MRMC study, or AI component is mentioned. This is a physical LED therapy device, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is a physical LED therapy device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable as no clinical study or ground truth for performance evaluation is mentioned. Non-clinical tests were conducted to verify compliance with safety and electrical standards.

8. The sample size for the training set:
Not applicable as no clinical study or AI model requiring a training set is mentioned.

9. How the ground truth for the training set was established:
Not applicable as no clinical study or AI model requiring a training set is mentioned.

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