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The product is an over-the-counter device intended for removal of unwanted body and facial hair.

IPL hair removal device is a personal, light-based, hair reduction device intended to be sold over-thecounter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and a skin tone sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

The IPL hair removal device includes LS101 and LS102 two models. Their intended use, performance, structure design and operation are identical, with the different color of grip part. The difference does not affect or change the intended use of the device.

The provided document is a 510(k) Premarket Notification for an IPL hair removal device. It focuses on demonstrating substantial equivalence to predicate devices based on technical specifications and safety standards, rather than clinical performance or AI/software-based diagnostics. Therefore, much of the information requested, particularly regarding acceptance criteria for diagnostic performance, AI study details, expert review, and ground truth establishment in a medical imaging context, is not present in this document.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not define explicit "acceptance criteria" in the sense of a clinical trial or AI model performance metrics (like sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices by confirming the subject device meets the same safety and performance standards.

The table below summarizes the comparison elements used to demonstrate substantial equivalence, which implicitly act as performance criteria for the device's technical specifications. The "Reported Device Performance" column reflects the subject device's specifications.

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Home Use IPL Beauty Device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs.

The Home Use IPL Beauty Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using IPL technology. Of which, the Device includes MELSYA-M5 and MS-206B two models. Both have adopted the same structure design, consisting of Hair removal device main body and power adapter two parts, and a hair removal lamp located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is power from power adapter via an external power.

The difference of MELSYA-M5 and MS-206B two models is mainly the exception of appearance and spot size (the size of treatment window) which do not affect the intended use. The spot size of MELSYA-M5 is 3.9cm² and MS-206B is 3.0 cm², as well as the energy density of the both models is 5.5 J/cm2.

The provided text is a 510(k) summary for the "Home Use IPL Beauty Device" and details its substantial equivalence to predicate devices. It covers various performance data but does not include a table of acceptance criteria and reported device performance for a hair removal efficacy study.

Here's an analysis of the available information:

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

• Not provided in the document. The document discusses various safety and usability tests but does not present acceptance criteria or reported performance for hair removal efficacy directly. It broadly states, "Performance data supports that the device is safe and as effective as the predicate device for its intended use," but no specific metrics for hair removal are given in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Test set for OTC Usability Study: A total of 20 participants were enrolled.
• Data Provenance: Not explicitly stated for the usability study. The manufacturer is Shenzhen Mismon Technology Co., Ltd, 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 / Not provided. The "OTC Usability Study" focused on layperson understanding of labeling, not on establishing a ground truth for device performance by experts.

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

• Not applicable / Not provided. For the usability study, the focus was on gathering data from participants regarding their understanding, not on adjudication of results by experts.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a hair removal device, not an AI-powered diagnostic or imaging device where such a study would typically be performed.

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

• Not applicable. This device is a direct-use consumer product, not an algorithm.

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

• For the OTC Usability Study: The "ground truth" was related to whether participants understood the labeling and how the device works, measured by their responses and comments. This is a form of user feedback/understanding data, not clinical ground truth in the traditional sense of efficacy.

8. The sample size for the training set:

• Not applicable / Not provided. This document does not describe a machine learning model with a training set.

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

• Not applicable / Not provided. As there is no mention of a machine learning model or training set, this information is not relevant to the provided text.

In summary, the document details safety and usability testing, but does not provide specific performance data or a structured study on hair removal efficacy with acceptance criteria. Its primary focus for performance data mentioned is on biocompatibility, electrical safety, eye safety, software verification, and OTC usability, all of which were reported as "passed" or "completed successfully" without issues.

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