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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.

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

• OTC Usability Study: A total of 20 participants were enrolled in this study.
• Data Provenance: Not specified, but likely associated with the manufacturer (Lumenessa Corp) and its R&D activities, potentially in China (where the correspondent is located). The study is described as a "Company" study. It's a prospective study designed to gather user feedback.
• Other Testing (Biocompatibility, Electrical Safety, Eye Safety): These were standard lab bench tests against recognized international standards (ISO, IEC). The "sample size" here refers to the materials or prototypes tested, which is not numerically specified but implied as adequate to meet the standard requirements.

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

• OTC Usability Study: This study focused on user understanding and operation, not on establishing a "ground truth" for a medical condition. It mentions gathering data from "layperson" participants. No medical experts were explicitly involved in this usability study for ground truth establishment.
• Other Testing: These involved adherence to established engineering and safety standards. Experts would be engineers and lab technicians ensuring compliance, but not in the context of clinical "ground truth" for disease.

4. Adjudication method for the test set:

• OTC Usability Study: The document states the study "was completed successfully and the results were no issues or negative comments." This implies a qualitative assessment of user feedback rather than a formal adjudication process (like 2+1 or 3+1 consensus).
• Other Testing: Adjudication is not applicable as these are compliance tests against objective standards.

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. This device is an IPL hair removal device, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related performance metrics are not applicable and were not conducted or reported.

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

• No. This is not an AI algorithm device. Performance is based on mechanical, electrical, optical and safety specifications.

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

• For the OTC Usability Study, the "ground truth" was about user comprehension and successful operation of the device by laypersons, rather than a clinical diagnosis. The outcome (no issues or negative comments) served as the "ground truth" regarding usability.
• For technical performance and safety tests, the "ground truth" was adherence to established international and national standards (ISO, IEC) for medical devices. This is an engineering ground truth, not a clinical one.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the machine learning sense.

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

• Not applicable. As there is no training set, there is no ground truth establishment for it.

In summary: The provided document is a 510(k) submission for a non-AI, over-the-counter IPL hair removal device. The acceptance criteria and "studies" described focus on demonstrating the device's technical specifications comply with recognized safety standards and that it is substantially equivalent to existing predicate devices, along with a basic usability study for laypersons. It does not provide information relevant to AI diagnostic performance, clinical ground truth establishment, or multi-reader studies.

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