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Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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.

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with a lamp that can emit single pulse, double pulse or triple pulse per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

Based on the provided FDA 510(k) clearance letter for the Ice Cooling IPL Hair Removal Device, here's a breakdown of the acceptance criteria and the study (performance data) that proves the device meets them:

Important Note: The provided document is an FDA Clearance Letter and a 510(k) Summary. These documents primarily focus on demonstrating substantial equivalence to predicate devices and detailing the safety and performance testing that supports this claim. They do not contain detailed clinical study results such as those typically found in a clinical trial report (e.g., specific hair reduction percentages, statistical significance, or details on human reader studies for AI). The performance data listed focuses on engineering and safety standards, not clinical efficacy metrics with human subjects.

Therefore, for aspects related to clinical efficacy (like "how much human readers improve with AI vs without AI assistance" or detailed ground truth establishment for a clinical outcome), the information below is derived from what can be inferred or is explicitly stated regarding the device's technical specifications and safety profile, rather than a direct clinical performance study with defined acceptance criteria for efficacy. The "acceptance criteria" primarily relate to safety, electrical performance, and biocompatibility, as evidenced by compliance with international standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an IPL hair removal device, the "acceptance criteria" in this context are primarily related to safety, electrical performance, and biocompatibility standards, rather than direct efficacy metrics like those for an AI diagnostic device. Efficacy is typically established by comparing the device's operational characteristics and intended use to legally marketed predicate devices that have prior clearance for similar indications, and by showing that it achieves the "permanent reduction in hair regrowth" as stated in the Indications for Use. The "reported device performance" is then the successful demonstration of compliance with these standards and comparable technological characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a sample size for a clinical test set for hair reduction efficacy or any "test set" in the context of an AI/algorithm-driven diagnostic device. The performance data is primarily focused on engineering and safety testing conducted to established international standards.

• Sample Size for Testing: Not applicable in the context of a clinical test set for efficacy, as no such study is detailed. For electrical and biocompatibility testing, "samples" would refer to a statistically appropriate number of units or materials for the specified tests, but these numbers are not disclosed.
• Data Provenance: The manufacturer is Shenzhen Ulike Smart Electronics Co., Ltd., located in Shenzhen, China. The testing standards are international (IEC, ISO). The nature of the studies discussed (biocompatibility, electrical safety, light safety, software V&V, Usability) are laboratory-based and engineering assessments, not multi-center clinical trials. There is no indication of retrospective or prospective clinical data from human subjects mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable or provided in the context of the 510(k) summary for an IPL hair removal device. "Ground truth" established by experts (e.g., radiologists) is typically relevant for diagnostic devices that analyze medical images or data. For this device, "ground truth" for safety specifications is established by compliance with published international standards (IEC, ISO), and human factors/usability experts would likely assess the usability aspects. No details are given about such experts or their roles in establishing a "ground truth" for clinical efficacy.

4. Adjudication Method for the Test Set

Not applicable/provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies for diagnostic devices, especially when establishing ground truth from multiple expert readers. This type of clinical study is not detailed in the provided 510(k) summary for this device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done according to the provided 510(k) summary. MRMC studies are specific to evaluating the diagnostic performance of algorithms (often AI) in conjunction with human interpretation, and assessing the improvement in human reader performance with AI assistance. This device is an IPL hair removal device, not a diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device does contain software ("Software Verification and Validation" is listed as a performance data category), this is embedded control software for the device's functionality (e.g., controlling pulse emission, energy levels, safety features like the skin sensor). There is no indication of a "standalone" algorithm performance study in the sense of an AI model independently performing a diagnostic task without human interaction. The software functions to ensure the device operates safely and effectively as designed, not to perform an independent diagnostic or analysis function typically evaluated in a standalone study.

7. The Type of Ground Truth Used

For the technical and safety performance, the "ground truth" is adherence to established international standards (IEC, ISO). For example:

• Biocompatibility: In vitro and in vivo test results against material safety standards.
• Electrical Safety & EMC: Measurements of electrical parameters and electromagnetic emissions against IEC limits.
• Light Safety: Measurements of light output parameters against IEC limits for photobiological safety.
• Software V&V: Verification that software functions as specified and validation that it meets user needs/hazard mitigation requirements.
• Usability: Observational and empirical data from user testing against usability standards and FDA guidance.

For clinical efficacy (hair reduction), the ground truth would inherently be a measured reduction in hair regrowth over time, typically observed by clinicians or participants. However, the document does not describe the detailed clinical study methodology (e.g., type of outcome data, how it was collected, or if it involved pathology/histology to confirm hair follicle damage) that would have been used to establish this clinical "ground truth" for the device, beyond stating the "permanent reduction in hair regrowth" as an indication for use, implying it was demonstrated previously by predicate devices.

8. The Sample Size for the Training Set

Not applicable/provided. The concept of a "training set" is relevant for machine learning or AI models. This 510(k) summary describes a physical medical device (an IPL hair removal device), not an adaptive AI system requiring a training data set for its primary function. While the device contains software, it's for control and safety, not for learning or diagnostic predictions from historical data.

9. How the Ground Truth for the Training Set Was Established

Not applicable/provided. As there is no "training set" in the context of an AI/ML algorithm discussed, the establishment of ground truth for such a set is not relevant to this 510(k) submission.

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