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Hand-held Hair Removal Device 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.

Hand-held Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eight models with the same IPL technology for hair removal, which is model FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09. The device 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 Hand-held Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.0cm² (Model BFZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) that is suitable for multiple hair removal areas, such as upper lip, chin, underarms, legs, arms, bikini area, chest, back, abdomen.

The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the Hand-held Hair Removal Device has the cooling function (suitable for model CT05, CT06, CT07, CT08, CT09), which can be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.

The provided 510(k) summary for the "Hand-held Hair Removal Device" does not contain any information about acceptance criteria or a study proving that the device meets specific performance criteria related to hair removal efficacy.

The document focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and compliance with various safety and regulatory standards.

Here's a breakdown of why I cannot fulfill your request for acceptance criteria and a study proving device performance based on the provided text, and what information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Available: The document does not list any quantitative acceptance criteria for hair reduction or removal efficacy. It also does not report any device performance metrics related to hair removal (e.g., percentage of hair reduction after a certain number of treatments, hair count at 6, 9, or 12 months).
• What is available: The document states the "Indications for Use" which defines "permanent reduction in hair regrowth" as a "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." However, it doesn't provide data to show if or how much reduction was achieved by this specific device.

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

• Not Available: There is no mention of a clinical test set used to evaluate the device's hair removal efficacy. Therefore, sample size and data provenance are not reported.
• What is available: The document lists various safety and electrical performance tests (Biocompatibility Evaluation, Electrical Safety and EMC, Eye Safety, Software Verification and Validation, Usability), but these are not for efficacy.

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

• Not Available: Since no clinical efficacy study is described, there is no mention of experts establishing ground truth for efficacy.

4. Adjudication Method for the Test Set:

• Not Available: Not applicable as no clinical efficacy study is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not Available: This type of study is not mentioned. The document focuses on demonstrating equivalence to predicate devices, not on comparing performance with or without AI assistance for human readers (which is relevant for diagnostic devices, not typically for hair removal devices).

6. Standalone Performance Study:

• Not Available: While the document mentions "Performance Data," it refers to non-clinical tests (biocompatibility, electrical safety, eye safety, software, usability). There is no standalone clinical performance study data presented for the actual hair removal efficacy of the device.

7. Type of Ground Truth Used:

• Not Available: As no clinical efficacy study is described, no ground truth for hair removal efficacy is mentioned.

8. Sample Size for the Training Set:

• Not Available: Since there's no mention of a machine learning or AI component for efficacy (only general "Software Verification and Validation"), there is no "training set" in the context you're asking about (i.e., for learning to perform hair removal or analyze its results).

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

• Not Available: Not applicable, as no such training set is mentioned.

In summary:

The 510(k) summary provided indicates that the "Hand-held Hair Removal Device" is being cleared based on its substantial equivalence to existing predicate devices in terms of intended use, technological characteristics, and compliance with general safety and electrical standards. It does not present specific clinical performance data, acceptance criteria for efficacy, or studies demonstrating the device's hair removal performance. The emphasis is on showing that it is as safe and effective as previously cleared devices based on similarity and non-clinical testing, rather than providing novel clinical trial data for its hair reduction capabilities.

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Intense Pulse Light Therapeutic Apparatus is an over-the-counter device intended for removal of unwanted body hair.

The Intense Pulse Light Therapeutic Apparatus 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 Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.The Intense Pulse Light Therapeutic Apparatus is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse.There are IPL-18 BF and IPL-18 FG two models in this application. Their work principle, intended use, structure, appearance, size, and composition are the same, with differences being product function are slight differences, but these parameters are within the predicate device and do not affect or change the intended use of the device.

The FDA 510(k) summary for the Intense Pulse Light Therapeutic Apparatus (K242595) does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria for its intended use (removal of unwanted body hair).

Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: The device shares the same intended use as its primary predicate: "removal of unwanted body hair."
• Operational Characteristics and Design: The summary compares various physical and technical characteristics (wavelength range, energy density, pulse duration, light source, etc.) to show similarities or non-significant differences with predicate devices.
• Compliance with Recognized Standards: The substantial equivalence is supported by showing compliance with a suite of international standards related to biocompatibility, electrical safety, electromagnetic compatibility (EMC), photobiological safety, and software verification/validation.

Here's an breakdown of the available information based on your request:

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

The document does not provide specific quantitative acceptance criteria for hair removal effectiveness (e.g., X% hair reduction after Y treatments) or reported performance data against such criteria. The reported performance is implicitly deemed acceptable by virtue of:

• Substantial Equivalence to Predicate Devices: The key "acceptance criterion" here is that the subject device's characteristics and safety/effectiveness profile are comparable enough to legally marketed predicate devices.
• Compliance with Safety Standards: Meeting standards for biocompatibility, electrical safety, EMC, and photobiological safety is presented as the primary performance data.

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

The document does not describe a clinical test set with human subjects to evaluate hair removal efficacy. The "test set" in this submission refers to the components and systems subjected to engineering (biocompatibility, electrical safety, EMC, etc.) and software validation testing. The data provenance for these engineering tests is generally from the manufacturer's testing or accredited labs, not specific countries or patient populations.

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)

This section is not applicable as there is no clinical test set for efficacy evaluation described in the submitted 510(k) summary. The "ground truth" for the engineering tests would be the specifications and requirements of the relevant IEC and ISO standards. The experts involved would be the engineers and quality personnel conducting the tests and verifying compliance. Their specific qualifications are not detailed in this summary.

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

This is not applicable as there is no clinical test set requiring adjudication in this 510(k) summary.

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

This is not applicable as the device is an Intense Pulse Light Therapeutic Apparatus for hair removal, which is not an AI-powered diagnostic device requiring human reader interpretation. No MRMC study was performed or is relevant.

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

This is not applicable as the device is a physical light therapy apparatus, not an algorithm. Performance is demonstrated through compliance with safety and engineering standards and comparison of physical and operational characteristics to predicate devices.

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

For the compliance testing:

• Biocompatibility, Electrical Safety, EMC, Eye Safety: The "ground truth" is compliance with the specified international standards (ISO 10993 series, IEC 60601 series, IEC 62471). This means the device met the predefined thresholds and requirements set out in these widely accepted safety and performance standards.
• Software Verification and Validation: The "ground truth" is that the software met its specified requirements and mitigated identified hazards, as demonstrated through validation testing against defined specifications.

There is no "ground truth" for hair removal efficacy (e.g., pre/post treatment hair counts, subject satisfaction scores, expert assessment of hair reduction) presented in this 510(k) summary.

8. The sample size for the training set

This is not applicable. The device is an Intense Pulse Light Therapeutic Apparatus. It is not an AI/ML algorithm that requires a training set. The "design" and "development" of the device would involve engineering prototypes and testing, but not in the context of a "training set" as it would apply to AI.

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

This question is not applicable as the device is not an AI/ML system requiring a training set with established ground truth.

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