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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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Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.

Hair Removal Device (Model: R3C16-P, R3C16-G; R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro), is an over-the-counter, home-use and personal device for hair reduction based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. Hair Removal Device includes two series (R3C16 series) with a total of 10 models. The two series products adopt identical intended use, similar performance and operation, consisting of IPL host and power adapter, which the host is mainly composed of lamp tube, filter, display screen, buttons, thermoelectric cooler, fan, and DC socket. The device is only powered by the external power adapter. The device is fitted with a skin sensor to detect appropriate skin contact, if the treatment window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission is by manual finger switch or auto light emission. All models of the Hair Removal Device have a cooling function for a better hair removal experience, but the main difference is that the model with "Pro" in the model name is equipped with sapphire while the model without "Pro" uses metal treatment window surface.

This 510(k) summary provides limited information regarding specific acceptance criteria and detailed study results for the Hair Removal Device. However, based on the provided text, here's an analysis of what can be extracted.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with corresponding reported device performance values. Instead, it relies on a comparison to predicate devices and adherence to various safety and performance standards.

We can infer the intent of some acceptance criteria by looking at the "Comparison Elements" table on pages 7-8 and the "Non-Clinical Testing" section on page 9. The underlying acceptance is that the subject device's characteristics and performance are "similar" or "same" to the predicate devices and meet the specified international standards for medical electrical equipment and photobiological safety.

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

The document explicitly states "VIII. Clinical Testing: Not applicable."
This means there was no clinical test set for evaluating the device's hair removal efficacy and safety on human subjects as part of this 510(k) submission. Therefore, details like sample size, country of origin, or retrospective/prospective nature are not provided for efficacy testing.

The "non-clinical testing" mentioned primarily refers to bench testing and adherence to international safety and performance standards for medical devices and photobiological safety. For these tests, specific sample sizes (e.g., number of devices tested for electrical safety, materials tested for biocompatibility) are typically defined by the respective standards, but these details are not provided in this summary.

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

Since no clinical testing was applicable or performed for this 510(k) submission, there was no clinical test set for which ground truth needed to be established by experts for efficacy. The evaluation was based on non-clinical characteristic comparisons and technical standard compliance.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication for ground truth was performed.

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

No. The document explicitly states "VIII. Clinical Testing: Not applicable." An MRMC study would be a type of clinical comparative effectiveness study, which was not done.

6. Standalone Performance Done

The performance evaluation in this 510(k) is primarily a standalone assessment of the device's technical specifications and compliance with safety standards. The comparison to predicates is to demonstrate "substantial equivalence" based on similar characteristics and the device meeting the same technical and safety requirements. The non-clinical tests (e.g., biocompatibility, electrical safety, photobiological safety) are assessments of the device itself (standalone).

7. Type of Ground Truth Used

Given the "Clinical Testing: Not applicable" statement, there was no clinical "ground truth" related to hair removal efficacy established or used in this submission. The "ground truth" for the non-clinical tests would be the requirements and limits defined by the referenced international standards (e.g., IEC, ISO standards). For example, the ground truth for cytotoxicity testing is whether the material shows cytotoxic effects according to the criteria in ISO 10993-5.

8. The Sample Size for the Training Set

Not applicable. The device is a hardware product for hair removal, not an AI/ML algorithm that requires a training set in the typical sense. The "software/firmware/microprocessor control" mentioned refers to embedded control systems for device operation (e.g., intensity levels, safety features), not for learning or diagnostic purposes that would require a large training dataset.

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

Not applicable, as there is no mention of an AI/ML algorithm training set.

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IPL 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.

IPL Hair Removal Device (Model: UI04A, UI04B, UI04C), is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL). 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. This product adopts irreplaceable treatment window and is suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). 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 cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.

The provided text is a 510(k) Summary for an IPL Hair Removal Device. It details the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence. However, it does not contain a study proving the device meets specific acceptance criteria related to its primary intended use (hair removal/reduction effectiveness). The "Performance Data" section focuses on safety and regulatory compliance aspects, not clinical performance for efficacy.

Therefore, many of the requested items cannot be extracted from the provided text.

Here is an attempt to answer the questions based on the available information:

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

The document does not provide specific acceptance criteria or reported device performance for hair removal efficacy. The "Performance Data" section focuses on demonstrating compliance with safety standards and biocompatibility.

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

Not provided in the document. The document refers to "usability evaluation has been conducted to verify these skin types can use the device safely and effectively," but does not detail the study design, sample size, or data provenance for this evaluation, nor does it provide the results for hair removal efficacy.

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 provided in the document.

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

Not provided in the document.

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. This device is an IPL hair removal device, not an AI-assisted diagnostic tool that would typically involve a multi-reader, multi-case study for diagnostic accuracy.

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

This refers to the performance of the device itself. While there is no detailed efficacy study presented, the statement "usability evaluation has been conducted to verify these skin types can use the device safely and effectively" implies some form of standalone evaluation was performed. However, the details of what was measured for "effectively" in terms of hair reduction are missing, as are the quantitative results.

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

Not explicitly stated for efficacy outcomes. For safety evaluations (biocompatibility, electrical safety, eye safety), the ground truth is established by adherence to recognized international standards and passing criteria within those standards. For the usability evaluation, the "ground truth" would likely be subjective user feedback and expert observation, but no details are provided.

8. The sample size for the training set

Not provided, as this is not an AI/algorithm training scenario as commonly understood for this question.

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

Not applicable for a training set in this context.

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