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

Hair Removal Device (Model: R2815-G Pro, R2815-G), 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. The Hair Removal Device includes two models that are R2815-G Pro, R2815-G, and their indications for use, work principle, product structure and composition, electrical structure, performance and operation are basically the same, the only difference is that the R2815-G Pro is equipped with sapphire while R2815-G is not but with a metal treatment window surface. 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 activation is by finger switch.

The provided FDA 510(k) summary for the "Hair Removal Device, Model(s): R2815-G Pro, R2815-G" does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of clinical performance (e.g., hair removal efficacy). The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical comparisons, biocompatibility, electrical safety, eye safety, software verification, and usability.

Therefore, many of the requested details cannot be extracted from the given text.

Here's a breakdown of what can be inferred or stated as not present:

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

• Not explicitly provided for clinical performance. The document does not list quantitative acceptance criteria for hair removal efficacy (e.g., percentage reduction in hair growth) and then report clinical study results against them.
• Implied Acceptance Criteria for Safety and General Performance:
  • Biocompatibility: Pass tests as per ISO 10993-5, -10, -23. (Reported: Passed)
  • Electrical Safety & EMC: Pass tests as per IEC 60601-1, -1-2, -1-11, -2-83. (Reported: Passed)
  • Eye Safety: Pass tests as per IEC 62471. (Reported: Passed)
  • Software Validation: All software requirement specifications met, all software hazards mitigated. (Reported: Met)
  • Usability: Evaluated according to FDA guidance. (Reported: Evaluated)

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

• Not applicable/Not provided for clinical efficacy. The document does not describe a clinical test set or its sample size for evaluating hair removal. The "test set" mentioned in software validation refers to software testing, not human subjects.
• Data Provenance: The device manufacturer is Shenzhen Jianchao Intelligent Technology Co., Ltd. in China. The testing labs for biocompatibility, electrical safety, etc., are referred to as "reliable third-party lab(s)" but their specific location/country and data provenance (retrospective/prospective) are not detailed.

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. This information pertains to clinical studies involving expert assessment of outcomes, which is not detailed in this submission.

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

• Not applicable/Not provided. This information is relevant for clinical studies with subjective evaluation by multiple experts, which is not described here.

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 such study was done or reported. This device is an IPL hair removal device, not an AI-assisted diagnostic tool that would typically involve human readers.

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

• Not applicable. This question is also typically for AI diagnostic algorithms. For an IPL hair removal device, "standalone performance" refers to the device's physical and functional performance, which is addressed by the electrical, eye, and biocompatibility testing. The submission does not describe an "algorithm only" performance separate from the device itself.

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

• Not applicable for clinical efficacy. The "ground truth" for the non-clinical tests (biocompatibility, electrical safety) is defined by the standards themselves (e.g., a substance is biocompatible if it passes specific tests). There's no clinical "ground truth" established from pathology or outcomes data presented in this 510(k) summary.

8. The sample size for the training set

• Not applicable/Not provided. The device does not appear to involve a machine learning algorithm with a "training set" in the typical sense.

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

• Not applicable/Not provided. Same as above.

Summary of available "Performance Data" from the document:

The performance data supplied focuses on demonstrating that the device meets safety and basic functional requirements, aligning with recognized standards and FDA guidance, rather than presenting clinical efficacy data. The rationale for substantial equivalence is based on similar intended use, mode of action, and operational characteristics to predicate devices, supported by these non-clinical tests.

• Biocompatibility Testing:
  • Tests Performed: ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation).
  • Result: Passed all tests.
• Electrical Safety and EMC:
  • Standards Met: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83.
  • Result: Passed all tests.
• Eye Safety:
  • Standard Met: IEC 62471.
  • Result: Passed test.
• Software Verification and Validation:
  • Concern Level: Moderate.
  • Result: All software requirement specifications met, all software hazards mitigated.
• Usability:
  • Guidance Used: FDA's "Applying Human Factors and Usability Engineering to Medical Devices."
  • Result: Evaluated according to guidance.

The submission concludes that, "Based on the above performance as documented in this application, the Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate devices." This implies that by meeting these safety and functional standards, the device is considered as safe and effective as the predicates, without requiring a separate clinical efficacy study to establish new performance benchmarks for hair removal.

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