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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: KCA423, KCA437, KCA439), is an over-the-counter, homeuse 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 flash window and is suitable for multiple hair removal areas (such as: underarms, bikini lines, arms, legs, etc.). It contains a skin proximity 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. Models KCA437 and KCA439 have skin tone sensor to identify user's skin tone. Only user with suitable skin tone can use this device.

Based on the provided FDA 510(k) summary, here's an analysis of the acceptance criteria and the study proving the device meets them:

The document primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing against recognized standards rather than setting specific acceptance criteria for efficacy in the traditional sense of AI/algorithm performance. The "device" in question is an IPL Hair Removal Device, not an AI or algorithm. Therefore, many of the requested points regarding AI/algorithm-specific studies (like MRMC, standalone algorithm performance, training set details, ground truth establishment methods for algorithms) are not applicable.

The acceptance criteria here are derived from compliance with recognized medical device standards for safety and performance, and the "study" is the collection of tests performed to demonstrate this compliance.

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

Since this is an IPL hair removal device and not an AI/algorithm, "performance" is demonstrated through compliance with safety and performance standards. The acceptance criteria are implicit in meeting these standards.

• IEC 60601-1 (General requirements for basic safety and essential performance)
• IEC 60601-1-2 (Electromagnetic compatibility)
• IEC 60601-1-11 (Home Healthcare Environment)
• IEC 60601-2-83 (Particular requirements for home light therapy equipment) |
  | Eye Safety | Compliant with IEC 62471 (Photobiological safety of lamps and lamp systems). |
  | Software Verification and Validation (if applicable) | Consistent with moderate level of concern. System validation testing demonstrated all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
  | Usability | Evaluated and verified according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices." |
  | Functional Equivalence (e.g., energy density, wavelength) | Energy density: 2.45-5 J/cm² (Similar to predicate max 5 J/cm² and within reference 3-6 J/cm²).
  Wavelength range: 475-1200nm (Same as predicate 475nm-1200nm, similar to reference 510-1100nm).
  Pulse duration: 7-10ms (Similar to predicate 11-12ms and within reference 2-10ms).
  Other components/features: Similar source energy, power supply, product compositions, structure design, pulsing control, delivery device, number of output channels, skin proximity sensor, software/firmware/microprocessor control. |

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 implicitly refers to "testing" as a general practice for device compliance rather than a specific test set of patient data.

• Biocompatibility: Tests performed on materials.
• Electrical Safety, EMC, Eye Safety: Tests performed on the device itself.
• Software V&V: Validation of the software system.
• Usability: Evaluation of human interaction with the device.

There is no mention of a traditional "test set" of patient data for efficacy evaluation, nor details about its size, provenance (country), or whether it was retrospective or prospective. This type of detail is typically not required for an IPL device's 510(k) unless specific clinical efficacy claims beyond substantial equivalence without a predicate are being made or significant clinical differences from the predicate exist. The efficacy claims are tied to the predicate and the "Indications for Use" which defines permanent hair reduction based on measurements at 6, 9, and 12 months after treatment. However, no data from such an outcomes study is presented in this summary to support this specific device's 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 applicable. As this is not an AI/algorithm device requiring interpretation or ground truth establishment based on expert consensus for performance evaluation, there is no mention of experts or their qualifications for a test set.

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

Not applicable. There is no test set in the context of expert adjudication for this device type.

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 is not an AI-assisted diagnostic device.

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

Not applicable. This is not an AI/algorithm.

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

For the compliance aspects:

• Biocompatibility: Ground truth is established by the results of standardized biological tests (cytotoxicity, irritation, skin sensitization) against ISO 10993 criteria.
• Electrical Safety, EMC, Eye Safety: Ground truth is established by meeting the requirements of the referenced IEC standards.
• Software V&V: Ground truth is against the defined software requirements and risk mitigation strategies.
• Usability: Ground truth is derived from adherence to human factors and usability engineering principles and guidance.

For the Indications for Use regarding "permanent reduction in hair regrowth," the ground truth would typically come from outcomes data (measurements of hair regrowth at specific time points after treatment). However, the 510(k) summary provided does not include such outcomes data for the subject device, instead relying on substantial equivalence to the predicate device which presumably did provide such data.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable. This is not an AI/algorithm device that requires a training set.

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The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne.

The Beauty LED Mask adopts light emitting diodes (LED) in the red (637nm ± 5nm) + infrared (854nm ± 5nm) and blue (465 ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect. The Beauty LED Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). Power adapter is provided to charge the battery contained in the controller. To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, Beauty LED Mask has incorporated protective eye-shield which blocks light energy from LEDs.

The provided document is a 510(k) summary for the Beauty LED Mask, Model: KFB265. It outlines the device's characteristics and its substantial equivalence to a predicate device, but it does not contain information about clinical studies or specific acceptance criteria and performance data related to its effectiveness in treating wrinkles and acne.

The document primarily focuses on:

• Regulatory classification and product codes.
• Comparison of technological characteristics with predicate devices (e.g., light source, wavelength, power supply, dimensions).
• Compliance with non-clinical standards, such as electrical safety (IEC 60601 series, IEC 62133-2), photobiological safety (IEC 62471), and biocompatibility (ISO 10993 series).
• Software verification and validation.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for clinical outcomes.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used (clinical outcomes, pathology, etc.).
• Sample size and ground truth establishment for a training set.

The document states that "Non-clinical testings have been conducted to verify that the Beauty LED Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device." This indicates that the 510(k) clearance was based on demonstrating equivalence in non-clinical technical characteristics and safety, rather than requiring new clinical performance data for effectiveness.

In summary, the provided text describes a regulatory submission based on substantial equivalence to a predicate device through non-clinical testing, not a study proving clinical effectiveness against specific acceptance criteria.

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