(60 days)
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.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility | Compliant with ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization) for all user directly contacting materials. |
| Electrical Safety and EMC | Compliant with: |
- 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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.