(85 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: UI06 PL, UI06 PN, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD), is an over-the-counter, home-use and personal 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 sapphire treatment window and the spot size is 3.3cm2 that is suitable for multiple hair removal areas. 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 document is a 510(k) Summary for an IPL Hair Removal Device (K223618). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone clinical study with detailed acceptance criteria and performance metrics for the device's hair removal efficacy.
Therefore, the following information cannot be fully provided based on the given text:
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A table of acceptance criteria and the reported device performance for hair removal efficacy: The document states the device is indicated for "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." However, it does not provide specific numerical acceptance criteria (e.g., "X% reduction in hair regrowth") or reported performance data from a primary efficacy study for the subject device. The comparison table (page 5) lists "Indication for use/Intended use" which is descriptive but not a performance metric.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) for hair removal efficacy: No information about a clinical study's test set for hair removal efficacy is provided.
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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 information would be relevant to a clinical study assessing efficacy, which is not detailed in the document.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as a clinical efficacy study with ground truth adjudication is not described.
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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 diagnostic tool that human readers would use.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc) for hair removal efficacy: Not detailed for hair removal efficacy.
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The sample size for the training set: Not applicable, as this is not an AI/ML algorithm that requires a training set in the sense of predictive modeling.
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How the ground truth for the training set was established: Not applicable.
The document primarily focuses on non-clinical performance data for safety (biocompatibility, electrical safety, EMC, eye safety), software verification, and usability. It concludes that the device is "as safe, as effective, and performs as well as the legally marketed predicate devices and reference device" based on a comparison of technological characteristics and these non-clinical tests.
Acceptance Criteria and Study Details (Based on available information)
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, specific numerical acceptance criteria for hair reduction efficacy are not provided in this document. The document primarily focuses on demonstrating safety and general performance equivalence to predicates through compliance with various standards.
| Category | Acceptance Criteria | Reported Device Performance and Compliance |
|---|---|---|
| Hair Removal Efficacy | 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 (This is the indication for use, not a specific numerical acceptance criterion provided for the subject device). | Not explicitly stated with primary data for the subject device. The statement is that the subject device has "the same intended use" and "similar operational characteristics" as predicate devices, and "Any minor differences... do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices and reference device for its intended use." |
| Biocompatibility | Compliance with ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization) standards. | Passed ISO 10993-5:2009 and ISO 10993-10:2010. |
| Electrical Safety | Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, and IEC 60601-2-83 standards. | Passed all listed electrical safety and EMC standards. |
| Eye Safety | Compliance with IEC 62471 (Photobiological safety of lamps and lamp systems) standard. | Passed IEC 62471. |
| Software V&V | Software documentation consistent with moderate level of concern; all software requirement specifications met; all software hazards mitigated to acceptable risk levels. | All software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
| Usability | Evaluation and verification according to IEC 60601-1-6 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices". | The product usability has been evaluated and verified according to the listed standard and FDA guidance. |
2. Sample size used for the test set and the data provenance (for hair removal efficacy)
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The document relies on equivalence to previously cleared devices rather than providing primary clinical data for the subject device's efficacy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as no clinical efficacy study with ground truth assessment is described for the submitted device.
4. Adjudication method for the test set
- Not applicable.
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 diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For efficacy related to hair reduction, the document refers to the definition of permanent reduction (long-term, stable reduction in hair regrowth measured at 6, 9, and 12 months), but does not describe a study where this ground truth was established for the subject device. It hinges on the predicate devices having already met this.
- For safety (biocompatibility, electrical safety, eye safety), the ground truth is established by meeting the specific requirements and passing the tests outlined in the referenced international standards (e.g., ISO 10993, IEC 60601 series, IEC 62471).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that learns from a training set. The "software" mentioned refers to embedded control software, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.