(58 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: 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.
§ 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.