(175 days)
The sensiLight™ Plus device is an over-the-counter device intended for the removal of unwanted hair. The sensiLight™/sensiLight™ Plus is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.
The sensiLight devices are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The sensiLight devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight devices is 3 cm². The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight will not trigger a pulse. (*) The sensiLight Plus model contains in addition, a movement sensor to prevent pulse overlapping.
The provided text is a 510(k) summary for the sensiLight/sensiLight Plus device, which is an over-the-counter device intended for the removal of unwanted hair and permanent reduction in hair regrowth. As such, it does not describe a study involving an AI algorithm and human readers, but rather a direct comparison of a new medical device to existing predicate devices to demonstrate substantial equivalence.
Therefore, many of the requested categories for AI/human reader studies are not applicable to this document. I will provide information based on what is available in the text.
Acceptance Criteria and Device Performance (Not directly applicable to AI/Human Reader Study, but to device equivalence)
The acceptance criteria for "permanent reduction in hair regrowth" is defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen. The document states that the sensiLight device underwent various tests to support its substantial equivalence to predicate devices, implying it meets this intended use.
| Acceptance Criteria (from Intended Use) | Reported Device Performance (as stated for substantial equivalence) |
|---|---|
| Permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen. | The document states: "EL Global Trade Ltd's sensiLight has been successfully tested through bench, usability and safety tests to support the determination of substantial equivalence with predicate devices." And "Tests results are supporting all labeling claims in order to establish substantial equivalency." This implies the device meets the performance requirements for permanent hair reduction, as substantial equivalence means it is as safe and effective as the predicate devices that already meet these claims. The device relies on the same technology (IPL), wavelength (475-1200 nm), and maximum energy (5 joules/cm²) as the predicate devices, which are already cleared for the same indication. |
1. Sample sized used for the test set and the data provenance:
The document does not provide details on the sample size for a test set related to hair regrowth efficacy or data provenance (e.g., country of origin, retrospective/prospective). It mainly focuses on technical specifications and safety testing to demonstrate substantial equivalence.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this document is not describing a study with human expert interpretation for device performance evaluation in the context of an AI/human reader study.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
4. 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. This document describes a medical device (IPL hair removal device), not an AI algorithm intended for interpretation by human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable, as this is a physical medical device and not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document implicitly relies on the established "ground truth" of comparable predicate devices that have already demonstrated efficacy for permanent hair reduction. Efficacy for hair removal devices is typically assessed through quantitative measurements of hair count reduction over time (outcomes data). However, specific details on how this "ground truth" was established for the sensiLight device's equivalence study are not provided. It mentions "bench, usability and safety tests."
7. The sample size for the training set:
Not applicable, as this is a physical medical device, not an AI algorithm requiring a training set.
8. 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.