(81 days)
The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
The sensiLight Mini device is a 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 Mini device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight Mini device 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 Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight Mini will not trigger a pulse.
This document is a 510(k) premarket notification for the sensiLight Mini, which is a pulsed light hair removal device. The device described in this submission (K161089) is stated to be identical to a previously cleared device (K140527). Therefore, no new performance data, non-clinical data, or clinical data are reported in this specific submission. The substantiation relies on the data from the predicate devices.
However, based on the information provided, we can infer some details about the clinical performance for the original device that K161089 references (K140527), particularly regarding its "permanent reduction in hair regrowth" claim.
Here's an attempt to answer your questions based on the available information and reasonable inferences:
1. A table of acceptance criteria and the reported device performance
Since this submission explicitly states "No new clinical performance data is reported in this submission" and "The sensiLight Mini device is identical in all details to the sensiLight Mini device cleared under K140527," the acceptance criteria and performance would be associated with the original K140527 submission. The document defines "permanent reduction in hair regrowth" as:
| Acceptance Criteria (Implied for K140527) | Reported Device Performance (Implied for K140527) |
|---|---|
| Long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen. | (Details not provided in this specific K161089 document, but the device was cleared based on meeting this definition.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the K161089 document as it refers back to a previous submission (K140527). To obtain these details, one would need to consult the K140527 submission.
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)
This information is not provided in the K161089 document. Clinical studies for hair removal devices often involve trained technicians or physicians for evaluation, but specifics are missing here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the K161089 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
Hair removal devices like the sensiLight Mini are typically consumer-use devices and do not involve "readers" in the context of diagnostic imaging. Therefore, an MRMC study and AI assistance as described are not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a physical light-based hair removal device for consumer use, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device's performance is inherently tied to human use and application according to instructions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For hair removal studies of this nature, the "ground truth" for efficacy (hair reduction) is typically established by outcomes data in the form of objective measurements of hair count or hair density in treated vs. untreated areas, often performed by trained personnel or experts following a standardized protocol. This would be observed at specified time points (6, 9, and 12 months as indicated by the definition).
8. The sample size for the training set
The device described is a physical medical device, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. Therefore, a "training set" as it applies to AI/ML is not applicable. Its development would involve engineering, safety, and clinical testing, not algorithmic training.
9. How the ground truth for the training set was established
As explained in point 8, the concept of a "training set" with ground truth establishment for an AI/ML algorithm is not applicable to this device.
§ 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.