(149 days)
The sensiLight Mini is an over the counter devices 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 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.
The provided document describes the sensiLight Mini, a pulsed light hair removal device. However, it does not include specific acceptance criteria or a study that directly proves the device meets those criteria in the typical sense of a clinical trial with predefined endpoints and statistical analysis.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and comparisons of technological characteristics. The "Performance Data" section primarily lists compliance with recognized standards and non-clinical testing.
Here's an attempt to extract and synthesize the requested information based on the provided text, acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria with numerical targets are not stated, I will infer them from the safety and usability tests described and the claim of "substantial equivalence."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety: | |
| - Biocompatibility | Body contact materials evaluated for biocompatibility per FDA Memorandum #G95 1 and ISO 10993-1:2009. |
| - Electrical & Mechanical Safety | Complies with IEC 60601-1:2005/EN 60601-1:2006, IEC 60601-1-11:2010, IEC 60601-2-57:2011. |
| - Electromagnetic Compatibility (EMC) | Complies with FCC part 15. Subpart B, Class B, and IEC 60601-1-2:2007. |
| - Software Safety | Software Validation conducted according to IEC 62304:2006 and FDA Guidance for Software Contained in Medical Devices (May 11, 2005). |
| - Risk Management | Complies with ISO/IEC 14971:2007 (BS EN ISO 14971:2012). |
| - Safety Features (skin proximity/pigmentation) functionality | Device contains a skin proximity sensor and a skin pigmentation sensor. Will not trigger a pulse if not properly applied or if skin tone is too dark/tanned. These features are "the same" as predicate devices. |
| Usability & Effectiveness: | |
| - Intuitive Use / Self-Selection | Usability Study demonstrated that potential end users could self-select appropriately, and 100% of enrolled subjects successfully completed all tasks using the device and instructions in a simulated home environment. |
| - Effectiveness claims supported (hair removal, permanent | "Tests results are supporting all labeling claims in order to establish substantial equivalency." (The specific hair reduction percentages or clinical equivalency data are not provided in this document, but rather a claim that supporting test results exist). Predicate devices provide the basis for these claims. |
| hair reduction) | |
| Technological Equivalence to Predicate Devices: | |
| - Wavelength of light emitted | Same as predicate devices (475 - 1200nm). |
| - Fluence/flux (energy per area) | Same as predicate devices (5 joules/cm² maximum energy). |
| - Pulse duration | Same as predicate devices. |
| - Design and components | Similar to predicate devices (K131870 and K103184). |
Regarding the studies: The document describes one non-clinical "Usability Study" as part of the performance data. It does not describe a clinical study in the traditional sense to prove efficiency for hair removal, but rather relies on substantial equivalence to previously cleared predicate devices for those claims.
2. Sample Size and Data Provenance (for the described Usability Study)
- Sample size: 20 potential device end-users were enrolled in the Usability Study. (3 participants were excluded during self-selection screening).
- Data provenance: Not explicitly stated, but it was a simulated home-use environment, indicating a prospective study specifically for this device. The country of origin for the data is not mentioned, but given the company's location (Israel), it's plausible the study was conducted there.
3. Number of Experts and Qualifications (for the Usability Study)
- No experts were used to establish ground truth for the usability study. The study objective was to test the device's self-selection and usability by potential end-users (lay users), not experts.
4. Adjudication Method (for the Usability Study)
- There was no mention of an adjudication method. The study involved participants completing tasks, and "All of the 20 enrolled subjects (100%) completed all tasks successfully." This suggests direct observation and binary outcome (task completed/not completed) rather than a need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The device is a user-operated hair removal device, not an imaging or diagnostic AI tool that would typically involve multiple human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- The document implies standalone performance of the device's safety mechanisms (skin proximity and pigmentation sensors) as they automatically prevent pulsation if conditions are not met. However, the overall device function requires human operation. The document doesn't detail an "algorithm-only" performance in the context of an AI device, as this is a physical light-based device. If we interpret "standalone" as the device operating as intended without human intervention in its safety features, then yes, those features function standalone.
7. Type of Ground Truth Used (for the Usability Study)
- For the Usability Study, the "ground truth" was the successful completion of predetermined tasks by the lay users. It was based on direct observation of user interaction with the device and instructions, not expert consensus, pathology, or outcomes data in a medical sense.
8. Sample Size for the Training Set
- The document does not describe the development of an AI algorithm with a training set for this device in the common sense. It's a light-based physical device with embedded software and sensors. Therefore, there's no "training set" sample size to report for an AI model.
9. How the Ground Truth for the Training Set Was Established
- As there's no mention of a traditional AI training set, this question is not applicable to the information provided. The "ground truth" for the device's safety features (e.g., what constitutes appropriate skin tone or proper contact) would have been established during engineering design and testing, likely through physical measurements and pre-defined parameters rather than a data-driven training set for an AI model.
§ 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.