(230 days)
The LightSheer™ is intended to effect temporary hair reduction. The LightSheer™ is also intended to effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime.
The LightSheer™ delivers pulsed infrared laser light with a wavelength of 800 nm, a selectable pulse duration of 5 - 30 ms, and a selectable pulse energy of 8 - 32 J. The corresponding fluence delivered through the 9 x 9 mm handpiece tip is 10 - 40 J/cm2. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode lasers located in the handpiece. The handpiece tip is water-cooled to provide active skin cooling.
The provided text describes the LightSheer™ Pulsed Diode Array Laser, which is intended for hair reduction. Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated Intended Use) | Reported Device Performance (Results of Clinical Study) |
|---|---|
| Effect temporary hair reduction. | The study demonstrated that LightSheer™ is a safe and effective tool for permanent hair reduction. (Implying temporary reduction would also be achieved) |
| Effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. | The study demonstrated that LightSheer™ is a safe and effective tool for permanent hair reduction. "Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime." |
| No scarring or permanent skin injury. | There was no scarring or permanent skin injury in any subject. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact number of subjects or hair sites included in the clinical study. It only refers to "any subject."
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, given that it's a 510(k) submission for a new device claiming effectiveness for its intended use, it would typically be a prospective clinical trial conducted in the country of the applicant (USA, based on the address).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The clinical study describes "Observations of hair and skin responses were recorded," but it does not specify who made these observations or their qualifications.
4. Adjudication method for the test set
This information is 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
An MRMC study was not done. This device is a laser for hair reduction, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The LightSheer™ is a physical medical device (laser system), not a software algorithm. Its performance is inherent in its operation, not in an algorithm that could be run standalone.
7. The type of ground truth used
The ground truth appears to be direct observation of hair regrowth and skin responses by unspecified personnel. The definition of "permanent hair reduction" also serves as a ground truth criterion. There is no mention of pathology or other objective outcome data, beyond visual assessment of hair and skin.
8. The sample size for the training set
This information is not applicable/provided. As a physical device, there is no "training set" in the context of machine learning. The device's parameters (wavelength, pulse duration, energy, fluence, etc.) are designed based on scientific principles and prior research into laser-tissue interaction for hair removal, rather than on a data-driven training process.
9. How the ground truth for the training set was established
This information is not applicable/provided. As explained above, there is no "training set" for a physical laser device in the way there is for an AI algorithm. The scientific basis for its design would come from general knowledge of light absorption by melanin and tissue thermal damage, which is established through extensive scientific literature and research, not a specific "training set" with ground truth in the context of the regulatory submission.
§ 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.