(90 days)
The StarLight™ Pulsed Diode Array Laser System is intended to remove hair in Dermatology and Plastic Surgery procedures.
The StarLight™ 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/cm. The laser pulses are generated at a maximum pulse repetition frequency of 1 Hz by an array of diode. The complete system consists of a console, a footswitch, and a handpiece connected to the console with an umbilical. In standard use, the handpiece is pressed against the patient's skin and a light pulse is delivered when the footswitch and handpiece trigger are depressed. The handpiece tip is water-cooled to provide active skin cooling. Laser parameters and other system features are controlled from the touch-screen on top of the console, which provides an interface to the system computer.
The provided document is a 510(k) summary for the StarLight™ Pulsed Diode Array Laser System, focusing on substantial equivalence to a predicate device. It contains information about clinical studies but does not explicitly state acceptance criteria or provide a detailed breakdown of device performance against such criteria. It also lacks many of the specific details requested regarding the study methodology.
However, I can extract the available information and highlight what is missing based on your request.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety: No scarring or permanent depigmentation of the skin. | "No scarring or permanent depigmentation of the skin in any subject." |
| Efficacy: Significant hair loss and prolonged growth delay. | "resulted in significant hair loss and prolonged growth delay." |
Note: The document does not explicitly state acceptance criteria in a quantitative or pass/fail manner. The reported performance implies that these qualitative outcomes were deemed acceptable for substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided document.
- Data Provenance: The document states "Clinical studies were conducted," implying prospective data collection for the purpose of the submission. The country of origin is not specified, but the applicant and contact information suggest a US-based study if conducted directly by them.
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 "Observations of hair regrowth and skin responses" would likely have been assessed by clinical professionals, but their number and qualifications are not detailed.
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
- No, an MRMC study comparing human readers with and without AI assistance was not done. This device is a laser system for hair removal, not an imaging or diagnostic device that would typically involve "human readers" interpreting results assisted by AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a laser system for hair removal, where the "performance" is the direct physiological effect of the laser on hair and skin, not an algorithm's output.
7. The type of ground truth used
- Clinical observation: The ground truth for efficacy was "Observations of hair regrowth and skin responses" at various time points (1, 3, 6, and 9 months after treatment). For safety, it was the absence of adverse events like scarring or permanent depigmentation. This relies on direct clinical assessment.
8. The sample size for the training set
- This information is not applicable. The device is a physical laser system, not an AI/ML algorithm that requires a "training set." The clinical studies mentioned are for validation of the device's performance, not for training an underlying model.
9. How the ground truth for the training set was established
- This question is not applicable, as there is no "training set" for this type of 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.