(109 days)
The enlighten III laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
1064 nm:
The 1064 nm wavelength of the enlighten III laser system is indicated for:
- treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI)
- tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI)
532 nm:
- The 532 nm wavelength of the enlighten III laser system is indicated for:
- treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-IV
- tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III
670 nm:
- The 670 nm wavelength of the enlighten III laser system is indicated for:
- treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III
- tattoo removal for lighter colored tattoo inks, including green and blue inks, on patients with Fitzpatrick skin types II-IV
The enlighten III laser system is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce multiple laser wavelengths and pulse widths (1064 and 532 nm: 750 ps and 2 ns; 670 nm: 660 ps and 2 ns).
The laser, power supplies, and control electronics are housed inside a console equipped with a touchscreen control panel. The laser treatment parameters are selected using the control panel. Laser emission is activated by depressing a footswitch. An articulated arm with rotational mirror knuckles delivers the laser beam from a laser head inside the console to a handpiece. The handpiece is equipped with an optical zoom assembly that determines the spot size of the laser beam on the treatment surface. The beam of a low-power diode laser is also transmitted through the arm to provide an aiming beam.
The Cutera enlighten III Laser System was studied to assess the safety and efficacy of its 670 nm wavelength for clearing tattoos containing green and/or blue ink.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Efficacy Endpoint) | Reported Device Performance (670 nm wavelength for green/blue ink) |
|---|---|
| ≥ 50% clearing of green and blue inks in ≥ 80% of patients | Greater than 50% clearing was seen in green and blue ink in the tattoos for 84% of subjects. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 27 subjects were initially enrolled. Data analysis was conducted on 25 subjects (2 subjects voluntarily withdrew).
- Data Provenance: The study was an IRB-approved, prospective, two-center clinical study. The country of origin is not explicitly stated in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Three blinded dermatologists.
- Qualifications: "Blinded dermatologists" is the only qualification mentioned. Specific experience levels (e.g., years of experience) are not provided.
4. Adjudication Method for the Test Set
- The text states that "Before and after images of the twenty-five subject tattoos were randomized and sent to three blinded dermatologists for correct identification of the before from after image, and grading of the clearing of the green and/or blue ink."
- It then mentions that "All blinded dermatologists correctly identified the before image for all subjects."
- Regarding grading, the aggregated result is reported (84% of subjects achieved >50% clearing). The specific adjudication method for combining the dermatologists' individual grading scores (e.g., simple majority, average, or if discrepancies were resolved) is not explicitly stated. However, the fact that an overall performance metric is given implies a consensus or combined outcome.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing AI-assisted vs. non-AI-assisted human readers was not conducted. This study focused on the device's standalone performance in a clinical setting.
6. Standalone Performance Study
- Yes, a standalone study was conducted. The clinical trial assessed the safety and efficacy of the enlighten III laser system (the algorithm/device) for tattoo removal when used by medical professionals. This is a direct measure of the device's performance without specific "human-in-the-loop" AI assistance considerations.
7. Type of Ground Truth Used
- Expert Consensus (Blinded Dermatologist Assessment): The ground truth for tattoo clearing was established through the photographic assessment and grading by three blinded dermatologists.
- Investigator Assessment: There was also an investigator assessment of tattoo clearing at six-week post-treatment.
8. Sample Size for the Training Set
- The document does not provide information about a separate training set or its sample size. The clinical study described appears to be a validation/test set for the device's performance.
9. How the Ground Truth for the Training Set Was Established
- As no information about a separate training set is provided, the method for establishing its ground truth is not applicable from this document. The device's performance in the clinical study was evaluated against the ground truth established by the blinded dermatologists and investigators using the actual subjects' tattoos.
§ 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.