(231 days)
The enlighten laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
532 nm
The 532 nm wavelength of the enlighten laser system is indicated for the treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III.
1064 nm
The 1064 nm wavelength of the enlighten laser system is indicated for the treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI).
The enlighten laser system is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm) and pulse widths (750 ps and 2 ns, nominal). 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. The system is operated using 110 V mains AC power. 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 a detachable tip that determines the spot size of the laser beam on the treatment surface. Multiple tips are provided to vary the spot size as desired for treatment. The beam of a low-power red diode laser is also transmitted through the arm to provide an aiming beam.
The provided document describes the enlighten Laser System and its clearance for marketing. While it details the clinical studies performed to establish safety and efficacy, it does not explicitly state quantitative acceptance criteria (e.g., "The device must achieve X% sensitivity and Y% specificity"). Instead, acceptance appears to be based on demonstrating "clinically and statistically significant improvement" and "safety and effectiveness" comparable to predicate devices.
Here's an attempt to extract and infer the requested information based on the available text:
Acceptance Criteria and Device Performance Study for the enlighten Laser System
The enlightenment Laser System's acceptance criteria, while not explicitly defined as pass/fail thresholds in the provided document, appear to center around demonstrating clinically and statistically significant improvement in benign pigmented lesions, good patient satisfaction, and an acceptable safety profile. The study supporting these claims are two IRB-approved prospective clinical studies.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Study Goals) | Reported Device Performance (as stated in the document) |
|---|---|
| 532 nm Wavelength for Fitzpatrick Skin Types I-III: | 532 nm Wavelength: |
| - Demonstrate clinically and statistically significant improvement (clearing) of benign pigmented lesions. | - Clinically and statistically significant median improvement of 1.50 (on a scale not explicitly defined, but implying a positive change. One-sample Wilcoxon signed rank test, 95% CI: 1.25 - 2.00, P=0.000). |
| - Achieve high consistency and accuracy in blinded photographic identification of before/after photos. | - Reviewers were highly consistent and accurate (kappa of 1, P=0.000) in identification of the before and after photographs (all 20 randomized photos correctly identified by both reviewers). |
| - High patient satisfaction with lesion clearing. | - 95% of subjects reported "satisfied" and "very satisfied" with the improvement. |
| - Acceptable pain levels during treatment. | - All subjects tolerated treatments well (median pain score of 1.4 out of 10). |
| - Acceptable safety profile with resolution of adverse events and no serious adverse events, questionable, precancerous, or malignant lesions. | - Adverse effects resolved without intervention. No serious adverse events noted. No questionable, precancerous or malignant lesions observed during the 24-week follow-up. |
| 1064 nm Wavelength for Fitzpatrick Skin Types I-VI: | 1064 nm Wavelength: |
| - Demonstrate clinically and statistically significant improvement (clearing) of benign pigmented lesions. | - Clinically and statistically significant median improvement score of 0.75 (one-sample Wilcoxon signed rank test, 95% CI: 0.25 - 1.0, p=0.001). Mean improvement score was 0.6. |
| - High patient satisfaction with lesion clearance. | - 91% of subjects expressed satisfaction with lesion clearance. |
| - Acceptable pain levels during treatment. | - All subjects tolerated treatments well (mean pain score of 2.5 ± 1.3 out of 5 - scale implied by range). |
| - Acceptable safety profile with resolution of adverse events and no serious adverse events, questionable, precancerous, or malignant lesions. | - All adverse effects resolved without intervention. No serious adverse events noted. No questionable, precancerous or malignant lesions observed during the 12-week follow-up period. |
| - Histological agreement with published studies (for both wavelengths). | - The treatment outcomes and histology observed in this study for 532-nm and 1064-nm treatment agree with the results of published studies with nanosecond QS lasers, which had the same mechanism of action and tissue interaction as the study device and have a proven baseline efficacy. (Implicitly, the biopsies showed expected tissue changes post-treatment consistent with efficacy and safety). |
| - Substantial equivalence to predicate devices for requested indications (overall criterion for 510(k) clearance). | - Treatment of benign epidermal pigmented lesions with the enlighten laser system was found to be safe and effective, with minimal discomfort and adverse effects, allowing the conclusion that the enlighten laser system is substantially equivalent to the predicate devices for the requested indications. |
- The enlighten laser system is comparable to the predicate devices in terms of indications for use, technical specifications, operating performance features and general design. |
2. Sample Size Used for the Test Set and Data Provenance
- 532 nm Wavelength Test Set:
- Sample Size: 20 subjects.
- Data Provenance: Prospective clinical study within the US (implied by IRB-approved, no specific country mentioned, but typical for FDA submissions).
- 1064 nm Wavelength Test Set:
- Sample Size: 23 subjects.
- Data Provenance: Prospective clinical study within the US (implied by IRB-approved).
- Histology Test Set:
- Sample Size: Biopsy samples from 2 subjects (volunteer basis).
- Data Provenance: Prospective clinical study within the US (implied by IRB-approved).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: 2 independent dermatologists.
- Qualifications of Experts: The document states "two independent dermatologists" but does not explicitly mention their years of experience or specific board certifications.
4. Adjudication Method for the Test Set
The document describes "Blinded assessment of improvement (clearing) in pigmented lesions was completed by two independent dermatologists."
For the 532 nm study, it states: "The reviewers were highly consistent and accurate (kappa of 1, P=0.000) in identification of the before and after photographs (all 20 randomized before and after photos were correctly identified by both reviewers)."
This suggests that both dermatologists independently reviewed the images. The high kappa value indicates strong agreement, implying that there was likely no formal adjudication needed in this case as they agreed on all assessments. If there had been disagreements, the document does not specify a tie-breaking or adjudication rule (e.g., 2+1 majority voting).
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 comparative effectiveness study involving human readers with and without AI assistance was not done.
This device is a laser system for direct treatment, not an AI-based diagnostic or assistive software. The evaluations were on the outcome of the laser treatment on patients, assessed by human experts blinded to the treatment order/timing, not on how human readers perform diagnostic tasks with or without AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in spirit, the primary evaluation of the device itself is standalone. The clinical studies evaluate the direct effect of the enlighten Laser System on human subjects. The device's "performance" is measured by its safety and efficacy in treating benign pigmented lesions, independent of real-time human interpretation assistance for diagnosis. The human experts (dermatologists) in the study were used to assess the outcome of the device's standalone action, not to operate an algorithm or make real-time decisions based on an AI output.
7. The Type of Ground Truth Used
- Primary Ground Truth: Expert consensus of two independent dermatologists based on blinded photographic assessments of lesion improvement (clearing).
- Secondary Ground Truth: Patient questionnaires regarding satisfaction, pain levels, and observed adverse events.
- Tertiary Ground Truth: Histology results from biopsy samples (for 2 subjects) to confirm tissue changes post-treatment.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device (laser system), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The clinical studies described are for validation of the device's safety and efficacy.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is a laser system, not an AI/ML algorithm.
§ 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.