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510(k) Data Aggregation
(227 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.
1064 nm: The 1064 nm wavelength of the enlighten laser system is indicated for 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 laser system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
The enlighten laser system is a multi-wavelength, pulsed laser system designed for tattoo removal. 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.
Acceptance Criteria and Device Performance Study for the Enlighten Laser System
This document outlines the acceptance criteria and a detailed description of the study conducted to demonstrate the performance of the enlighten Laser System for tattoo removal.
1. Acceptance Criteria and Reported Device Performance
The core acceptance criteria for the enlighten Laser System, as demonstrated by the clinical study, revolves around the efficacy of tattoo clearing and safety.
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implicit from Study Design) | Reported Device Performance |
|---|---|---|---|
| Efficacy (Overall) | Mean improvement in tattoo clearing (Blinded Reviewer Global Assessment) | Statistically significant and clinically meaningful improvement in tattoo clearing compared to baseline, and demonstration of substantial equivalence or superiority to a comparator device. | Overall Mean Improvement: 2.54 (95% CI: 2.13–2.94) for the investigational device vs. 2.17 (95% CI: 1.77–2.57) for the comparator device at 6 weeks post-final treatment. Mean Difference: 0.37 (95% CI: 0.20–0.53) indicating statistically significant (p<0.001) greater clearing for the investigational device. |
| Efficacy (Pulse Duration) | Mean improvement with ps pulse durations only | Clinically and statistically significant mean improvement. | Mean Improvement: 3.2 (95% CI: 2.54 – 3.86, p<0.001) for ps pulses only. Difference vs. Comparator: 0.7 (95% CI: 0.22 - 1.18, p=0.01) – greatest difference. |
| Mean improvement with combined ps and ns pulse durations | Clinically and statistically significant mean improvement. | Mean Improvement: 2.77 (95% CI: 2.23 - 3.32, p<0.001) for combined ps and ns pulses. Difference vs. Comparator: 0.46 (95% CI: 0.10 – 0.81, p=0.015). | |
| Mean improvement with ns pulse durations only | Clinically and statistically significant mean improvement. | Mean Improvement: 2.3 (95% CI: 1.91 - 2.69, p<0.001) for ns pulses only. Difference vs. Comparator: 0.26 (95% CI: 0.05 - 0.47, p=0.018). | |
| Efficacy (Wavelength) | Mean improvement with 532 nm wavelength | Clinically and statistically significant mean improvement, consistent with overall study population. | Mean Improvement: 2.6 (95% CI: 1.91 - 3.29, p<0.001) for 532 nm wavelength. Consistent with overall study population. |
| Mean improvement with 1064 nm wavelength | Clinically and statistically significant mean improvement, consistent with overall study population. | Mean Improvement: 2.53 (95% CI: 2.21 - 2.85, p<0.001) for 1064 nm wavelength. Consistent with overall study population. | |
| Efficacy (Skin Type) | Mean improvement for Fitzpatrick Skin Type I-III | Clinically and statistically significant mean improvement, consistent with overall study population. | Mean Improvement: Consistent with total study population in both investigational and comparator arms. (Specific numerical value for I-III not explicitly stated, but stated as "consistent"). |
| Mean improvement for Fitzpatrick Skin Type IV-VI | Clinically and statistically significant mean improvement. | Mean Improvement: 2.33 (95% CI: 1.55 – 3.12, p<0.001) for FST IV-VI. Slightly lower than overall study mean, but comparator arm also lower by a similar margin. | |
| Safety | Incidence and severity of adverse events | Tolerable treatments, equivalent adverse event profiles to comparator device, and no serious adverse events. | Pain Scores: Similar with both devices (mean 4.1 vs. 4.4 on 0-9 scale). Common AEs: Expected erythema, edema, and pin-point bleeding in both arms. Serious AEs: No serious adverse events reported. Subgroup AEs: Equivalent adverse event profiles for all subgroups; no significant differences in incidence/severity. |
| Additional Data | Mean tattoo clearance for unilateral picosecond-only treatments (12 weeks post-final) | Consistent with 6-week picosecond-only data from the main study. | Mean Clearance: 3.4 for 19 additional unilateral picosecond-only treatments at 12 weeks post-final treatment, consistent with the 3.2 clearance rating from the 6-week data. AEs: edema and erythema consistent with main study; no unexpected or serious adverse events. |
| Substantial Equivalence | Overall comparison to predicate devices | Demonstrate substantial equivalence to predicate devices in terms of indications for use, technical specifications, operating performance features, and general design, with equivalent or superior safety and effectiveness. | The study concluded that the enlighten laser system is substantially equivalent to the predicate devices for the requested indication based on safe and effective tattoo removal, with the investigational device showing statistically significant (p<0.001) greater clearing than the comparator. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Forty-two (42) subject tattoos were initially enrolled, with forty-one (41) completing the study (1 lost to follow-up).
- Data Provenance: The study was a multicenter prospective clinical study. The country of origin is not explicitly stated in the provided text, but the FDA submission context suggests it was likely conducted in the US or in a manner compliant with US regulatory standards.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: A panel of independent, blinded reviewers (plural, implying more than one) was used. The exact number is not specified, but typically, panels consist of 3 or more experts.
- Qualifications of Experts: The experts were identified as "dermatologists." Further details on their years of experience or board certification are not provided in this summary.
4. Adjudication Method for the Test Set
The adjudication method is not explicitly stated as a formal consensus or voting model (e.g., 2+1, 3+1). However, "Blinded review of baseline and post-treatment tattoo photographs resulted in a clinically and statistically significant mean improvement of..." suggests that the individual assessments of the blinded reviewers were aggregated and analyzed statistically (e.g., averaged) to produce the reported improvement scores rather than a strict adjudication for each case to reach a single consensus ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Yes, a comparative effectiveness study was performed. The study compared the "enlighten Laser System" (investigational device) against a "comparator Q-Switched Nd:YAG laser."
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: This metric is not applicable as the study was not evaluating an AI system or human-in-the-loop performance. It was a direct comparison of two laser devices, not an AI-assisted diagnostic or treatment planning tool. The "readers" here were medical dermatologists assessing photographic evidence of treatment outcome.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. The enlighten Laser System is a physical medical device (laser system) and its performance was assessed through a clinical study involving human patients and laser treatments administered by healthcare professionals, with outcomes assessed by human expert reviewers.
7. Type of Ground Truth Used
The ground truth for assessing efficacy was established through expert consensus (or aggregated expert assessment) of photographic evidence. Blinded dermatologists reviewed standardized photographs taken at baseline and 6 weeks post-final treatment to assess "tattoo clearing."
Safety ground truth was established by investigator assessments at each visit and through subject-reported phone surveys for adverse events.
8. Sample Size for the Training Set
The provided document describes a clinical study to assess the safety and efficacy of the enlighten Laser System. It does not mention any "training set" in the context of an algorithm or machine learning model. The study described is a clinical trial to evaluate the device itself.
9. How Ground Truth for the Training Set was Established
As there is no mention of an algorithm or machine learning component, there is no "training set" or ground truth establishment method for it described in this document. The clinical study served to validate the performance of the physical laser device.
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(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.
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