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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)
• treatment of acne scars on patients with Fitzpatrick skin types II-V when used with the Micro Lens Array handpiece attachment

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, as well as an optional Micro Lens Array handpiece attachment, which can be attached to the distal end of the handpiece to fractionate the treatment beam. The beam of a low-power blue diode laser is also transmitted through the arm to provide an aiming beam.

This document describes the Cutera enlighten III Laser System and its expanded indications for use, specifically for the treatment of acne scars with the Micro Lens Array handpiece attachment.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 33 subjects
• Data Provenance: The study was a prospective, multicenter, pivotal study. The country of origin of the data is not explicitly stated, but as the submission is to the U.S. FDA, it is generally assumed to be from the U.S. or international sites adhering to similar regulatory standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Three blinded dermatologist evaluators.
• Qualifications of Experts: They were identified as "dermatologist evaluators," implying they are medical doctors specializing in dermatology. No specific details on their years of experience are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: "at least two of three blinded dermatologist evaluators." This indicates a 2/3 consensus or majority rule for assessing improvement.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• A MRMC comparative effectiveness study was not directly reported in terms of comparing human readers with and without AI assistance. The study described is a clinical trial assessing the device's efficacy and safety for treating acne scars; it is not focused on an AI component for diagnosis or evaluation by human readers.

6. Standalone (Algorithm Only) Performance Study

• A standalone algorithm-only performance study was not applicable/not performed as this device is a laser system for treatment, not an AI diagnostic or assistive algorithm.

7. Type of Ground Truth Used

• The ground truth for the efficacy endpoint (improvement in acne scars) was established by expert consensus (at least two of three blinded dermatologist evaluators) based on the visual assessment of randomized baseline and follow-up images.
• Patient satisfaction and willingness to undergo treatment again serve as a form of patient-reported outcomes data.

8. Sample Size for the Training Set

• The document describes a clinical study for the validation of the device's efficacy and safety for a new indication. It does not mention a "training set" in the context of an algorithm. The 33 subjects are part of the evaluative study, not a training set for an AI model.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no mention of a "training set" for an algorithm in this submission. The 33 subjects were part of the prospective clinical study to assess the device's performance for the expanded indication.

Ask a specific question about this device

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

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.

Ask a specific question about this device

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-III
• 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 pigments with Fitzpatrick skin types I-III.

The modified Cutera 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.

This document is an FDA 510(k) premarket notification for a modification to the Cutera enlighten III Laser System. It focuses on demonstrating substantial equivalence to a previously cleared device. Therefore, it does not contain the kind of detailed study data (like sample sizes, expert qualifications, or comparative effectiveness with human readers) that would be present in a clinical trial report for a new device.

Here's an analysis of what is and isn't provided based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it details modifications to the device's operational parameters and then asserts that these modifications do not introduce new risks or change the intended use, implying that the device, with these modifications, still meets the safety and effectiveness profile of its predicate.

However, the key performance data discussed relates to the device's technical specifications and compliance with safety standards.

• IEC 60601-1 (Edition 3.1, 2012)
• IEC 60601-1-6 (Edition 3.1, 2013)
• IEC 62366 (Edition 1.1, 2014)
• IEC 60601-2-22 (Edition 3.1, 2012)
• IEC 60825-1 (Edition 2.0, 2007)
• AAMI/ANSI ES60601-1:2005+A2 (R2012)+A1
• IEC 60601-1-2 (Edition 3, 2007) |
  | Maximum Delivered Energy | 1064 nm: Increased from 600 mJ to 800 mJ (maintaining 10 J/cm² max fluence)
  532 nm: Increased from 300 mJ to 400 mJ (maintaining 2.5 J/cm² max fluence) |
  | Maximum Treatment Fluence | 1064 nm: Maintained at 10 J/cm²
  532 nm: Maintained at 2.5 J/cm² |
  | Spot Sizes | Added 9 mm and 10 mm incremental spot sizes for 1064 nm and 532 nm wavelengths. |
  | Pulse Duration | Added 2 ns pulse duration for the 670 nm wavelength. |
  | No New Risks Introduced | Affirmed based on unchanged maximum treatment fluence and no changes to intended use or indications for use. |
  | Equivalence in Intended Use/Indications | Identical to predicate device. |
  | Equivalence in Technical Specifications | Similar or within range of predicate and reference devices in spot sizes, wavelengths, pulse widths, laser types, and repetition rates. |
  | Equivalence in Operating Performance | Similar to predicate and reference devices. |
  | Equivalence in General Design | Similar to predicate and reference devices. |

2. Sample size used for the test set and data provenance

The document refers to a "Performance Data: enlighten III Software Verification and Validation Testing Report (V0140 rA1)". This report likely contains the details of the test set and data provenance for the software modifications. However, the FDA letter does not provide any specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for clinical or performance data related to the device's efficacy in treating patients.

The "testing" mentioned primarily concerns software verification and validation and compliance with electrical and safety standards, not a clinical study on human subjects with a "test set" in the context of diagnostic accuracy.

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. As this is a 510(k) for a laser system modification, the "ground truth" would likely refer to the physical output parameters of the laser, verified by engineering and metrology, rather than expert clinical consensus on patient outcomes, which is typical for AI diagnostic devices.

4. Adjudication method for the test set

This information is not provided. Given the nature of the device (a laser system for treatment), "adjudication method" in the context of reconciling expert opinions (as described by "2+1, 3+1") is not relevant here. The "testing" pertains to engineering standards and device performance specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done or described in this document. This type of study is relevant for evaluating the impact of AI algorithms on human reader performance, typically in diagnostic imaging, which is not the function of this laser system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This concept is not applicable to this device. The Cutera enlighten III is a physical laser system, not a diagnostic algorithm. The "algorithm" here refers to the control software that dictates the laser's operational parameters, and its "performance" is judged by its ability to control the hardware within specified tolerances and safety limits.

7. The type of ground truth used

The implicit "ground truth" for this device's performance is its technical specifications and adherence to international safety and electrical standards (e.g., IEC 60601-1, IEC 60825-1, etc.), as well as the accurate output of laser parameters (energy, fluence, spot size, pulse duration). This is established through engineering measurements and metrology, not pathology, outcomes data, or expert clinical consensus on patient diagnosis.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device's "software modification" does not involve machine learning or AI models that require a "training set" in the typical sense of classifying data or predicting outcomes. The software is a set of control logic and algorithms to operate the laser system.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as #8.

Ask a specific question about this device

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-III
• 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 pigments with Fitzpatrick skin types I-III.

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).

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.

Here's an analysis of the acceptance criteria and study proving the device's performance, based on the provided text:

Device: enlighten III Laser System
Indications for Use (670 nm wavelength): Treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with pre-defined numerical targets. Instead, the study aims to demonstrate safety and efficacy, implicitly establishing that a certain level of improvement and safety is acceptable for market clearance. Based on the study results, the implied acceptance criteria for efficacy appears to be achieving statistically significant lightening (>50% improvement) and high patient satisfaction for the treatment of benign pigmented lesions. Safety is assessed by the absence of serious adverse events and good tolerability.

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