(26 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-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.
| Acceptance Criteria (Implied / Stated Compliance) | Reported Device Performance (with modifications) |
|---|---|
| Safety and Electrical Standards Compliance | Complies with: |
- 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.
§ 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.