(210 days)
The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd: YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:
Intense Pulsed Light Energy/Wavelengths (515 - 1200 nm):
The 515 - 1200 nm intense pulsed light wavelengths are indicated for:
The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars and striae;
The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent , hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Nd:YAG Laser Wavelength (1064 nm):
The 1064 nm wavelength produced by the Nd: YAG laser is indicated for:
The coagulation and hemostasis of vascular lesions and soft tissue, including:
Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg.
Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Real Time Chiller:
The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
Reduce discomfort during and/or associated with light or laser treatment;
Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;
Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).
Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are comprised of the following main components:
A light/laser system console (including software and control electronics);
A control and display panel;
One or two attached handpiece(s);
A skin cooling device integrated into the handpiece (on some handpieces);
A trigger button integrated into the handpiece;
A remote interlock connector (disables light/laser when treatment room door is opened).
The provided text describes a 510(k) submission for the Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems, including the Real Time Chiller. This is a medical device submission, and the information presented here is typical of such submissions, which focus on demonstrating substantial equivalence to previously cleared devices (predicates) rather than establishing new performance criteria through de novo studies.
Therefore, the requested information regarding detailed acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven device's performance metrics (like sensitivity, specificity, F1-score, or human reader improvement, standalone performance) is not directly present in this document. This submission is for a physical laser/light system, and its "performance" is primarily assessed against safety and effectiveness relative to its predicate devices through clinical data (for safety/effectiveness) and engineering specifications (for things like cooling).
However, I can extract the information related to safety and effectiveness demonstration for this type of device, which serves a similar purpose to "acceptance criteria met by study results" in the context of its regulatory clearance.
Here's a breakdown of what can be extracted and inferred from the text, formatted to match your request where possible, and noting where the information is not applicable or not provided for this type of device:
1. A table of acceptance criteria and the reported device performance
For a laser/light system, "acceptance criteria" and "reported device performance" are typically related to clinical safety and effectiveness and adherence to specifications.
| Acceptance Criteria (Inferred from Regulatory Standard) | Reported Device Performance (Summary from Submission) |
|---|---|
| Safety and Effectiveness for Indications | Clinical data demonstrated that the Lumenis Family of IPL/Nd:YAG laser systems (1064 nm) are safe and effective for specific applications in general and plastic surgery, and dermatology. |
| Cooling System Performance | Performance data was provided to demonstrate that the Cooling Head integrated into the Treatment Head operates in accordance with its specifications. |
| Substantial Equivalence to Predicate Devices | The device was found substantially equivalent to predicate devices in terms of indications for use, design features, and similar functional features. |
| Specific Clinical Outcomes (e.g., hair reduction, lesion clearance) | The device effects stable long-term, or permanent, hair reduction in skin types I-V. Indicated for treatment and clearance of superficial and deep telangiectasias and reticular veins (0.1-4.0 mm diameter) of the leg. |
| Epidermal Cooling Efficacy | Real Time Chiller is indicated to reduce pain/discomfort, minimize thermal injury, allow higher fluences, and reduce side effects during light/laser treatment. (Implicitly, the provided data supports these claims). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Clinical data was provided to demonstrate that the Lumenis Family of IPL/Nd: YAG laser systems (1064 nm) are safe and effective..." However, it does not specify the sample size for this clinical data. It also does not specify the data provenance (country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For a physical device, "ground truth" establishment in the context of diagnostic algorithms is not typically a direct component of the regulatory submission in the way you've phrased it. Clinical studies would involve physician assessments of treatment outcomes, but the number and specific qualifications of assessors for "ground truth" are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is not applicable to this device. The Lumenis system is a laser/light treatment device, not an AI-driven diagnostic or assistive imaging tool that involves "human readers" and "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this device. It is a physical treatment device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical data provided, the "ground truth" would be clinical outcomes data related to the indications for use (e.g., observed hair reduction, clearance of vascular or pigmented lesions, safety endpoints like adverse events or reduced thermal injury due to cooling). However, the specific methodology of how this outcomes data was collected and validated is not detailed.
8. The sample size for the training set
This is not applicable as this is not an AI/algorithm-driven device requiring a training set in that sense. Clinical data provided would be for demonstration of safety and effectiveness, similar to a "test set" for performance evaluation, but not for "training" an algorithm.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
Summary for this specific device (Lumenis IPL/Nd:YAG Laser System):
This 510(k) submission focuses on demonstrating substantial equivalence to existing predicate devices based on shared indications for use, design, and functional features. Additionally, clinical data was provided to support the safety and effectiveness of the IPL/Nd:YAG laser systems for their stated specific applications, and performance data was included for the integrated cooling head to show it meets specifications. The document does not provide the granular details often found in submissions for AI/ML-driven diagnostic devices regarding sample sizes, ground truth establishment, or reader studies.
§ 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.