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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 intended 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.

Intense Pulsed Light Energy / Wavelengths (515 - 1200 nm) are indicated for:

• The treatment of tattoos;
• The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides(freckles);
• The treatment of 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, erythema of rosacea, 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.

Nd:YAG Laser Wavelength (1064 nm) 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.
• 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.

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 complications such as scabbing, scarring, hyperand/or possible 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; and
• One or more attached hand-piece(s), which may have integrated skin cooling components.

Here's an analysis of the provided text, outlining the acceptance criteria and the study details based on the information given:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a table format. Instead, it concludes that the device is "safe and effective for their intended and indicated uses" and "substantially equivalent to the predicate devices." The performance claim is equivalency.

2. Sample Size for Test Set and Data Provenance

• Sample Size: The document states that "Clinical data was provided," but it does not specify the sample size (number of patients or cases) used for the clinical evaluation.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It simply refers to "Clinical data."

3. Number of Experts and Qualifications for Ground Truth

The provided text does not mention the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). Since this is a laser and light system for dermatological and surgical applications, clinical outcomes would likely be assessed by treating physicians, but the document provides no details on this.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

• Was an MRMC study done? No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed.
• Effect size of human reader improvement with AI vs. without AI assistance: This is not applicable as an MRMC study was not described, and the device is a laser/light system, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone performance study done? This question is generally relevant for AI/ML algorithms. The device described, the "Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems," is a physical medical device that delivers energy for treatment. Therefore, the concept of a "standalone (algorithm only) without human-in-the-loop performance" study as typically understood for diagnostic AI does not directly apply in this context. The clinical data provided would assess the device's direct therapeutic efficacy and safety.

7. Type of Ground Truth Used

The document implies that the ground truth would be based on clinical outcomes observed in patients treated with the device, such as "selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue," "treatment of tattoos," "treatment of benign pigmented epidermal lesions," "removal of unwanted hair" etc. It is not expert consensus on images, pathology, or solely outcomes data, but rather a direct assessment of the device's therapeutic effects on the patient's condition.

8. Sample Size for the Training Set

This document describes a medical device (laser/light system) rather than a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI development does not apply to this submission. The device is evaluated through clinical trials for safety and effectiveness, not trained on data like an AI model.

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

As explained in point 8, the concept of a "training set" is not applicable to this physical medical device. The "ground truth" for the device's performance would be established through established clinical endpoints and assessments during its clinical evaluation.

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