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The Lumenis Family of Intense Pulsed-Light (IPL) systems and combination 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 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 permanent1, hair reduction in skin types I-VI through selective targeting of melanin in hair follicles;

Nd:YAG Laser Wavelength (1064 nm):

• • 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 non-ablative treatment of facial wrinkles.

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, hyperand/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; and *
• • One or more attached hand-piece(s), which may have integrated skin cooling components.

This is a pre-market notification for a laser system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies (such as MRMC, standalone performance, ground truth, and sample sizes) is largely not applicable in the context of AI/ML device evaluation.

Here's a breakdown of why this information isn't present in the provided text for an AI/ML context:

• Device Type: The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are medical devices that physically interact with tissue for surgical, aesthetic, and cosmetic applications. They are not software-based AI/ML devices that provide diagnostic or prognostic insights.
• Approval Process: The document is a 510(k) submission, indicating a substantial equivalence pathway. This pathway compares the new device to existing legally marketed predicate devices to demonstrate that it is as safe and effective. It does not typically involve the rigorous performance metric evaluations (like sensitivity, specificity, AUC) associated with AI/ML devices.
• "Acceptance Criteria" in this context: For this type of device, "acceptance criteria" primarily refer to demonstrating that the device's technical specifications and performance (e.g., fluence, pulse rate, spot size) are comparable to predicate devices and that clinical data supports its safety and effectiveness for its intended use. There are no "reported device performance" metrics in the sense of AI/ML model output.

However, I can provide the available information relevant to the device's evaluation, reinterpreting "acceptance criteria" and "study" for this non-AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance (Reinterpreted for a Laser System)

Since this is a 510(k) for a laser system, the "acceptance criteria" are implied by its comparison to predicate devices across various technical and functional specifications, and the "reported device performance" is its demonstrated capability to meet those same specifications and achieve the intended clinical effects.

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 and IPL/Nd:YAG laser (1064 nm) systems are safe and effective..."
• No specific sample size, data provenance, or retrospective/prospective nature of the clinical data is provided in this summary. This level of detail is typically found in the full study reports, not necessarily in the high-level 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. For a laser system, "ground truth" isn't established by experts interpreting outputs in the way it is for AI/ML diagnostic tools. The "truth" would be the observed clinical outcome (e.g., hair reduction, lesion clearance, wrinkle reduction) directly from the treatment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI/ML performance evaluation, which is not relevant here.

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

• Not Applicable. This is a laser treatment device, not an AI diagnostic/assistant tool. MRMC studies are for evaluating scenarios where humans are interpreting outputs (e.g., medical images) with or without AI assistance, which is not the function of this device.

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

• Not Applicable. Again, this is a physical laser device, not an algorithm. Its performance is always "standalone" in the sense that it performs its function without an AI element, but it requires a human operator for application.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For a medical treatment device like this laser system, the "ground truth" for demonstrating safety and effectiveness would primarily be clinical outcomes data. This includes:
  • Observed clinical efficacy: e.g., photographic evidence of lesion clearance, hair reduction, wrinkle improvement.
  • Patient feedback: on pain reduction, discomfort.
  • Adverse event reporting: to assess safety.
  • These outcomes would be assessed by clinicians.

8. The sample size for the training set

• Not Applicable. This device does not use a "training set" in the AI/ML sense. Its operational parameters are designed and validated through engineering principles and clinical studies, not by training an algorithm on a dataset.

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

• Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established in this context.

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