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The LUMINA Intense Pulsed Light (& Laser) System is intended for use in applications requiring the selective ablation, vaporization and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialities of general & plastic surgery and dermatology.

The LUMINA Intense Pulsed Light (& Laser) System, when using the IPL Handpieces, is indicated for:

• The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation and ephelides (freckles).
• 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 and to effect stable long-term or permanent hair removal.
• Indicated for use on all skin types (Fitzpatrick I-IV)

The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 1064nm (Long Pulsed and Q-Switched), is indicated for treatment and clearance of:

• Benign vascular lesions such as, but not limited to treatment of:
  • Port wine stains
  • Hemangiomas
  • Superficial and deep telangiectasias (venulectasias)
  • Reticular veins (0.1 - 4.0mm diameter) of the leg
  • Rosacea
  • Venus Lake
  • Leg veins
  • Spider veins
  • Poikiloderma of Civatte
  • Angiomas
• The removal of blue or black tattoos (significant reduction in the intensity of black and/or blue/black tattoos)
• The non-ablative treatment of facial wrinkles, such as, but not limited to:
  • Periocular wrinkles
  • Perioral wrinkles
• The removal of unwanted hair, for stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles.
• Removal or lightening of unwanted hair (with and without adjuvant preparation).
• Pseudofolliculitis barbae (PFB)
• Indicated for use on all skin types (Fitzpatrick I-IV)

The LUMINA Intense Pulsed Light (& Laser) System, when using the internal Nd:YAG Laser Accessory at 532nm (Long Pulsed and Q-Switched), is indicated for:

• Tattoo removal:
  • Light blue
  • Yellow
  • Red
• Benign pigmented lesions such as, but not limited to:
  • Café au lait macules
  • Lentigines (senile and solar)
  • Freckles (ephelides)
  • Chloasma
  • Nevi
  • Nevus spillus
  • Nevus of Ota
  • Becker's nevi

The LUMINA Intense Pulsed Light (& Laser) System is a platform for a range of Intense Pulse Light (IPL) Handpieces and an internal Nd:YAG Laser Accessory for a number of applications in general and plastic surgery and dermatology. The System includes:

• A floor-standing main cabinet unit (including the central control electronics) that controls timing and dosing parameters. This unit also contains a water-cooling system used to remove heat from the IPL Handpieces and the internal Nd:YAG Laser Accessory (if fitted).
• A control and display panel including a touchscreen.
• A range of optional IPL handpieces that include the flashlamp light source, electrical and cooling water connections.

The provided document does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for an AI/ML device. Instead, this is a 510(k) summary for the LUMINA Intense Pulsed Light (& Laser) System, which demonstrates substantial equivalence to a predicate device.

Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to a different type of performance evaluation (e.g., for AI/ML algorithms).

Here's a breakdown of what can be gleaned:

1. A table of acceptance criteria and the reported device performance

This document does not present "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, the "performance" described is the substantial equivalence to a predicate device based on its intended use, indications for use, technological characteristics, and safety testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is not a study involving a test dataset for an AI/ML device. The "test" here refers to safety and electrical performance testing, not clinical data evaluation for performance metrics like sensitivity or specificity.

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)

Not applicable. No ground truth establishment for a test set is described.

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

Not applicable. No adjudication method is described.

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 not an AI/ML device, and no MRMC study is mentioned. This device is a laser/light system for medical treatment.

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

Not applicable. This is not an AI/ML algorithm.

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

Not applicable. No ground truth, in the context of AI/ML performance evaluation, is described. The "truth" in this context is established medical understanding and clinical outcomes from previously cleared, similar devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a training set.

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

Not applicable.

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