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The Spectra VRMII Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

• 532nm Wavelength : Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions Treatment of Lentigines Treatment of Café-Au-Lait Treatment of Seborrheic Keratoses Treatment of Post Inflammatory Hyper-Pigmentation Treatment of Becker's Nevi, Freckles and Nevi Spilus
• 1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos Removal of Nevus of Ota Removal of lightening of unwanted hair with or without adjuvant preparation. Treatment of Common Nevi Skin resurfacing procedures for the treatment of acne scars and wrinkles

The Spectra VRMII Laser System produces a pulsed beam of coherent near infrared (1064 nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromospheres such as melanin and tattoo particles. This increases localized temperature of the chromospheres. The instantaneous temperature increase causes fragmentation of the chromospheres to smaller particles. By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam.

The provided 510(k) summary for the Lutronic Corporation Spectra VRMII Laser System explicitly states: "Performance Data: None presented."

Therefore, based on the provided document, there is no information available regarding acceptance criteria or a study that proves the device meets any specific acceptance criteria. This device was cleared through the 510(k) process based on substantial equivalence to predicate devices, without the need for new clinical performance data to be submitted.

Given this, I cannot fill in the requested table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as no such performance data was presented in this submission.

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