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For incision, excision, ablation, vaporization of soft tissue for general dermatology, as well as at the 1064nm wavelength, dark ink (blue/black) tattoo removal and Nevus of Ota and at the 532nm wavelength, light ink (red) tattoo removal, vascular and pigmented lesions.

Medlite IVTM consists of three main components: the power supply used to provide the proper voltage and current to the laser system, the water cooling system used to remove heat from the power supply and the optical bench consisting of the YAG rod, flashlamp, various mirrors, frequency doubler crystal and articulated arm.

The lasing action of the Medlite IVTM occurs when first the flashlamp is excited by a high voltage electrical pulse from the power supply. The excited flashlamp then emits an intense broad-spectrum light. The YAG rod absorbs most of this light and then releases the energy as laser light at 1064nm.

The Q-Switch acts as an extremely high speed shutter and can be set to release the light at pulse rates of 1, 2, 5, and 10 pulses per second or single shot. The frequency doubler can be enabled to change the 1064nm (infrared) light to a second wavelength at 532nm (green).

This document describes the 510(k) summary for the Medlite IV™ Q-Switched Nd:YAG Laser System. However, it does not contain the specific information required to answer your request regarding acceptance criteria and performance studies.

Here's why and what's missing:

• Type of Device: This is a medical laser system used for dermatological procedures and tattoo removal. It's a physical device, not an AI/software device that would typically have acceptance criteria based on algorithmic performance metrics like accuracy, sensitivity, specificity, etc.
• Study Data: The summary explicitly states:
  • "None presented at this time. Nonclinical Performance Data:"
  • "None presented at this time. Clinical Performance Data:"

Therefore, I cannot provide the requested information. The 510(k) summary for this device focuses on demonstrating substantial equivalence to a predicate device (Polytec PI LaseAway Nd:YAG Laser) by comparing operating parameters, physical characteristics, and intended uses, rather than presenting new performance studies against specific acceptance criteria for AI algorithms.

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