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The EsteLux™ Pulsed Light system is intended to for permanent hair reduction. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions.

The CoolRoller™ is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce pain and patient discomfort associated with light applications.

The EsteLux™ is a light-based medical device designed for permanent hair reduction, effective removal of unwanted hair, treatment of facial and leg veins, and treatment of pigmented lesions in all skin types (I-VI). The CoolRoller™ is an accessory providing pre-cooling of the skin, reduction in thermal injury, and reduction in pain and patient discomfort.

The provided text does not contain information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document is a 510(k) summary for a medical device (Palomar EsteLux™ Pulsed Light System and CoolRoller™) which primarily establishes substantial equivalence to a predicate device.

The "Performance Data" section explicitly states: "The differences in the specifications of the EsteLux™ and CoolRoller™, and the predicate devices do not result in different performance or raise new questions of safety or efficacy."

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them based on the provided text. The document indicates that performance data was reviewed, but it does not describe the specific performance metrics, acceptance criteria, or the details of any studies conducted to demonstrate clinical performance.

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