Performance data are often needed to help demonstrate that the proposed device is as safe and effective as the predicate device. These data may include results from engineering, bench, design verification, human factors, animal, or clinical studies. Tests should be conducted in a manner as similar as possible to how the device will be used during routine application. [12]
• The nonclinical data may include simulated use on isolated human skin or animal testing to determine safe dose for human use.
• The amount of clinical data required depends on differences in the labeled indication for use, the use conditions, laser parameters and critical device features between the investigational and the predicate device. Generally a well – controlled, randomized, statistically powered study is required to demonstrate the efficacy and safety of the new device. A pilot test may also be required to validate analytical measures of efficacy and safety, the regimen to be used for the pivotal test and to provide justification for the pivotal study sample size.