Study for method and standard of performance evaluation on vitrectomy system

Abstract

Vitrectomy system is medical electronic surgical device used during ophthalmic surgery to vitreous body and to remove crystalline lens and other substances by aspirating and cleansing, and it is used in diabetic retinopathy and vitrectomy. Demand of vitrectomy system based on the increase in number of diabetic retinopathy patients in the United States and other major countries is increasing, but standard for the performance evaluation on vitrectomy system is not prepared clearly. Therefore, this study researched on approval and current market situations to establish the standard for performance evaluation on vitrectomy system, and researched and analyzed related domestic and international standard and guidance to draw the testing areas, standard and method of performance evaluation on vitrectomy system accommodated internationally. Through the result of this study, it is expected to improve the quality and safety of product by providing convenience to the related medical device industry.