Search Results

The EmbryoSlide+ ic8 dish is intended for culturing, handling and preparation for transfer of human embryos. The EmbryoSlide+ ic8 dish must be used together with the EmbryoScope+ incubator.

The EmbryoSlide+ ic8 dish is single use, sterile for embryo culture, handling, and preparation for transfer during assisted reproduction technology procedures. The EmbryoSlide+ ic8 dish is equipped with barcode label area for unique identification of the culture dish, and a small area which can be used for manual writing. The EmbryoSlide+ ic8 dish has eight culture wells. Each well holds a single embryo in 20µL of culture medium. In addition, four rinsing wells are available, each rinsing well holding 25-30μL medium. The culture area of the dish, comprising both the culture wells, must be covered with 1.6mL culture oil overlay to minimize osmolarity changes during culture in a dry environment.

I am sorry but this document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. This document is an FDA 510(k) premarket notification for a medical device (EmbryoSlide+ ic8 dish) and primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device.

While it mentions some specifications and testing performed (e.g., sterility, endotoxin testing, mouse embryo assay), it does not detail a formal study designed to prove the device meets specific acceptance criteria in the way you've outlined. The information provided is for regulatory clearance based on substantial equivalence, not a detailed clinical or comparative effectiveness study report.

Therefore, I cannot provide the requested table and detailed study information based on this document.

Ask a specific question about this device