Validation of Vue Tek Digital Vein Viewing Device
Validation of Vue Tek Digital Vein Viewing Device
VueTek has developed a head mounted device that will improve the viewing of superficial, subcutaneous vasculature, differentiating it with higher contrast from surrounding tissue. Video of the vasculature is displayed to the user in a portable headset. The headset and display combination facilitates both visualization in the display and an open field of view directly to the subject's anatomy and practitioner's surroundings. The goal is to provide a non-diagnostic, enhanced visual aide that is used alongside standard visual and tactile methodology. The primary and secondary objectives of this validation are as follows:
Primary Objective:
To demonstrate that the VTS1000 affords visualization of superficial, subcutaneous vascular structures, when compared to the naked eye.
Secondary Objective:
To demonstrate that the VTS1000 enhances visualization of superficial, subcutaneous vascular structures over the naked eye.
Validation Ancillary Endpoints
1. To gather data to demonstrate that the VTS1000 is portable, affords conventional vascular access methods, and provides flexibility, fit and balance during use.
Validation methodology:
Ten (10) or more independent qualified practitioners trained to operate the device in accordance with the Directions For Use (DFU), and after completing the Device Usability aspect of the study, will be asked to perform simulated procedures with and without the device as indicated in the DFU on one-hundred (100) or more subjects using the following subject population and sampling table. A minimum of one hundred (100) or more data collection observations will be recorded, tabulated and reported.
Assumptions: The population and sampling sizes chosen for each subject category will meet the goal to attain sufficient diversity to satisfy representation that supports the efficacy of the device across the population samples. Any failures or results from the acceptance criteria may require an increase in the sampling size to ensure coverage representation of all subject demographics.