Fluorescence Guided Surgery Standardization Tools

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Abstract Optical imaging systems form the largest technological market sector in medicine today, dominating tool development in many surgical and gastroenterology specialties. Yet when advanced optical imaging devices are compared to radiological devices, there is a stark lack of calibration, validation and standardization which occurs. The lack of methods for multicenter calibration, standardization between vendors, and regulatory guidance on performance targets across vendors, all leads to a high inefficiency and lack of reproducibility, and a lack of the ability to switch imaging systems for the same use, as is done routinely in radiology. One of the more complicated but critical factors with optical imaging in tissue is accounting for how tissue optical properties, spectral range and tissue layers/depths affect the image quality in non-linear and non-intuitive ways. In this application, we develop an implicitly scalable venture, 3D printed surgical device test targets, coupled to a consulting network for performance evaluation, validation, system comparison, multi-center trial coordination, and inter-platform comparisons for inter-changeability and FDA clearance. To support the effort, we develop cloud based software data storage for test results, training protocols for users and network a group of expert users from academics, three surgical specialties and industry, to iteratively improve the value proposition. The focus of aim 1 in this application will be on complete automation of production of the test targets via 3D printing, to allow the simplest supply chain of production with each order. Aim 2 follows by hardening up our performance assessment goals as measured by the targets, iteratively developing recommendations for the individual systems with our expert consultants in each of general surgery, head and neck surgery and neurosurgery. The proposal follows years of study of the issue by a professional task group and identification of the key aims, including (i) automation of production, ii) distribution of at least 2 designs across at least 6 centers, and (iii) training and professional guidance for the field. The outcome of this work is directly targeted for fluorescence guided surgery as it is an emerging paradigm. The growth in new companies who differentiate themselves by unique system capabilities makes for a market where new 510(k) cleared devices may have the same indication, yet have differences in spectral ranges, magnifications, real-time display capabilities, and so the need for standardization is even more essential today. Objective performance evaluation will help homogenize performance and use and provide guidance to academics, surgery and industry. Beyond this field though, the extension of these targets to more traditional optical imaging tools used in medicine will also naturally occur as will our custom consulting and production, as we establish this platform and industry and academic networks.