Task Progress:
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The goal of this project is to conduct ground-based and International Space Station (ISS) in-flight evaluation of new ultrasound transducer ("ultrasound on a chip") technology coupled with artificial intelligence (AI) solutions to validate their operational usability in astronaut care, including flight, and their innovation potential for operational medical support across all phases of ISS missions. The novel ultra-portable imaging device prototype represents significant innovation for both short- and long-term needs of operational space medicine. The previously unavailable transducer technology allows using one probe for all imaging applications. Importantly, the device is based on the philosophy of continued development, expansion of "smart" features, novice operator-friendly features, and use of cloud-based resources with upgradeability through software and firmware evolution. The device is Digital Imaging and Communications in Medicine (DICOM)-compliant and Food and Drug Administration (FDA)-approved. Thus, the potential benefits identified by this proposal are:
• Concept of operations with near-instantaneous availability of imaging technology, connectivity, and streamlined data handling; • Ultra-portability and small footprint (mass, power, volume) with single-probe solution for all imaging needs; • Deep learning-based tools with automatic target recognition and operator assistance; upgradeability of firmware and software; • Preset-based, intuitive operation supporting non-medical operators, yet offering multiple imaging applications pertinent to space medicine; • Resource savings.
The investigation team is in the process of analyzing data. According to preliminary review of data, this device can serve as an excellent basis for further development and optimization. The approach entirely aligns with the concept of developing autonomous healthcare capabilities in conditions of exploration flight under conditions of multiple constraints, including absent real-time communications with Earth.
In the original proposal the investigation team has proposed to:
1) Select a high-Technology Readiness Level (TRL), DICOM-compliant commercial off-the-shelf (COTS) ultrasound system, with a new single-probe imaging technology, advanced data management with upgradeable deep learning-based solutions, intuitive user interface, and connectivity. The Butterfly iQ (iQ) system (Butterfly Network Inc., N.Y., N.Y.), which has been FDA-cleared and available since 2018, is the only device on the market to meet the above criteria. Most of its features are not available in any single device in the market.
2) Acquire iQ (2 units), other necessary equipment, and supplies for ground-based evaluation (Phase 1).
3) Perform a ground-based evaluation of iQ (Phase 1).
a. Review hardware and electronics, interfaces, and operating functionality through analysis of manufacturer-provided specifications and testing data; b. Test the iQ (all units) using an approved quality assurance phantom, in parallel with a full-featured device for comparison purposes (GE VividQ or similar, i.e., ISS Ultrasound 2), including assessment of: contrast resolution at multiple depths; axial, lateral, and elevational resolution; penetration depth; and others features. c. Perform standardized multi-target imaging tests in human subjects by two trained sonography specialists (Ultrasound subject matter experts/SMEs) in ten (10) human subjects (human-in-the-loop engineering evaluation with appropriate NASA Institutional Review Board/IRB approval). These tests will be duplicated with a full-featured system (similar to the current ISS Ultrasound 2) for comparison. Testing will be used to assess:
• general usability and human factors; • image fidelity and limitations at three different depth ranges; • comparison of iQ with a full-featured system similar or identical to ISS Ultrasound 2.
d. Perform standardized imaging tests and comparison with full-featured portable systems, by point-of-care ultrasound (POCUS) SME physician(s) using POCUS protocols (Focused Assessment with Sonography in Trauma/FAST exam and lung ultrasound protocol) in 5 (five) human subjects (human-in-the-loop engineering evaluation, with appropriate NASA approval), and ultrasound-guided vascular access using a COTS ultrasound-guided vascular access phantom. e. Assess effectiveness of remote guidance, using image streaming if available at the time of this evaluation. Non-Disclosure Agreement (NDA) and additional coordination with the Manufacturer for access to pre-release software may be required. If feasible, this will be performed by using novice operators in a limited scanning test in 5 (five) human subjects (human-in-the-loop engineering evaluation). f. Test effectiveness of AI solutions with novice operators using 10 human subjects (human-in-the-loop engineering evaluation) and observed by Ultrasound SMEs.
4) Develop the analysis framework and perform analysis of imagery, formalized ratings, comments, and observations from all assessments and imaging tests (#3: a-f, above) by ultrasound SMEs with determination of appropriateness of iQ as a prototype for NASA human health and performance capability.
5) Prepare a Ground-Based Evaluation (Phase 1) Report. Presentation of results to TRISH and appropriate NASA organizations/boards.
In addition to the original goals and objectives, the team has initiated and advanced in the preparations for a technology demonstration of the iQ device using ISS as a technology development testbed. This activity is approved through a Supplement to the proposal, which sets a goal to demonstrate functionality and usability of an ultra-portable ultrasound system (Butterfly iQ, Butterfly Network, USA) aboard the ISS in a technology demonstration.
At the time of this interim report, all data collection activities have been completed, and the team has started developing the data analysis framework and outlining the Final Report. Early findings of the investigation, which appear to be favorable, have been shared with the aerospace medicine community through interim reports to TRISH, as well as through presentations at appropriate NASA and public forums.
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