CLEARREAD +CONFIRM

ClearRead +Confirm is a post-processing software application designed to facilitate the confirmation of line and tube placement in adult chest radiographs by generating an enhanced secondary image. It employs a bone suppression algorithm, with specific enhancements to improve line and tube visibility, thereby aiding trained professionals in localizing these devices more efficiently.

ClearRead +Confirm is a specialized post-processing software application designed to create an enhanced, secondary digital radiographic image of the chest. Its purpose is to assist trained medical professionals, such as physicians, radiologists, and technicians, in confirming the placement of lines and tubes in adult patients. The system employs a bone suppression algorithm, building upon the technology of a predicate device, ClearRead Bone Suppression, but with specific enhancements aimed at improving the visibility of these medical apparatuses. The enhanced AP or PA image produced serves as an adjunctive tool and is not intended to replace the original radiograph, nor is it intended for use on pediatric patients. The performance of ClearRead +Confirm was assessed through functional verification and a clinical validation study involving multiple readers and cases (MRMC). This clinical study focused on evaluating whether the software reduced the time radiologists spent localizing the tips of tubes, lines, and electrical cardiac wires (TLW), and also assessed localization accuracy compared to unaided image review. The findings demonstrated that ClearRead +Confirm significantly decreased the reading time required for TLW localization. While the accuracy of localization with the software was not found to be statistically significantly different from unaided reads, the overall results suggest it is a beneficial adjunct for interpreting chest radiographs when assessing TLW placement. The system shares a common DICOM communication platform with its bone suppression predicate and offers similar line/tube enhancement capabilities to another predicate device.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What is the specific nature of the "enhancements to improve the visibility of lines and tubes" beyond the foundational bone suppression, and how were these optimized during development?; The MRMC study showed significantly decreased read times; what was the mean reduction in time per reading, and was this reduction consistent across different types of lines/tubes or reader experience levels?; Given that localization accuracy was not statistically significantly different, what metrics or qualitative feedback, if any, indicated that ClearRead +Confirm is a "useful adjunct" beyond just speed?; How robust is the ClearRead +Confirm algorithm to variations in image quality or patient anatomical variations (e.g., obesity, severe lung pathology) that might affect chest radiograph interpretation?; What specific training protocol is recommended for professionals to effectively utilize ClearRead +Confirm, and how does the system guide users in distinguishing enhanced features from potential artifacts?