True Definition DL

True Definition DL is a deep learning-based CT image reconstruction software that enhances spatial resolution for bone and lung imaging. It is an optional reconstruction algorithm available on Revolution CT and Apex family CT systems that can be selected by users in three different strength levels, intended for patients of all ages.

True Definition DL uses a 1024 x 1024 reconstruction matrix compared to the predicate's 512 x 512 or 1024 x 1024 options. The proposed device is narrower in anatomical scope, focusing exclusively on bone and lung imaging, whereas the predicate covers head, body (including bone and lung), and cardiac applications. Both use the same hardware platform (operator console for Revolution systems) and clinical workflow with selectable strength levels.

Not stated in this summary. The document references industry-standard IQ (image quality) metrics and mentions ISO 13485 design controls and ISO 13484 nonconforming product requirements as part of the Quality Management System, but does not cite specific consensus standards like ISO, IEC, or ASTM for testing.

True Definition DL is substantially equivalent because design verification and validation testing, including bench testing on phantoms and a clinical reader study, demonstrated equivalent image quality and performance to the predicate device without raising new safety or effectiveness questions. The algorithm improves in-plane and cross-plane resolution without significantly increasing image noise, and clinical evaluation confirmed no algorithm-induced artifacts while providing diagnostic value for high-contrast structures in bone and lung imaging.