InferCare RECIST

InferCare RECIST is post-processing software that displays, processes, analyzes, and measures tumors in multi-timepoint CT images. It is intended for use by trained medical professionals (radiologists, oncologists) to evaluate and manage tumors in various organs and tissues based on RECIST criteria, with AI-assisted lesion segmentation and registration requiring physician confirmation.

The subject device uses artificial intelligence algorithms for automated lesion segmentation and registration, whereas the predicate uses traditional algorithms. Both devices support 2D DICOM viewing, 3D reconstruction, multi-planar reconstruction (MPR), automatic and manual registration, semi-automatic and manual lesion segmentation, and RECIST reporting with measurements of long axis, short axis, volume, and key slice.

IEC 62304:2006+A1:2015 (Medical device software lifecycle processes), ISO 14971:2019 (Risk management for medical devices), FDA Guidance for Device Software Functions (June 2023), and FDA Cybersecurity in Medical Devices guidance (September 2023).

InferCare RECIST is substantially equivalent because it shares the same indications for use, intended users, deployment setting, and core functions (image registration, lesion segmentation, RECIST reporting) as the predicate Multi-Modality Tumor Tracking application. Although the subject device uses AI algorithms while the predicate uses traditional algorithms, performance testing demonstrates the subject device meets predetermined target values for accuracy and safety, and the technological difference does not raise new safety or effectiveness questions.