AccuContour 4.0

AccuContour 4.0 is a standalone software system used by radiation oncology departments to automatically segment CT images and register multi-modality images. It generates information needed for treatment planning, treatment evaluation, and treatment adaptation. The device includes two variants: AccuContour (full-featured) and AccuContour-Lite (lightweight version with reduced functionality).

AccuContour 4.0 adds three major features compared to the predicate: an AccuContour-Lite lightweight variant, AI-based Synthetic CT auto-contouring for 46 organs and structures, and registration support for 4DCT imaging. Both versions use deep learning algorithms with GPU/CPU support for contouring, support DICOM 3.0 compliance, and run on Windows operating systems. The full AccuContour variant adds fusion registration, plan comparison, and dose display capabilities not present in the predicate.

Not stated in this summary. The document references FDA guidance documents on software verification and validation but does not cite specific ISO, IEC, or ASTM consensus standards.

AccuContour 4.0 is substantially equivalent to the predicate device AccuContour (K221706) because it maintains the same indications for use, regulatory classification (Class II), product code, and core functionality for CT image segmentation and registration. Performance testing demonstrated that synthetic CT contouring achieves clinically acceptable accuracy (DSC and HD95 metrics meeting pass criteria) across 46 anatomical structures, and 4DCT registration functions meet established performance requirements with only minor edits needed for clinical use.