SmartTarget
SmartTarget, Ltd.SmartTarget is a software system designed to assist physicians during image-guided prostate procedures by enhancing visualization. It processes 2D transrectal ultrasound images by performing 3D reconstruction and fusing these images with diagnostic scans like MRI or CT. This helps doctors accurately target and navigate instruments during biopsies, ablations, and other treatments, improving procedure precision and patient outcomes.
Intended Use
Accessory for image-guided interventional and diagnostic procedures involving the prostate gland to enhance visualization of 2D transrectal ultrasound images, enabling segmentation, 3D reconstruction, image review, annotation, and instrument tracking in clinical settings.
Technology
Software that performs 3D reconstruction of TRUS video images, fuses these with pre-acquired 3D images such as MRI or CT, supports segmentation, multiplanar views, image annotation, and records instrument locations. It interfaces with a third-party mechanical stepper device with digital position encoders for TRUS probe tracking, using Windows OS.
Performance
Non-clinical performance testing was conducted including verification and validation of input/output functions. Using synthetic prostate phantoms, image registration accuracy showed a mean alignment error of 2.0 mm and needle placement error of 2.9 mm, deemed acceptable for clinical use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/27/2017
4 months - 2
FDA Approval
6/7/2017
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