Clarify DL is a software solution that uses deep learning integrated with iterative image reconstruction techniques to reduce noise and improve image quality in Nuclear Medicine bone SPECT images. It helps clinicians by enhancing image clarity which potentially improves diagnostic confidence and patient outcomes.
Intended Use
Clarify DL is a deep learning-based image reconstruction method intended to reduce noise and improve image quality of Nuclear Medicine bone SPECT scintigraphy images.
Technology
Clarify DL integrates an OSEM-based iterative image reconstruction with a deep learning model trained to reduce noise. It is deployed within the predicate Xeleris V Processing and Review System and StarGuide devices software, using their hardware and software platforms to produce images with improved contrast-to-noise ratios and contrast recovery coefficients.
Performance
The device underwent extensive bench testing including unit, integration, system, safety, and image performance verifications. It was tested for image quality metrics such as Structure Similarity Index Measure (SSIM), Mean Squared Error (MSE), Peak Signal-to-Noise Ratio (PSNR), as well as lesion-level metrics like Contrast-to-Noise Ratio (CNR) and Contrast Recovery Coefficient (CRC). Clinical evaluation involved expert nuclear medicine physicians reviewing image quality, resolution, and noise level on clinical bone SPECT and SPECT-CT exams from multiple hospitals, supporting substantial equivalence and diagnostic acceptability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/13/2024
7 months - 2
FDA Approval
1/3/2025
Other devices from GE Medical Systems Israel, Functional Imaging
- Aurora2025 • 510K
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