Saige Prostate (QUANTIB® Prostate)

DeepHealth
The artificial intelligence-based software, Saige Prostate (previously Quantib® Prostate), provides a workflow for detection of abnormalities on MRI prostate scans.
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Information source: Vendor
Last updated: Dec. 19, 2023

General Information

General
Product name Saige Prostate (QUANTIB® Prostate)
Company DeepHealth
Subspeciality Abdomen
Modality MR
Disease targeted Prostate cancer
Key-features Prostate gland and zone volume measurements, PSA density calculation, AI-supported ROI segmentation, PI-RADS v.2.1 scoring support, structured report
Suggested use During: perception aid (prompting all abnormalities/results/heatmaps), interactive decision support (shows abnormalities/results only on demand), report suggestion

Technical Specifications

Data characteristics
Population Prostate MRI scans with suspicion of prostate cancer
Input MRI, T2, DWI, DCE (optional)
Input format DICOM
Output Segmentation overlays, segmentation series, a structured report with key images and PI-RADS
Output format DICOM
Technology
Integration Integration in standard reading environment (PACS), DICOM-based integration via own zero footprint AI platform
Deployment Locally on dedicated hardware, Cloud-based
Trigger for analysis Automatically, right after the image acquisition, On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time 1 - 10 minutes

Regulatory

Certification
CE
Certified, Class IIb , MDR
FDA 510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE) Quantib Prostate is image post-processing software that provides the user with processing, visualization, and editing of prostate MR images. The software facilitates the analysis and study review of MR data sets and provides additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including images overlaid onto source MR images. Quantib Prostate functionality includes registered multiparametric-MRI viewing, with the option to view images combined into a single image to support visualization. The software can be used for semi-automatic segementation of anatomical structures and provides volume computations, together with tools for manual editing. PI-RADS scoring is possible using a structured workflow. Quantib Prostate is intended to be used by trained medical professionals and provides information that, in a clinical setting, may assist in the interpretation of prostate MR studies. Diagnosis should not be made solely based on the analysis performed using Quantib Prostate.

Market

Market presence
On market since 10-2020
Distribution channels Calantic
Countries present (clinical, non-research use)
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model Pay-per-use, Subscription
Based on Number of installations, Number of analyses

Evidence

Evidence
Peer reviewed papers on performance

  • Prospective effects of an artificial intelligence-based computer-aided detection system for prostate imaging on routine workflow and radiologists’ outcomes (read)

  • Bridging the experience gap in prostate multiparametric magnetic resonance imaging using artificial intelligence: A prospective multi-reader comparison study on inter-reader agreement in PI-RADS v2.1, image quality and reporting time between novice and expert readers (read)

  • Quantib Prostate Compared to an Expert Radiologist for the Diagnosis of Prostate Cancer on mpMRI: A Single-Center Preliminary Study (read)

  • Biparametric prostate MRI: impact of a deep learning-based software and of quantitative ADC values on the inter-reader agreement of experienced and inexperienced readers (read)
Non-peer reviewed papers on performance
Other relevant papers