Quantib Prostate

MRI prostate

Image post-processing software for processing, visualization, and editing of prostate MRI images. Supports registered multi-parametric MRI viewing, semi-automatic AI-based segmentation of anatomical structures (prostate gland and sub-regions), volume computations, manual editing tools, and PI-RADS structured workflow. Diagnosis should not be made solely based on Quantib Prostate analysis.

Regulatory

Regulatory status	510(k) cleared
FDA decision date	2023-04-17
FDA 510(k) number	K230772
CE marked	Yes

Validation summary

Partial validation summary — some fields are still unverified. See limitations note below.

Study design	Retrospective
Cohort size	FDA Special 510(k) bench testing only — sample size for the subregion-segmentation Dice/MSD comparison not disclosed in the public Decision Summary. Predicate clinical performance (Quantib Prostate v2.0, K221106) was leveraged. Peer-reviewed Chiacchio 2025 in La Radiologia Medica and Faiella 2022 in Diagnostics provide independent real-world csPCa detection cohorts (curator should populate full cohort sizes from those full texts).
Number of validation sites	—
Site geography	—
Comparator	Predicate device
Primary endpoint	Concordance (C-index)
Primary result	FDA K230772 bench testing: automatic segmentations compared to ground truth via Dice overlap and Mean Surface Distance; results stated 'as safe and effective as the predicate device'. Quantitative Dice/MSD values not disclosed in the public Decision Summary text. Qualitative reader Likert scoring concluded sub-region segmentations and ROI initial localizations 'are judged at least as accurate as the predicate device'.
External validation	Yes — Independent external evaluations exist in peer-reviewed literature. Per Chiacchio 2025 (La Radiologia Medica), Quantib did not enhance csPCa detection in experienced readers but did improve performance for inexperienced readers; Faiella 2022 reported inter-reader agreement (weighted κ ≈ 0.45–0.46) and shorter reporting time with Quantib. · Mixed real-world evidence: benefit appears concentrated in less-experienced readers.
Peer-reviewed	Yes
FDA decision summary	View on accessdata.fda.gov

Key publications

The added value of artificial intelligence using Quantib Prostate for the detection of prostate cancer at multiparametric magnetic resonance imaging
La Radiologia Medica · 2025
Quantib Prostate Compared to an Expert Radiologist for the Diagnosis of Prostate Cancer on mpMRI: A Single-Center Preliminary Study
Diagnostics · 2022

Limitations noted

[Source-detail preserved: Study design: Single-center; Primary endpoint (original): dice_coefficient] (i) K230772 is a Special 510(k) — relies heavily on predicate K221106 for clinical performance; current Decision Summary discloses bench only; (ii) no MRMC reader study or AUC/sensitivity/specificity metrics in K230772 public summary; (iii) peer-reviewed evidence mixed — benefit may be limited to less-experienced readers; (iv) curator should review prior predicate K221106 / K202501 for full historical clinical metrics.

Deployment

Available

Yes

Sources

https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230772.pdf · fda_db · 2026-05-12
https://pubmed.ncbi.nlm.nih.gov/40332649/ · publication · 2026-05-12
https://pmc.ncbi.nlm.nih.gov/articles/PMC9415513/ · publication · 2026-05-12

How to cite this entry

Elbakri A. OncologyAI Registry: Quantib Prostate. Available at: https://oncologyairegistry.org/tools/quantib-prostate.html. Accessed [date].