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Quantib Prostate

Quantib BV • Radiology • 05/13/2022

510(k)IEC 62304 Class B
FDA Summary PDF

Device Purpose

Quantib Prostate version 2.0 is an image post-processing software that enhances the analysis of prostate MRI scans by enabling automatic prostate and sub-region segmentation, multi-parametric image registration, and computation of a biparametric combination image, with user-interaction modules for editing, PI-RADS scoring, and PSA density determination. Its methodology relies on algorithms for automated processing combined with user-interactive tools for refinement, aiming to assist medical professionals in interpreting prostate MR studies and improve diagnostic workflow.

Summary

Quantib Prostate version 2.0 is an image post-processing software designed to assist trained medical professionals in the analysis and review of prostate MRI images. It functions as an extension to the Quantib AI Node software platform, providing functionalities such as registered multiparametric-MRI viewing, semi-automatic segmentation of anatomical structures with volume computations, tools for manual editing, and a structured workflow for PI-RADS scoring. The software aims to enhance the interpretation of prostate MR studies by providing additional mathematical and statistical analysis, with results displayable in various formats, including image overlays. Version 2.0 introduces significant modifications, most notably the division of prostate segmentation into prostatic sub-regions (central gland, peripheral zone, urethra) and the initialization of Region of Interest (ROI) location on the PI-RADS sector map. While the core prostate segmentation algorithm remains unchanged, the new sub-region segmentation can be exported, and its outer boundaries adjust with user edits to the main prostate segmentation. The software also expands its output formats to include PDF reports, DICOM RT structure sets, and DICOM segmentation storage. Non-clinical bench testing involved comparing automatic sub-region segmentation to ground truth using Dice overlap and Mean Surface Distance, while clinical performance was qualitatively assessed by radiologists using a Likert scale for sub-region segmentations and ROI initial localizations.

AI Regulatory Concerns

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Keywords

Prostate MRIImage processingSegmentationSub-region segmentationPI-RADSMultiparametric MRIROI localizationDICOMPSA densityMedical image analysis

Device Metadata

Submission Number
K221106
Company
Quantib BV
Panel
Radiology
Product Code
N/A
Data Type
Images
Clinical Function
Assessment
AI Function
Analysis
AI Subclass
quantification/feature localization

Relevant Clinical Questions

  • Q1. How does the performance of the automatic sub-region segmentation algorithm compare to inter-observer variability among expert radiologists in delineating these specific prostatic zones?; What is the quantitative impact of the ROI localization initialization on the PI-RADS sector map on the efficiency and accuracy of radiologists' lesion annotation and scoring?; Are there specific patient demographics or MRI acquisition protocols where the sub-region segmentation accuracy is notably higher or lower?; How does the biparametric combination image quantitatively improve lesion conspicuity or diagnostic confidence compared to viewing individual parametric maps separately?; What is the learning curve for trained medical professionals to proficiently use the new features, particularly the sub-region segmentation editing and ROI localization initialization?

Risk Classification

ESL Analysis
FDA Device ClassII

FDA Class II via 510(k) pathway; IEC 62304 Class B (software safety classification); Authorized before §524B enforcement

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Cybersecurity Evidence

Powered by SBOMator™

Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.

Cyber Score10/100
SBOM Evidence⚠ Not mentioned in summary
Cyber Risk Assessment⚠ Not mentioned in summary
Postmarket Plan⚠ Not mentioned in summary
§524B ApplicableNo

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials
- Not detected
ML-BOMMachine Learning Bill of Materials(algorithm, ground truth, annotation)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials(server, platform)
✓ Detected
HBOMHardware Bill of Materials
- Not detected
CBOMCryptography Bill of Materials
- Not detected
VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange
- Not detected
OBOMOperations Bill of Materials
- Not detected

Analysis:

• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.

• Evidence of ML-BOM, SaaSBOM detected in AI-generated device summary.

• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.

• Postmarket cybersecurity monitoring plan not clearly documented in AI-generated device summary.

• Not detected in AI-generated device summary: SBOM, HBOM, CBOM, VDR/VEX, OBOM. These may be present in the full FDA submission.

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Quantib Prostate - Quantib BV | ESL FDA AI Device Intelligence