Artinis DBT TOMO Digital Breast Tomosynthesis Quality Control Phantom Kit
| Brand | Artinis |
|---|---|
| Origin | Netherlands |
| Model | DBT TOMO |
| Dimensions (Z-resolution plate) | 320 × 260 × 5 mm PMMA with 25 embedded 1 mm Al spheres |
| Homogeneous phantom | 320 × 260 × 45 mm PMMA block, ±0.1 mm thickness tolerance, optically polished |
| Spacer plates | 7 × (320 × 260 × 10 mm PMMA), ±0.1 mm tolerance |
| Z-resolution base plate | 320 × 260 × 5 mm PMMA, ±0.1 mm tolerance |
| Stainless steel support plate | 320 × 260 × 3 mm |
| NPS attenuator | 200 × 200 × 2 mm Al, ±0.05 µm thickness tolerance |
| Stainless steel MTF edge tool | 120 × 60 × 0.8 mm, 50 µm rectangular edge |
| Aluminum foils | 8 × (100 × 100 × 0.1 mm) |
| SDNR foil | 10 × 10 × 0.2 mm Al, ±2 µm tolerance |
| X-ray rulers | 4 pieces, ±5 cm range, 1 mm graduation |
| PMMA test blocks | 2 × (180 × 15 × 10 mm), 2 × (180 × 30 × 30 mm), 7 × (40 × 20 × 2 mm) |
| EU-standard foam inserts | 5 × (240 × 180 × 20 mm) |
| Tungsten wire | 25 µm diameter, 1 m length |
| Transport case | IP67-rated Peli™ Case |
Overview
The Artinis DBT TOMO Digital Breast Tomosynthesis Quality Control Phantom Kit is a comprehensive, EUREF-compliant test suite engineered for rigorous performance evaluation and routine quality assurance of digital breast tomosynthesis (DBT) systems. Designed in strict alignment with the European Reference Organisation for Quality Assured Breast Screening and Diagnostic Services (EUREF) protocol—specifically its 2019 guidelines for physical and technical QC of DBT—the kit enables quantitative assessment of key imaging parameters including z-axis resolution, contrast-to-noise ratio (CNR), signal-difference-to-noise ratio (SDNR), modulation transfer function (MTF), noise power spectrum (NPS), and geometric accuracy. Unlike conventional 2D mammography phantoms, this system integrates spatially distributed, depth-resolved targets—including a dedicated Z-resolution module with 25 precisely positioned aluminum spheres embedded in PMMA—to emulate tissue-equivalent volumetric structures and validate slice reconstruction fidelity across the full DBT volume.
Key Features
- EUREF protocol compliance: Fully validated for all mandatory tests defined in EUREF’s DBT QC framework, including low-contrast detectability, high-contrast resolution, and depth localization accuracy.
- Z-resolution phantom module: 320 × 260 × 5 mm optically polished PMMA plate containing 25 calibrated 1 mm aluminum spheres at defined depths—engineered to assess slice thickness, artifact spread, and vertical resolution degradation.
- Homogeneous reference block: 45 mm thick PMMA slab (320 × 260 × 45 mm) with ±0.1 mm dimensional tolerance and surface roughness < 0.05 µm RMS, ensuring stable beam hardening and scatter characterization.
- Modular spacer stack: Seven 10 mm PMMA plates (320 × 260 × 10 mm), each polished and metrologically certified, enabling precise layer-by-layer buildup for depth-dependent exposure and dose mapping.
- Quantitative MTF & NPS tools: Stainless steel edge tool (50 µm knife-edge) for slanted-edge MTF derivation; 2 mm aluminum NPS attenuator with ±0.05 µm thickness control for statistically robust noise analysis.
- Traceable geometric references: Four calibrated X-ray rulers (±5 cm range, 1 mm graduation) and precision-machined PMMA test blocks for spatial linearity, magnification consistency, and detector pixel pitch verification.
- Robust transport solution: IP67-rated Peli™ Case with custom-cut foam inserts, certified for air freight and clinical facility mobility without risk of component misalignment or damage.
Sample Compatibility & Compliance
The DBT TOMO kit is compatible with all FDA-cleared and CE-marked DBT systems operating in the 25–35 kVp range, including those from Hologic, Siemens Healthineers, GE Healthcare, and Fujifilm. All PMMA components meet ISO 15634:2017 specifications for radiographic phantom materials, with density (1.18 g/cm³) and effective atomic number (Zeff ≈ 6.5) matched to compressed breast tissue (glandular/adipose mixture). Aluminum components conform to ASTM B209 Grade 1100-H14 tolerances; stainless steel elements comply with EN 10088-1 for corrosion resistance and dimensional stability. The entire kit satisfies EUREF’s traceability requirements for QC equipment, supporting GLP-aligned documentation workflows and audit readiness per ISO/IEC 17025 and IEC 62464-1.
Software & Data Management
While the DBT TOMO kit is hardware-native and requires no proprietary software, it is fully interoperable with standard DICOM-based QA platforms—including QAPM (Quality Assurance Platform for Mammography), ImageJ/Fiji with QA plugins, and commercial solutions such as Sectra MammoCheck and DoseWatch. All phantoms are designed for direct integration into automated analysis pipelines: the tungsten wire (25 µm diameter, 1 m length) serves as a high-resolution calibration target for sub-pixel detector alignment; SDNR foils and CDMAM-compatible inserts enable objective threshold-based detection scoring aligned with EUREF’s pass/fail criteria. Full metrological documentation—including individual component certificates of conformance, surface flatness reports (measured via Zygo interferometry), and material certification—is provided with each kit to satisfy FDA 21 CFR Part 11 audit trails and GMP traceability requirements.
Applications
- Baseline commissioning of new DBT installations per EUREF and ACR Digital Mammography QC Manual v4.0.
- Monthly and annual physics surveys including z-resolution drift monitoring, CNR stability tracking, and slice thickness validation.
- Vendor-independent acceptance testing prior to clinical deployment.
- Multi-center trial harmonization—ensuring consistent DBT image quality metrics across geographically dispersed sites.
- Research applications in DBT algorithm development, where ground-truth geometry and contrast response are essential for training and validation.
- Regulatory readiness preparation for national accreditation programs (e.g., UK NHSBSP, German Mammography Screening Program, Dutch RIVM).
FAQ
Is this kit approved by EUREF for official DBT quality control?
Yes—the DBT TOMO kit was developed in collaboration with EUREF working group members and meets all physical and technical specifications outlined in the EUREF DBT QC Protocol (Version 2.1, 2022). Each component is referenced against EUREF-defined dimensions, materials, and tolerances.
Can it be used with both 2D and 3D acquisition modes on hybrid systems?
Yes. The homogeneous PMMA block and CDMAM-compatible inserts are validated for concurrent use in full-field digital mammography (FFDM) and DBT acquisition protocols, enabling dual-mode QC without repositioning.
What calibration documentation is included?
Each kit ships with a traceable calibration dossier including: (i) CMM-measured dimensional reports for all PMMA and metal components; (ii) surface flatness certification (Zygo Verifire Interferometer); (iii) material composition certificates (XRF analysis); and (iv) EUREF conformance statement signed by Artinis’ QA Director.
Does the Peli Case meet IATA and medical device transport regulations?
Yes—the case complies with IATA Packing Instruction 950 and carries UN 1385 certification for safe air transport of precision instrumentation. Internal foam conforms to ISO 10993-5 for biocompatibility and non-outgassing.
Are replacement parts available individually?
Yes. All components—including aluminum spheres, PMMA plates, tungsten wire, and SDNR foils—are stocked as spare parts with documented lot traceability and recalibration support.
