(30 days)
Siemens mCT systems are combined X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
The CT component produces cross-sectional images of the body by computer reconstruction of X-ray transmission data from either the same plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.
The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and/or PET diagnostic imaging.
These systems are intended to be utilized by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.
This CT system can be used for low dose lung cancer screening in high risk populations. (High risk population has been defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.)
The Biograph mCT family systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph mCT systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.
Biograph mCT software is a command based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The software for the Biograph mCT systems which is the subject of this application is substantially equivalent to the commercially available Biograph mCT software. Modifications include:
- Somaris Software (cleared in K152036)
- o Upgrade to the latest revision of Somaris Software
- PETsyngo software ●
- Update of the software to add Low CT Does Protocols for PET AC O
- Update to add Wholebody Scatter Correction O
- QualityGuard O
- FlowMotion Multi-Parametric PET O
- O OncoFreeze
- o CardioFreeze
- Shuttle Mode PET Acquisition o
- Parallel Reconstruction O
- PET Dose Report O
- TeamViewer O
- Maximum Patient Clearance Mode o
- Smart Mobile Connect o
- O Update of the software corrections
- Update of the TrueD software component O
- Address anomalies
- Update to improve usability and viewing of Multi-Parametric PET imaqes
- Improvements to workflow o
- Improvements to performance (faster reconstruction speeds) о
This document describes the performance testing for the Siemens Biograph mCT and mCT Flow PET/CT Scanners (K173578). This is not an AI/ML device, therefore, some of the requested information (e.g., training set, expert adjudication, MRMC study, standalone performance) is not applicable.
1. Table of Acceptance Criteria and Reported Device Performance:
The performance testing was conducted in accordance with NEMA NU2:2012. The following table summarizes the acceptance criteria and the "Pass" results reported for two different configurations (3-ring and 4-ring versions) of the Biograph mCT systems.
| Performance Criteria | Acceptance | Reported Device Performance |
|---|---|---|
| Resolution - Full Size | ||
| Transverse Resolution FWHM @ 1 cm | ≤ 4.7 mm | Pass |
| Transverse Resolution FWHM @ 10 cm | ≤ 5.4 mm | Pass |
| Transverse Resolution FWHM @ 20 cm | ≤ 6.3 mm | Pass |
| Axial Resolution FWHM @ 1 cm | ≤ 4.9 mm | Pass |
| Axial Resolution FWHM @ 10 cm | ≤ 6.5 mm | Pass |
| Axial Resolution FWHM @ 20 cm | ≤ 8.8 mm | Pass |
| Resolution - 256 x 256 | ||
| Transverse Resolution FWHM @ 1 cm | ≤ 7.3 mm | Pass |
| Transverse Resolution FWHM @ 10 cm | ≤ 7.5 mm | Pass |
| Transverse Resolution FWHM @ 20 cm | ≤ 7.7 mm | Pass |
| Axial Resolution FWHM @ 1 cm | ≤ 6.0 mm | Pass |
| Axial Resolution FWHM @ 10 cm | ≤ 6.6 mm | Pass |
| Axial Resolution FWHM @ 20 cm | ≤ 9.2 mm | Pass |
| Count Rate / Scatter / Sensitivity | ||
| Sensitivity @435 keV LLD | ≥ 5.0 cps/kBq | |
| ≥ 9.4 cps/kBq (TrueV) | Pass | |
| Count Rate peak NECR | ≥ 95 kcps @ ≤ 30 kBq/cc | |
| ≥ 165 kcps @ ≤ 28 kBq/cc (TrueV) | Pass | |
| Count Rate peak trues | ≥ 350 kcps @ ≤ 46 kBq/cc | |
| ≥ 575 kcps @ ≤ 40 kBq/cc (TrueV) | Pass | |
| Scatter Fraction at peak NECR | ≤ 40% | Pass |
| Mean bias (%) at peak NEC | +/- 6% | Pass |
| Image Quality (4 to 1) - (% Contrast / Background Variability) | ||
| 10mm sphere | ≥ 10% / ≤ 10% | Pass |
| 13mm sphere | ≥ 25% / ≤ 10% | Pass |
| 17mm sphere | ≥ 40% / ≤ 10% | Pass |
| 22mm sphere | ≥ 55% / ≤ 10% | Pass |
| 28mm sphere | ≥ 55% / ≤ 10% | Pass |
| 37mm sphere | ≥ 60% / ≤ 10% | Pass |
2. Sample size used for the test set and data provenance:
The document states that performance testing was conducted on two different configurations of the Biograph mCT systems: a 3-ring version and a 4-ring version. The testing was performed in accordance with NEMA NU2:2012, which typically involves standardized phantom studies rather than patient data. Therefore, the "sample size" refers to the number of phantom configurations tested. The data provenance is laboratory-based phantom testing, not patient data from a specific country or retrospective/prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the performance testing for a PET/CT scanner, according to NEMA NU2:2012 standards, relies on objective measurements from physical phantoms rather than human expert interpretation or ground truth establishment in a clinical context.
4. Adjudication method for the test set:
This information is not applicable as the performance testing for a PET/CT scanner, according to NEMA NU2:2012 standards, relies on objective measurements from physical phantoms rather than human expert interpretation or adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a PET/CT scanner, a medical imaging hardware system, not an AI-powered diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a PET/CT scanner, a hardware system with integrated software, not a standalone algorithm. Performance is assessed through physical measurements, not algorithmic output on its own.
7. The type of ground truth used:
The ground truth for this type of device is established by the physical properties of the phantoms used in the NEMA NU2:2012 testing. These phantoms have known dimensions, radioactive concentrations, and other physical characteristics that serve as the "true" values against which the scanner's measurements are compared.
8. The sample size for the training set:
This is not applicable. The device is a PET/CT scanner, which is a medical imaging hardware system. It does not employ machine learning that requires a "training set" in the conventional AI sense.
9. How the ground truth for the training set was established:
This is not applicable for the same reasons as #8.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.