(30 days)
The Siemens Biograph Vision Quadra PET/CT systems are combined Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration 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 axial 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 the 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 health care professionals to aid in detecting, localizing, diagnosing, staging 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 *
- As 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 Vision Quadra PET/CT 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 Vision and 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 Vision Quadra 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 Biograph Vision Quadra is an extended Field of View scanner based on the Biograph Vision 600 Edge scanner. The system incorporates the same CT on the Biograph Vision 600 Edge but incorporates a 106 cm axial PET FoV. The gantry mechanical frame has been updated to support four (4) times the detectors available on the Biograph Vision 600 systems.
The software for the Biograph Vision Quadra systems, which are the subject of this application, is substantially equivalent to the commercially available Biograph Vision software (K193248). Modifications have been made to the commercially available Biograph Vision software to provide for acquisition and reconstruction of the additional detectors associated with the extended axial FoV of the PET system.
Additionally, modifications have been made to the PET computers to ensure that the system computing can handle the amount of data received from the 1 m scan range system.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Criteria (NEMA NU2-2018) | Acceptance Criteria ("Acceptance") | Reported Device Performance ("Results") |
|---|---|---|
| For Maximum Ring Difference (MRD) of 85: | ||
| Transverse Resolution FWHM @ 1 cm | ≤ 4.0 mm | Pass |
| Transverse Resolution FWHM @ 10 cm | ≤ 4.8 mm | Pass |
| Transverse Resolution FWHM @ 20 cm | ≤ 5.2 mm | Pass |
| Axial Resolution FWHM @ 1 cm | ≤ 4.3 mm | Pass |
| Axial Resolution FWHM @ 10 cm | ≤ 5.4 mm | Pass |
| Axial Resolution FWHM @ 20 cm | ≤ 5.4 mm | Pass |
| Sensitivity @435 keV LLD | ≥ 70 cps/kBq | Pass |
| Count Rate peak NECR | ≥ 1060 kcps @ ≤ 20 kBq/cc | Pass |
| Count Rate peak trues | ≥ 2680 kcps @ ≤ 20 kBq/cc | Pass |
| Scatter Fraction at peak NECR | ≤ 43% | Pass |
| Mean bias (%) at NEC of 1060 kcps | [-6, 6] | Pass |
| Co-Registration Accuracy | ≤ 5 mm | Pass |
| Time of Flight Resolution at 5.3 kBq/cc | ≤ 249 ps | Pass |
| 10mm sphere (Contrast / Background Variability) | ≥ 55.0% / ≤ 10.0% | Pass |
| 13mm sphere (Contrast / Background Variability) | ≥ 60.0% / ≤ 9.0% | Pass |
| 17mm sphere (Contrast / Background Variability) | ≥ 65.0% / ≤ 8.0% | Pass |
| 22mm sphere (Contrast / Background Variability) | ≥ 70.0% / ≤ 7.0% | Pass |
| 28mm sphere (Contrast / Background Variability) | ≥ 75.0% / ≤ 6.0% | Pass |
| 37mm sphere (Contrast / Background Variability) | ≥ 80.0% / ≤ 5.0% | Pass |
| Lung Residual Error | ≤ 5.0% | Pass |
| For Maximum Ring Difference (MRD) of 322: | ||
| Sensitivity @435 keV LLD | ≥ 150 cps/kBq | Pass |
| Count Rate peak NECR | ≥ 1940 kcps @ ≤ 20 kBq/cc | Pass |
| Count Rate peak trues | ≥ 5130 kcps @ ≤ 20 kBq/cc | Pass |
| Scatter Fraction at peak NECR | ≤ 43% | Pass |
| Time of Flight Resolution at 5.3 kBq/cc | ≤ 249 ps | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance testing was conducted according to NEMA NU2-2018 standards, which typically involve testing on phantoms rather than human or animal subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a ground truth for the test set. The performance testing appears to be based on objective measurements against NEMA NU2-2018 industrial standards, which are defined by physical phantoms and measurement protocols, not expert consensus on pathology or clinical outcomes.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as the testing involves objective physical measurements against established standards (NEMA NU2-2018) rather than subjective assessments by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document describes performance testing of the device's physical and technical characteristics, not its performance in a clinical setting with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The performance testing described is for the "algorithm only" (i.e., the Biograph Vision Quadra PET/CT System's technical performance) without a human reader in the loop. The "Results" column indicating "Pass" for all tested criteria confirms that the system, as a standalone device, met the predetermined acceptance values.
7. Type of Ground Truth Used
The ground truth used for the performance testing is based on the NEMA NU2-2018 standard. This standard specifies phantoms and measurement protocols to objectively evaluate the physical performance characteristics of PET systems. It is not based on expert consensus, pathology, or outcomes data, but rather on direct physical measurements against defined benchmarks.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of the described performance testing. The Biograph Vision Quadra PET/CT System is a medical imaging device (hardware and associated software), and the performance testing focuses on its physical and technical specifications rather than an AI model that undergoes a training phase. While there is software development involved ("Modifications have been made to the commercially available Biograph Vision software"), the document does not detail specific training data for that software in the context of this performance evaluation.
9. How the Ground Truth for the Training Set Was Established
As no training set is described in the context of the performance testing for this device's NEMA NU2-2018 criteria, information on how its ground truth was established is not provided.
§ 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.