(55 days)
The Siemens Biograph Vision PET/CT 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 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 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.*
- 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 systems are combined multi-slice X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners. These systems are designed for whole body oncology, neurology and cardiology examinations.
The Biograph Vision 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 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 PET/CT, which is the subject of this application, is substantially equivalent to the commercially available Biograph mCT (K173578). The key difference between the Biograph mCT (predicate device) and the Biograph Vision PET/CT is the replacement of PhotoMultiplier Tubes (PMT) with Silicon PhotoMultipliers (SiPM). SiPMs are a photon sensitive technology built by combining a solid state photodiode array and a silicon substrate. The SiPMs allow close coupling to the scintillators (crystals) and a higher active area of detectors to scintillators. This combination results in superior performance compared to the photomultiplier tubes design used in previous generation PET block detectors.
The provided text is a 510(k) Summary for the Siemens Biograph Vision PET/CT system. It details the device, its intended use, and performance testing results to demonstrate substantial equivalence to a predicate device.
Acceptance Criteria and Device Performance:
The document primarily focuses on the physical performance characteristics of the PET component of the Biograph Vision system, tested according to NEMA NU2:2012 standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Criteria | Acceptance | Reported Device Performance |
|---|---|---|
| Resolution - Full Size | ||
| 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 |
| Count Rate / Scatter / Sensitivity | ||
| Sensitivity @435 keV LLD | ≥ 15.0 cps/kBq | Pass |
| Count Rate peak NECR | ≥250 kcps @ ≤ 32 kBq/cc | Pass |
| Count Rate peak trues | ≥1100 kcps @ ≤ 56 kBq/cc | Pass |
| Scatter Fraction at peak NECR | ≤43% | Pass |
| Mean bias (%) at peak NEC | ≤ 6% | Pass |
| Image Quality (4 to 1) - (% Contrast / Background Variability) | ||
| 10mm sphere | ≥ 55% / ≤ 10% | Pass |
| 13mm sphere | ≥ 60% / ≤ 9% | Pass |
| 17mm sphere | ≥ 65% / ≤8% | Pass |
| 22mm sphere | ≥ 70% / ≤7% | Pass |
| 28mm sphere | ≥ 75% / ≤ 6% | Pass |
| 37mm sphere | ≥ 80% / ≤ 5% | Pass |
Study Proving Device Meets Acceptance Criteria:
The study described is Performance Testing in accordance with NEMA NU2:2012, conducted on the Biograph Vision 600.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a "sample size" in terms of patient images or clinical cases. The testing appears to involve physical phantoms and measurements as per NEMA NU2:2012 standards, not a clinical test set of patient scans. Therefore, sample size in the context of clinical images is not applicable here.
- Data Provenance: Not applicable as this is performance testing of the device itself using phantom measurements, not clinical data collection. The testing was conducted by Siemens Medical Solutions USA, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. The ground truth for this type of performance testing is defined by the NEMA NU2:2012 standard itself, which specifies the phantoms, measurement procedures, and calculation methods. It does not involve human expert interpretation for establishing ground truth.
4. Adjudication Method for the Test Set:
Not applicable. As the testing involves objective physical measurements and calculations based on a recognized standard (NEMA NU2:2012), there is no need for human adjudication of results.
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:
No, an MRMC comparative effectiveness study was not done. The document describes a PET/CT scanner and its physical performance, not an AI-powered diagnostic tool requiring human reader studies to demonstrate improved performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in a sense, the performance testing described is "standalone" for the device's physical capabilities. The NEMA NU2:2012 tests evaluate the intrinsic imaging performance of the PET component (resolution, sensitivity, count rate, image quality based on phantom measurements) without human interpretation in the loop.
7. The Type of Ground Truth Used:
The ground truth used for this performance testing is the physical properties and known measurements of standardized phantoms as defined by the NEMA NU2:2012 standard. This is a technical ground truth, not a medical ground truth (like pathology, expert consensus, or outcomes data).
8. The Sample Size for the Training Set:
Not applicable. This is a hardware device (PET/CT scanner), not a machine learning algorithm that requires a "training set" of data for development.
9. How the Ground Truth for the Training Set was Established:
Not applicable for the same reason as above.
§ 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.