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510(k) Data Aggregation
(57 days)
The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of physiologic and anatomic information.
The CT component produces cross-sectional images of the body by computer reconstruction of X-Rav 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)
The Biograph PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. This system is designed for whole body oncology, neurology and cardiology examinations. The Biograph PET/CT 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 VK10 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 PET/CT systems which are the subject of this application are substantially equivalent to the commercially available Biograph Vision family of PET/CT systems (K193248). Differences compared to the Biograph Vision systems include:
- The PET system is an air cooled SiPM system. The detectors, electronics, etc. are similar to the Biograph Vision. Modifications have been made to produce a costeffective SiPM system while bringing high end features to that market.
- . Commercially available go. systems (K211373) have been incorporated as the CT system. This provides for updated workflows, interfaces, etc. to allow the health personnel interact more closely with the patients.
- The software integrated into the system is a combination of the CT software (K211373) with PET software with features similar to / based on the Biograph Vision systems (K193248).
- . The Patient Handling System has been updated to increase the weight limit allowing access to more bariatric patients.
The Biograph VK10 is designed as a scalable system with varying PET axial FoV's and different CT configurations. Hardware and software upgrades are available.
The provided text is a 510(k) summary for the Siemens Biograph VK10 PET/CT system. It focuses on demonstrating substantial equivalence to a predicate device and includes performance testing results based on NEMA NU 2:2018 standards. However, it does not provide information about a study proving the device meets acceptance criteria related to AI/algorithm performance with human users or standalone AI performance, ground truth establishment for a test set, expert involvement, or MRMC studies.
The "Performance Testing / Safety and Effectiveness" section explicitly states: "Performance testing for the CT subsystem was included in the original premarket notification for the CT subsystems and there have been no changes affecting this testing. PET Testing in accordance with NEMA NU 2: 2018 was conducted on the system." This indicates the performance data relates to the physical imaging capabilities of the PET/CT system, not an AI component.
Therefore, many of the requested details, particularly those related to AI model evaluation (e.g., sample size for test/training sets for an AI model, expert ground truth, MRMC studies, standalone algorithm performance), cannot be extracted from this document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is available for the PET system's physical performance, based on NEMA NU 2:2018.
| Performance Criteria | Reported Performance (Results) | Acceptance Criteria (Values) |
|---|---|---|
| Resolution - Full Size | ||
| Transverse Resolution FWHM @ 1 cm | Pass | ≤ 4.5 mm (Axial FoV 1) |
| Transverse Resolution FWHM @ 10 cm | Pass | ≤ 5.0 mm (Axial FoV 1) |
| Transverse Resolution FWHM @ 20 cm | Pass | ≤ 5.8 mm (Axial FoV 1) |
| Axial Resolution FWHM @ 1 cm | Pass | ≤ 4.7 mm (Axial FoV 1) |
| Axial Resolution FWHM @ 10 cm | Pass | ≤ 5.5 mm (Axial FoV 1) |
| Axial Resolution FWHM @ 20 cm | Pass | ≤ 6.1 mm (Axial FoV 1) |
| Sensitivity @435 keV LLD | Pass | ≥ 6.7 cps/kBq (Axial FoV 1), ≥ 12.0 cps/kBq (Axial FoV 2) |
| Count Rate peak NECR | Pass | ≥60 kcps @ ≤ 25 kBq/cc (Axial FoV 1), ≥110 kcps @ ≤ 25 kBq/cc (Axial FoV 2) |
| Count Rate peak trues | Pass | ≥180 kcps @ ≤ 35 kBq/cc (Axial FoV 1), ≥320 kcps @ ≤ 35 kBq/cc (Axial FoV 2) |
| Scatter Fraction at peak NECR | Pass | ≤43% (Axial FoV 1) |
| Co-Registration Accuracy | Pass | ≤ 5 mm |
| Time of Flight Resolution at 5.3kBq/cc | Pass | ≤ 274 ps |
| 10mm sphere (Contrast / Background Variability) | Pass | ≥ 30% / ≤ 9% |
| 13mm sphere (Contrast / Background Variability) | Pass | ≥ 40% / ≤ 8% |
| 17mm sphere (Contrast / Background Variability) | Pass | ≥ 55% / ≤ 6% |
| 22mm sphere (Contrast / Background Variability) | Pass | ≥ 65% / ≤ 5% |
| 28mm sphere (Contrast / Background Variability) | Pass | ≥ 70% / ≤ 4% |
| 37mm sphere (Contrast / Background Variability) | Pass | ≥ 80% / ≤ 3% |
| Lung Residual Error | Pass | ≤ 10% |
The study that proves the device meets the acceptance criteria:
The document states: "PET Testing in accordance with NEMA NU 2: 2018 was conducted on the system. All Performance testing met the predetermined acceptance values." This indicates that a testing procedure following the NEMA NU 2:2018 standard was performed to verify the physical performance characteristics of the PET component of the Biograph VK10.
Regarding AI/Software performance specific to the detailed criteria (2-9):
The provided document does not contain the necessary information to answer these questions, as it describes the 510(k) clearance process for a PET/CT imaging system based on its hardware and basic software functionalities (image reconstruction, archival, evaluation), rather than an AI/ML-driven diagnostic or assistive algorithm. The "software integrated into the system is a combination of the CT software (K211373) with PET software with features similar to / based on the Biograph Vision systems (K193248)". This suggests conventional software, not an AI model that would require training sets, expert ground truth for test sets, MRMC studies, etc.
Therefore, for questions 2 through 9, the answer based on the provided text is: Information not provided in this document.
To reiterate: This 510(k) summary focuses on the substantial equivalence of a medical imaging device (PET/CT scanner) based on its hardware specifications and traditional software functions, as evaluated against established performance standards (NEMA NU 2:2018). It does not discuss the evaluation of an AI or machine learning component that would necessitate the types of studies outlined in your detailed request (MRMC, standalone algorithm performance, specific ground truth methods, training/test set details for AI).
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