(65 days)
The Siemens Biograph Horizon 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 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 Horizon 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 Horizon 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 Horizon 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 Bioqraph Horizon systems which is the subject of this application is substantially equivalent to the commercially available Biograph Horizon software. Modifications include:
- . Corrections to software anomalies and addition of new software features, including:
- Continuous Bed Motion O
- o HD·Chest (including Stitched HD Chest)
- Whole Body Gating O
- HD FoV for Attenuation Correction о
- Phased Matched Gating O
- Low Dose CT Protocols for PET AC O
- SMART Mobile Connect O
- PET Dose Report O
- Enhanced IT Security O
- Scan Protocol Management o
- TeamViewer O
- Dual Topo O
- True Stack O
Additionally, minor modifications have been made to the patient bed electronics due to obsolescence issues. These changes do not affect system performance characteristics and have no impact on safety or effectiveness.
The provided text is a 510(k) Summary for the Siemens Biograph Horizon PET/CT system. It details the device, its intended use, and performance testing results. Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance
| Performance Criteria | Acceptance | Reported Device Performance |
|---|---|---|
| Resolution - Full Size | ||
| Transverse Resolution FWHM @ 1 cm | ≤ 4.7 mm | Pass |
| Transverse Resolution FWHM @ 10 cm | ≤ 5.5 mm | Pass |
| Transverse Resolution FWHM @ 20 cm | ≤ 7.6 mm | Pass |
| Axial Resolution FWHM @ 1 cm | ≤ 5.0 mm | Pass |
| Axial Resolution FWHM @ 10 cm | ≤ 7.0 mm | Pass |
| Axial Resolution FWHM @ 20 cm | ≤ 11.3 mm | Pass |
| Resolution - 256 x 256 | ||
| Transverse Resolution FWHM @ 1 cm | ≤ 7.3 mm | Pass |
| Transverse Resolution FWHM @ 10 cm | ≤ 7.6 mm | Pass |
| Transverse Resolution FWHM @ 20 cm | ≤ 8.9 mm | Pass |
| Axial Resolution FWHM @ 1 cm | ≤ 6.1 mm | Pass |
| Axial Resolution FWHM @ 10 cm | ≤ 7.3 mm | Pass |
| Axial Resolution FWHM @ 20 cm | ≤ 11.9 mm | Pass |
| Count Rate / Scatter / Sensitivity | ||
| Sensitivity @435 keV LLD | ≥ 5.8 cps/MBq | |
| ≥ 10.9 cps/MBq (TrueV) | Pass | |
| Count Rate peak NECR | ≥ 78 kcps @ ≤ 26 kBq/cc | |
| ≥ 135 kcps @ ≤ 26 kBq/cc (TrueV) | Pass | |
| Count Rate peak trues | ≥285 kcps @ ≤ 53 kBq/cc | |
| ≥ 465 kcps @ ≤ 42 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 |
All performance testing met the predetermined acceptance values.
2. Sample Size Used for the Test Set and the Data Provenance
The document states that "PET Testing in accordance with NEMA NU2:2012 was conducted on two different configurations of the Biograph Horizon systems, a 3 ring version and a 4 ring version (TrueV)." NEMA NU2:2012 is a standard for the performance measurements of PET scanners, typically utilizing phantoms rather than human or clinical data. Therefore, the "test set" in this context refers to measurements taken on the physical systems using standardized phantoms. The document does not specify a separate sample size (e.g., number of patients or data points) beyond testing the two system configurations. The data provenance is derived from these physical system tests, not from a specific country of origin or clinical retrospective/prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Given that the performance testing was conducted according to NEMA NU2:2012, which involves standardized measurements using phantoms, the concept of "experts" establishing ground truth in a clinical sense (e.g., radiologists reviewing images) is not applicable here. The "ground truth" for this type of testing is established by the known physical properties and radioactive concentrations within the phantoms used, as measured against the NEMA standard.
4. Adjudication Method for the Test Set
As the performance testing against NEMA NU2:2012 involves direct physical measurements and calculations based on phantom acquisitions, there is no mention of a human adjudication method (like 2+1 or 3+1 consensus) in the document. The "Pass" results indicate that the measured values fell within the predefined acceptance ranges.
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
The provided document describes performance testing of a PET/CT scanner against technical standards (NEMA NU2:2012). It does not mention any multi-reader multi-case (MRMC) comparative effectiveness studies, nor any AI assistance to human readers. Therefore, no effect size for human reader improvement with/without AI can be determined from this document.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document details the performance characteristics of the PET/CT hardware system. It refers to software modifications but these are for anomaly corrections and new features (e.g., Continuous Bed Motion, HD·Chest), not for an "algorithm only" standalone performance evaluation in a diagnostic context. The core performance testing focuses on the system's physical capabilities as measured by NEMA NU2:2012.
7. The Type of Ground Truth Used
The ground truth used for the performance testing was based on physical phantom measurements in accordance with the NEMA NU2:2012 standard. This standard defines precise methodologies for measuring metrics like resolution, sensitivity, and image quality using phantoms with known characteristics.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI. The testing performed is related to the physical performance of the PET/CT system hardware, not a data-driven model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of the device's performance evaluation in this document, the method for establishing its "ground truth" is not applicable or described.
§ 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.