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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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(29 days)
The Siemens Symbia Pro.specta VA20A Family is intended for use by appropriately wained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, turnors, 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 or additional uses.
SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: planar imaging, and tomographic imaging for isotopes with energies up to 588 keV.
CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes taken at different angles.
SPECT+CT: The SPECT and CT components used together acquire SPECT/CT images. The SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.
Software: The SPECTsyngo software is an acquisition, display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT, and other imaging modalities.
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 Siemens Symbia Pro.specta VA20A Family consists of Single-Photon Emission Computed Tomography (SPECT) scanner and integrated hybrid x-ray Computed Tomography (CT) and SPECT scanner.
The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates CT's anatomical detail for precise reference of the location of the metabolic activity.
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 system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as stand-alone diagnostic imaging devices.
Siemens Symbia Pro.specta VA20A Family maintains the same intended use and indications for use as the commercially available Symbia Pro.specta VA10A family (K212604).
The provided text describes a 510(k) premarket notification for the Siemens Symbia Pro.specta VA20A Family, which is a hybrid SPECT/CT imaging system. The submission claims substantial equivalence to a predicate device (Symbia Pro.specta VA10A family, K212604), and therefore, the information provided focuses on demonstrating that the new device does not raise new questions of safety or effectiveness and maintains comparable performance.
It's important to note that a 510(k) submission primarily relies on demonstrating equivalence rather than conducting de novo clinical performance studies for the entire system's diagnostic accuracy. As such, the information on "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be focused on engineering and performance testing to demonstrate that the changes implemented do not degrade the established performance of the predicate device, rather than a clinical study evaluating diagnostic accuracy (e.g., against human readers).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily related to maintaining or improving the technical performance of the imaging components (SPECT and CT) and the software, without introducing new risks or altering the fundamental scientific technology or intended use.
| Acceptance Criteria Category | Specific Acceptance Criteria (Target Performance/Specification) | Reported Device Performance (as stated in the document) |
|---|---|---|
| SPECT Detector Specifications (NEMA NU-1 Standards) | ||
| Intrinsic spatial resolution (Tc99m) - FWHM in CFOV | ≤3.84 mm | ≤3.84 mm |
| Intrinsic spatial resolution (Tc99m) - FWHM in UFOV | ≤3.94 mm | ≤3.94 mm |
| Intrinsic spatial resolution (Tc99m) - FWTM in CFOV | ≤7.54 mm | ≤7.54 mm |
| Intrinsic spatial resolution (Tc99m) - FWTM in UFOV | ≤7.74 mm | ≤7.74 mm |
| Intrinsic spatial linearity (Tc99m) - Differential in CFOV | ≤0.24 mm | ≤0.24 mm |
| Intrinsic spatial linearity (Tc99m) - Differential in UFOV | ≤0.24 mm | ≤0.24 mm |
| Intrinsic spatial linearity (Tc99m) - Absolute in CFOV | ≤0.44 mm | ≤0.44 mm |
| Intrinsic spatial linearity (Tc99m) - Absolute in UFOV | ≤0.7 mm | ≤0.7 mm |
| Intrinsic energy resolution (Tc99m) - FWHM in CFOV | ≤9.9% | ≤9.9% |
| Intrinsic flood field uniformity (uncorrected) - Tc99m Differential in CFOV | ≤2.5% | ≤2.5% |
| Intrinsic flood field uniformity (uncorrected) - Tc99m Differential in UFOV | ≤2.7% | ≤2.7% |
| Intrinsic flood field uniformity (uncorrected) - Tc99m Integral in CFOV | ≤2.9% | ≤2.9% |
| Intrinsic flood field uniformity (uncorrected) - Tc99m Integral in UFOV | ≤3.7% | ≤3.7% |
| CT Subsystem Performance (Bench Testing) | Compliance with IEC 60601-2-44 and US regulations (21 CFR 1020.33) | "Bench testing performed on the CT subsystem is conducted in accordance with IEC 60601-2-44 and in accordance with US regulations including 21 CFR 1020.33, Computed Tomography (CT) equipment. This is unchanged from the commercially available SOMATOM go CT systems (K211373)." |
| Software Functionality | Functionality described in specifications are met. | "System and System Integration testing (validation) was carried out for all features of the project, and all planned test cases were executed." |
| Risk Mitigation | All identified risks adequately mitigated; individual and overall residual risks reduced as far as possible. | "The product Risk Management Team has reviewed and verified that all risks identified in the Symbia Pro.specta VA20A Product Risk Analysis has been adequately mitigated and the individual and overall residual risks are reduced as far as possible." |
| Cybersecurity | Specific cybersecurity controls to prevent unauthorized access, modification, misuse, or denial of use. | "The Symbia Pro.specta VA20A systems software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse or denial of use... controls are enabled to prevent the unauthorized use of information that is stored, accessed or transferred between the Symbia Pro.specta VA20A systems and external devices." |
| General Safety (Electrical, Mechanical, Radiation) | Compliance with IEC 60601-1 series and 21 CFR 1020.30 and 21 CFR 1020.33. | "Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards such as IEC 60601-1 series and 21 CFR 1020.30 and 21 CFR 1020.33 to minimize electrical, mechanical and radiation hazards." |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily describes engineering and software performance testing, not a clinical study on patient data for diagnostic accuracy.
- Sample Size: Not applicable in the context of patient data test sets for diagnostic accuracy. The testing described is component-level and system-level verification and validation. For instance, for SPECT detector specifications, the "sample size" would relate to the number of measurements taken on a phantom or test object. The document states, "All Performance testing met the predetermined acceptance values," implying these tests were conducted sufficiently.
- Data Provenance: Not applicable in the traditional sense of patient data. The testing is internal to Siemens, likely conducted in their labs or on their manufactured devices. The document does not specify country of origin for any "data" used, as it's not a clinical trial. The testing is prospective in the sense that it's performed on the newly developed device and its components to verify performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable in the context of this 510(k) submission. The "ground truth" for detector performance and software functionality is established by engineering specifications, validated test procedures, and physical measurements against known standards (e.g., NEMA NU-1 phantoms). There is no mention of human expert consensus for interpreting images for diagnostic performance, as this submission is for an imaging system update, maintaining the predicate's intended use and performance characteristics, rather than proposing a new AI diagnostic algorithm.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation of images requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document makes no mention of an MRMC study or any comparative effectiveness study with human readers, with or without AI assistance. The submission focuses on demonstrating the technical performance and safety of the updated integrated imaging system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is geared towards AI/CAD systems. While the device includes software updates, including "MI View&GO updates" which incorporate "MI Neurology, Auto Lung 3D and syngo.MBF" (which could imply some level of automated analysis or display), the document does not describe them as standalone diagnostic algorithms requiring a separate performance study. The software is an "acquisition, display and analysis package intended to aid the clinician." The focus is on the integrated hardware and software system maintaining its predicate's performance.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing described is based on:
- Physical Measurements against established standards: For SPECT, this is NEMA NU-1 phantoms and specifications. For CT, it involves compliance with IEC 60601-2-44 and 21 CFR 1020.33.
- Software Requirements/Specifications: For software functionality, the ground truth is whether the implemented features perform according to their design specifications.
- Risk Analysis Outcomes: The ground truth for safety is the successful mitigation of identified risks as per ISO 14971.
There is no mention of ground truth derived from expert consensus, pathology, or outcomes data, as this is demonstrating substantial equivalence of a general imaging system, not the diagnostic accuracy of a specific AI feature.
8. The Sample Size for the Training Set
Not applicable. The document does not describe the development or training of a specific AI/ML algorithm that would require a "training set" in the machine learning sense. The software updates are described as "incremental improvements" and additions of existing modules (like MI Neurology, Auto Lung 3D from K222172) rather than a newly trained AI model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no described training set for an AI/ML algorithm.
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