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510(k) Data Aggregation
(228 days)
The Siemens syngo. CT Myocardial Perfusion software package has been designed to evaluate perfusion of the myocardium.
The software can calculate blood flow, blood volume, and other hemodynamic parameters from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.
It supports evaluation of regions of interest and the visual inspection of time attenuation curves.
syngo.CT Myocardial Perfusion is post-processing image analysis software that offers the quantitative analysis of dynamic CT data of the myocardium following the injection of contrast media. By providing information about myocardial blood flow and myocardial blood volume, syngo.CT Myocardial Perfusion allows the evaluation of potential perfusion disturbances in the myocardium due to coronary artery disease. This might aid in the assessment of the hemodynamic relevance of coronary stenosis
syngo.CT Myocardial Perfusion provides a fast simultaneous multi-slice calculation of the following perfusion parameter images:
- Myocardial blood flow (MBF) image .
- Myocardial blood volume (MBV) image ●
- Flow Extraction Product (FE) image ●
- Perfused Capillary Blood Volume (PCBV) image ●
- Extravascular Extracellular Volume (EEV) image
- Time to Peak (TTP) image ●
- Time to Start (TTS) image ●
- Tissue Transit Time (TTT) image ●
- Myocardial Blood Flow Corrected (MBFC) image; this parameter . map is a copy of the Myocardial blood flow (MBF) image
This premarket notification (K150713) for syngo.CT Myocardial Perfusion states that it is a post-processing image analysis software that offers quantitative analysis of dynamic CT data of the myocardium following contrast media injection. It calculates myocardial blood flow (MBF), myocardial blood volume (MBV), and other hemodynamic parameters to evaluate perfusion disturbances caused by coronary artery disease.
The device is considered substantially equivalent to the predicate device, syngo® Volume Perfusion CT Body (K092013). The modifications made to the predicate include:
- Separation of the Myocardial Perfusion algorithm into a stand-alone software application.
- Migration to the syngo.via client-server software platform.
- Updated Graphical User Interface (GUI).
- Additional option to store image results as Enhanced CT.
- Parallel display of several time attenuation curves (TAC).
- A modified Indication for Use specific to Myocardial Perfusion.
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that "the test results show that all of the software specifications have met the acceptance criteria." However, it does not provide a quantitative table of specific acceptance criteria values and corresponding device performance metrics. Instead, it relies on general statements about verification and validation testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Specifications Conformance | "The test results show that all of the software specifications have met the acceptance criteria." |
| Verification and Validation Testing | "Nonclinical tests were conducted for syngo.CT Myocardial Perfusion during product development. The modifications described in this premarket notification are supported with verification and validation testing. Results of this verification and validation testing were found acceptable to support the claim of substantial equivalence." |
| "Integration and functional tests were conducted... The test results show that all of the software specifications have met the acceptance criteria." | |
| Supportive Articles/Clinical Utility | "Supportive articles that demonstrate the usability of syngo.CT Myocardial Perfusion were provided to support device performance and functionality." (No specific metrics or studies are detailed in the provided text for these articles.) |
| General Safety and Effectiveness | "The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device." |
| "Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing." | |
| Substantial Equivalence (Non-clinical) | "The subject device non-clinical data supports the safety of the software with verification and validation testing. Verification and validation testing demonstrates that syngo.CT Myocardial Perfusion performs as intended. The non-clinical test data demonstrates that syngo.CT Myocardial Perfusion device performance is comparable to the predicate device that is currently marketed for the same intended use." |
| DICOM Conformance | Claims conformance to PS 3.1 – 3.18 (03/16/2012) |
| Software Life Cycle Processes | Claims conformance to IEC 62304 First edition 2006-05 |
| Risk Management | Claims conformance to ISO 14971 Second Edition 2007-03-01 |
| Usability | Claims conformance to IEC 60601-1-6 Edition 3.0 2010-01 |
| Programmable Electrical Medical Systems | Claims conformance to IEC 60601-1-4:2000, Consol. Ed. 1.1 |
| Cybersecurity | "Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "verification and validation testing" and "integration and functional tests." However, it does not specify the sample size (number of cases or images) used for these test sets. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions that the device uses scans from Siemens SOMATOM Definition Flash and SOMATOM Force scanners and was tested with both normal perfusion data (non-shuttle mode) and shuttle mode data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used to establish ground truth for any test set or their specific qualifications. The regulatory submission primarily focuses on the technical verification and validation of the software itself rather than clinical validation with expert-derived ground truth.
4. Adjudication Method for the Test Set:
No information regarding an adjudication method (such as 2+1 or 3+1) is provided in the document for any test set. The submission focuses on software testing against its specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
The document does not mention any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size for human readers improving with or without AI assistance. This type of clinical study is not detailed in this 510(k) submission, which primarily focuses on substantial equivalence based on technical and performance characteristics comparison to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The document states, "syngo.CT Myocardial Perfusion is post-processing image analysis software that offers the quantitative analysis of dynamic CT data..." and "As syngo.CT Myocardial Perfusion is a post processing application only..." This suggests that the core functionality of generating perfusion maps and parameters is performed by the algorithm in a standalone manner. The "performance tests were conducted to test the functionality of the subject device, syngo.CT Myocardial Perfusion," which would generally refer to testing the algorithm's output against expected results or specifications. However, specific details of a standalone performance study with quantitative metrics are not provided beyond the general statement of "verification and validation testing."
7. The Type of Ground Truth Used:
The document does not explicitly describe the type of ground truth used for any performance evaluation. Given the nature of a 510(k) for post-processing software, the "ground truth" for the verification and validation (V&V) testing would typically refer to:
- Known input-output relationships: Testing if the software accurately calculates parameters based on defined algorithms and synthetic or well-characterized real data where the expected output is known.
- Comparison to predicate device results: Ensuring the new software produces comparable results to the legally marketed predicate device for similar input data.
- Scientific literature/published models: Conformance to established scientific models for perfusion calculation.
No mention of expert consensus, pathology, or outcomes data being used as ground truth is present in the provided text.
8. The Sample Size for the Training Set:
The document does not provide any information regarding a training set sample size. As a post-processing software application, syngo.CT Myocardial Perfusion is described as utilizing deconvolution and Tofts' models for parameter calculation. This implies that the software is based on established mathematical models and algorithms, rather than a machine learning model that would require a distinct "training set" in the conventional sense. The development likely involved algorithmic optimization and software engineering rather than deep learning model training.
9. How the Ground Truth for the Training Set Was Established:
Since the document does not indicate the use of a "training set" for a machine learning model, it also does not describe how ground truth for such a set was established. The software's underlying algorithms (deconvolution, Tofts' model) are likely validated through theoretical correctness and empirical testing against known physical models or data with pre-calculated expected outputs.
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(146 days)
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis.
The SOMATOM Force is a whole body X-ray Computed Tomography System which features two continuously rotating tube-detector systems and functions according to the fan beam principle. The SOMATOM Force produces CT images in DICOM format, which can be used by postprocessing applications commercially distributed by Siemens and other vendors.
The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
The computer system delivered with the CT scanner is able to run the post processing applications optionally.
The Siemens SOMATOM Force is a whole-body X-ray Computed Tomography System.
1. Acceptance Criteria and Device Performance:
The provided document does not contain a specific table of acceptance criteria with corresponding device performance metrics for diagnostic accuracy or clinical effectiveness. Instead, the submission focuses on demonstrating safety, technical equivalence, and compliance with recognized standards.
The acceptance criteria for the SOMATOM Force appear to be primarily based on conformance to established safety and performance standards and substantial equivalence to a legally marketed predicate device (SOMATOM Definition Flash). The performance is assessed through nonclinical testing (integration and functional), phantom testing, and verification/validation testing.
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| Safety | Adherence to IEC and other recognized safety standards (e.g., electrical, mechanical, radiation hazards). | Fulfilled requirements of listed safety standards (e.g., IEC 60601 series, ISO 14971 for risk management). Risk analysis completed and controls implemented. EMC/electrical safety evaluated. |
| Performance/Functionality | Generation and processing of cross-sectional images; computer reconstruction of X-ray transmission data. Image quality. | Nonclinical tests (integration and functional) and phantom testing conducted. IBHC feature designed to improve image quality. |
| Substantial Equivalence | Comparable indications for use, design, material, functionality, technology, and energy source to the predicate device. | Considered substantially equivalent to SOMATOM Definition Flash (K121072). Intended use, materials, energy source, and fundamental scientific technology are similar. |
| Software Integrity | Conformance with special controls for medical devices containing software; all software specifications meet acceptance criteria. | Performance data submitted for special controls. Software verification and validation found acceptable. Software documentation for a moderate level of concern included. |
| Risk Management | Identification and mitigation of potential hazards. | Risk analysis completed, and risk controls implemented. Testing results support mitigation of identified hazards. |
2. Sample Size for Test Set and Data Provenance:
The document does not specify a "test set" in the context of clinical images or patient data for validating diagnostic performance. The testing described is primarily technical and phantom-based.
- Sample Size for Test Set: Not applicable in the context of diagnostic accuracy assessment with patient data in this submission. The tests mentioned are "nonclinical tests (integration and functional) and phantom testing."
- Data Provenance: Not applicable in the context of patient data. The nonclinical tests would have been performed by Siemens as part of product development.
3. Number of Experts for Ground Truth and Qualifications:
Not applicable. This submission focuses on the technical safety and performance of the CT scanner itself, not on the diagnostic performance of a software algorithm requiring expert ground truth for interpretation of patient images.
4. Adjudication Method:
Not applicable, as no external expert independent review of diagnostic performance with patient images is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned in the provided document. The submission focuses on the technical capabilities and safety of the CT scanner, not on comparing diagnostic accuracy with or without AI assistance.
6. Standalone (Algorithm Only) Performance:
Not applicable. The SOMATOM Force is a physical CT scanner, not a standalone algorithm. The "Iterative Beam Hardening Correction (IBHC)" is a feature within the system to improve image quality, not a separate diagnostic algorithm.
7. Type of Ground Truth Used:
For the evaluation described:
- Technical Performance: Likely based on physical phantom measurements, engineering specifications, and established scientific principles for image quality metrics (e.g., resolution, noise, contrast).
- Safety Compliance: Based on compliance with international and national safety standards (e.g., IEC standards for electrical safety, radiation protection, and medical device software).
- Substantial Equivalence: Based on comparison of technical characteristics and intended use with a legally marketed predicate device.
8. Sample Size for the Training Set:
Not applicable. The SOMATOM Force is a hardware system with integrated software for image acquisition and reconstruction. It is not an AI/ML-based diagnostic algorithm that undergoes a distinct "training phase" on a dataset in the manner described for typical AI submissions. The IBHC feature is a predefined algorithm rather than a continuously learning system.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there isn't a "training set" in the context of a machine learning model for diagnostic interpretation. The algorithms (like IBHC) are developed based on physics principles and engineering.
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