Search Results

The Siemens Biograph 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 and Biograph mCT 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 Vision and Biograph mCT 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 and Biograph mCT 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 Biograph Vision and Biograph mCT systems, which are the subject of this application, is substantially equivalent to the commercially available Biograph Vision and Biograph mCT software.

• Somaris Software (cleared in K230421)
  • Upgrade to the latest revision of Somaris Software (Somaris/7 syngo CT VB30) with modified software features:
    • FAST Bolus
    • FAST 4D
    • FAST Applications (FAST Spine, FAST Planning)
    • Automatic Patient Instructions
    • Additional default exam protocols
    • Additional kV setting for Tin Filtration
• PETsyngo software
  • SMART Image Framer (available for Vision 600 and X models only – cleared in K223547)
• Updated computer hardware due to obsolescence issues (cleared in K230421). These changes do not affect system performance characteristics and have no impact on safety or effectiveness.

The Biograph Vision may also use the names Biograph Vision Quantum and Peak for marketing purposes.

Here's an analysis of the provided FDA 510(k) clearance letter for Siemens Biograph Vision and mCT PET/CT Systems, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the performance of the updated software (VG85) for the Siemens Biograph Vision and Biograph mCT PET/CT Systems, comparing it to the predicate device (VG80). The "Acceptance Criteria" for the subject device are explicitly stated as "Same" as the predicate device's performance values. This implies that the updated system must perform at least as well as the predicate device across all tested metrics.

Ask a specific question about this device

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 staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

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.

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10 for the following SOMATOM Computed Tomography (CT) Scanner Systems:

SOMATOM go. Platform CT scanner systems:

• . SOMATOM go.Up
• . SOMATOM go.Now
• SOMATOM go.All
• SOMATOM go.Top
• . SOMATOM go.Sim
• . SOMATOM go.Open Pro

SOMATOM X. Platform CT scanner systems:

• . SOMATOM X.cite
• . SOMATOM X.ceed

In this submission, the above listed CT scanner systems are jointly referred to as subject devices by "SOMATOM go. Platform" and "SOMATOM X. Platform" CT scanner systems.

The subject devices SOMATOM go. Platform and SOMATOM X. Platform with SOMARIS/10 syngo CT VB10 are Computed Tomography X-ray Systems which feature one continuously rotating tubedetector system and function according to the fan beam principle (single source). The SOMATOM go. Platform and SOMATOM X. Platform with software SOMARIS/10 syngo CT VB10 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.

Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.

The platform software for the SOMATOM go. Platform and SOMATOM X. Platform, SOMARIS/10 synqo CT VB10, is a command-based program used for patient management, data management, Xray scan control, image reconstruction, and image archive/evaluation.

The software platform provides plugin software interfaces that allow for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.

New software version syngo CT VB10 (SOMARIS/10 syngo CT VB10) is a modified software version based on syngo CT VA40 (SOMARIS/10 syngo CT VA40) which was cleared for the predicate device in K211373.

Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as an optional upgrade for the applicable existing SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems.

The bundle approach is feasible for this submission since the subject devices have similar technological characteristics, software operating platform, and supported software characteristics. The supporting data are similar, primarily one review division/group will be involved, and the indications for use is the same between the devices. All subject devices will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use remains unchanged compared to the predicate devices.

The provided text is a 510(k) summary for a Computed Tomography (CT) system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical testing and comparison of technological characteristics. The document does not contain information about comparative effectiveness studies, multi-reader multi-case (MRMC) studies, or detailed clinical study results with ground truth establishment as one might find for a novel AI/ML-driven diagnostic device.

Therefore, many of the requested items (e.g., sample size for the test set, number of experts, adjudication methods, MRMC study effect size, training set details) are not explicitly mentioned in this type of submission. The focus here is on the CT system itself and its software updates, not on a new AI algorithm for detection or diagnosis where such detailed performance metrics against ground truth would be paramount.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria & Reported Device Performance

The document describes "bench testing" as non-clinical supportive testing for specific features. The acceptance criteria are generally qualitative (e.g., "comparable accuracy," "reduce the number of alignment artefacts," "successfully detect needle-tips") rather than specific numerical thresholds.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for any of the individual feature tests. The tests refer to "phantom tests" and "analysis of phantom images". For "myNeedle Guide," it mentions "a wide variety of scans," but no specific number.
• Data Provenance: The document does not specify the country of origin for the test data (phantoms) or if any retrospective/prospective human data was used. Given the nature of these tests (bench testing on phantoms), human patient data is generally not the primary focus for these types of technical evaluations.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not provided as the testing primarily involves technical and phantom-based evaluations, not clinical reader studies requiring expert ground truth.

4. Adjudication Method for the Test Set

• This information is not applicable/provided as detailed clinical studies with reader adjudication are not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No, an MRMC comparative effectiveness study is not mentioned in this 510(k) summary. The submission focuses on demonstrating substantial equivalence through technical testing and feature comparison, not on quantifying improvement in human reader performance with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• For the "myNeedle Guide" feature, the 90.76% detection rate of needle tips might be considered a form of standalone performance for that specific algorithmic component, though it's still being evaluated in the context of aiding a human user. For other features, the tests are primarily system-level or component-level functional checks.

7. The Type of Ground Truth Used

• For the non-clinical tests described, the "ground truth" would be established through phantom specifications and controlled experimental setups with known parameters (e.g., precise needle location in a phantom, known artifact presence/absence in a reconstructed image). This is typical for engineering verification and validation testing for CT systems.
• For the "myNeedle Guide," the "ground truth" for needle tip detection would likely be based on the known, true location of the needle tip within the phantom or experimental setup.

8. The Sample Size for the Training Set

• This information is not provided. The document describes software updates and system features, not the development of a new AI model from a training set. If the "myNeedle Guide" used machine learning, its training set details are not described here.

9. How the Ground Truth for the Training Set was Established

• This information is not provided as no training sets are explicitly described.

Ask a specific question about this device

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 trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

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 subject device SOMATOM Pro.Pulse with software version SOMARIS/10 synqo CT VB10 is a Computed Tomography X-ray system which features two continuously rotating tube-detector system (dual source) and functions according to the fan beam principle. The SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 produces CT images in DICOM format. The images delivered by the system can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation, radiation therapy planning, and therapeutic interventions (including, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications.

The platform software for the SOMATOM Pro.Pulse is SOMARIS/10 syngo CT VB10. It is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The software platform provides plugin software interfaces that allow for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.

The provided text describes the Siemens SOMATOM Pro.Pulse CT system, its modifications, and its substantial equivalence to predicate devices, but it does not contain a detailed study proving the device meets specific acceptance criteria in the format requested. Instead, it refers to broad categories of non-clinical testing and general statements about meeting pre-determined acceptance criteria.

Here's an attempt to structure the answer based on the available information. Many fields will be marked as "Not Provided" due to the nature of the document being a 510(k) summary, which often focuses on establishing substantial equivalence rather than detailed study results for specific performance metrics.

Acceptance Criteria and Device Performance Study for SOMATOM Pro.Pulse

The K232206 submission for the SOMATOM Pro.Pulse focuses on demonstrating substantial equivalence to its predicate devices (SOMATOM go.Top (K211373) and SOMATOM Drive (K230421)). The document details non-clinical testing performed to verify and validate modifications and ensure the device's functionality, image quality, and safety are comparable to the predicates.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria alongside numerical performance results for the device. Instead, it offers qualitative descriptions of performance objectives and outcomes for various features based on bench testing.

2. No introduction of new artifacts by SAC reconstruction.
3. Equivalent image quality (noise, homogeneity, high-contrast resolution, slice thickness, CNR) in phantom-based measurements compared to standard reconstruction.
4. Equivalent image quality with metal objects compared to standard reconstruction.
5. Successful application of SAC algorithm to phantom data, demonstrating correct technical function and independence from physical detector width. | 1. "If misalignment artefacts are identified in non-corrected standard ECG-gated reconstructed sequence or spiral images, the feature "Cardiac Stack Artefact Correction" (SAC, marketing name: ZeeFree) enables optional stack artefact corrected images, which reduce the number of alignment artefacts."
6. "The SAC reconstruction does not introduce new artefacts, which were previously not present in the non-corrected standard reconstruction."
7. "The SAC reconstruction does realize equivalent image quality in quantitative standard physics phantom-based measurements (ACR, Gammex phantom) in terms of noise, homogeneity, high-contrast resolution, slice thickness and CNR compared to a non-corrected standard reconstruction."
8. "The SAC reconstruction does realize equivalent image quality in quantitative and qualitative phantom-based measurements with respect to metal objects compared to a non-corrected standard reconstruction."
9. "The SAC algorithm can be successfully applied to phantom data if derived from a suitable motion phantom demonstrating its correct technical function on the tested device. The SAC algorithm is independent from the physical detector width of the acquired data." |
   | Dual Source Dual Energy (DSDE) | Successful implementation of DSDE with 80 kV / Sn140 kV and 100 kV / Sn140 kV voltage combinations.
   Image quality and spectral properties (iodine ratio) comparable to the reference device (SOMATOM Drive).
   All applied image quality tests passed. | "The measurements show that the spectral characteristics of the system in terms of iodine ratio are well comparable to the reference device SOMATOM Drive. All applied tests concerning image quality passed." |
   | FAST 3D Camera/FAST Integrated Workflow | Accuracy of FAST Isocentering, FAST Range, and FAST Direction comparable to the predicate device with syngo CT VA40 (old camera hardware, ceiling mount). | "The FAST Isocentering accuracy of the subject device with syngo CT VB10 is comparable to the predicate device with syngo CT VA40, regardless of the camera mounting position."
   "For the FAST Range feature, the detection accuracy of all body region boundaries is comparable between the subject device with syngo CT VB10 and predicate device with syngo CT VA40."
   "The FAST Direction pose detection results are of comparable accuracy for subject and predicate device, regardless of the camera mounting position."
   "Overall, the SOMARIS/10 syngo CT VB10 delivers comparable accuracy to the SOMARIS/10 syngo CT VA40 predicate for the new FAST 3D Camera hardware, also in the new gantry position." |
   | myNeedle Guide (with myNeedle Detection) | 1. High accuracy of automatic needle detection algorithm.
10. Reduction of necessary user interactions for navigating to a needle-oriented view. | 1. "It has been shown that the algorithm was able to consistently detect needle-tips over a wide variety of scans in 90.76% of cases."
11. "Further, the results of this bench test clearly shows that the auto needle detection functionality reduces the number of interactions steps needed to generate a needle-aligned view in the CT Intervention SW. Zero user interactions are required and a needle-aligned view is displayed right away after a new scan, if auto needle detection is switched on in the SW configuration." |
    | CARE kV | Effective mAs settings of low and high kV acquisitions in TwinkV scan adapted by CARE kV to maintain image quality (CNR).
    Consistency of image qualities (CNR values) in certain phantoms under different kV settings in "Manual kV" mode.
    Consistency of contrast, noise, and CNR values in mix images for all voltage combinations. | "Using CARE kV for TwinkV, contrast, noise, and CNR values in the mix images are consistent for all voltage combinations. In all cases, CNR values do not deviate by more than 10% from the average CNR over the available voltage combinations." |
    | Flex 4D Spiral - Neuro/Body | No artifacts should be observed due to missing data, indicating correct trajectory functioning, even with pitch setting changes. | "No artifacts had been observed for any F4DS scan mode due to missing data, indicating that the trajectories work properly in hand. This also accounts for the scenario, where the user may change the pitch setting to get access to another range of scan coverages." |
    | Low-Dose Lung Cancer Screening | Technical parameters specific to Low-Dose Lung Cancer Screening comparable to predicate and subject devices. | "It can be concluded that the subject and predicate devices are substantially equivalent for the task of Low-Dose Lung Cancer Screening since the bench test results showed comparable technical parameters." |

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "phantom studies" and "phantom data" for several tests (ZeeFree, Dual Source Dual Energy, CARE kV, Flex 4D Spiral). For FAST 3D Camera, it tested the subject device against the predicate. For myNeedle Guide, it states the algorithm was able to consistently detect needle-tips in "90.76% of cases" over "a wide variety of scans." However,

• Specific sample sizes (N) for phantom studies or "a wide variety of scans" are not provided.
• Data Provenance (e.g., country of origin, retrospective/prospective) is not explicitly stated for these performance tests. Given they are "bench tests" and "phantom studies," they implicitly suggest a controlled laboratory setting (likely at the manufacturing locations in Germany or China) rather than clinical patient data. The reference to the National Lung Screening Trial (NLST) is supportive literature for the additional lung cancer screening Indications for Use, not a test set for the device's technical performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Provided. The non-clinical tests described in the document appear to be technical performance evaluations, primarily using phantoms and comparing against known technical specifications or established predicate device performance. There is no mention of experts establishing ground truth for these technical tests.

4. Adjudication Method for the Test Set

• Not Provided. This is typically relevant for studies involving human interpretation or clinical outcomes, which are not detailed for the device's technical performance validation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No, an MRMC comparative effectiveness study is not described for the SOMATOM Pro.Pulse's performance relative to its predicate devices. The document focuses on demonstrating comparable technical performance through non-clinical bench testing.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no MRMC study comparing human readers with and without AI assistance is detailed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

• Yes, the described "bench tests" and "phantom studies" are effectively standalone algorithm-only performance evaluations. For example, the ZeeFree reconstruction and myNeedle Detection algorithm evaluations are reported based on their intrinsic technical performance in a controlled setting without human intervention in the loop of image acquisition or primary interpretation for the purpose of the validation described.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be:

• Known phantom properties and measurements: For image quality metrics (noise, homogeneity, resolution, CNR, slice thickness).
• Known mechanical or digital parameters: For features like FAST 3D Camera (accuracy of Isocentering, Range, Direction) and Flex 4D Spiral (absence of artifacts due to missing data).
• Predicate device performance: Used as a reference for comparison, implying its performance is considered a benchmark or "ground truth" for equivalence.
• Quantifiable algorithm outputs: For myNeedle Detection, the algorithm's ability to consistently detect needle tips (90.76% accuracy).

8. The Sample Size for the Training Set

• Not Provided. The document describes bench testing for verification and validation, but it does not specify details about the training data used for any machine learning components (such as the optimization of the FAST 3D Camera algorithms or myNeedle Detection, if they involve machine learning).

9. How the Ground Truth for the Training Set Was Established

• Not Provided. Similar to the training set size, the method for establishing ground truth for any potential training data is not detailed in this submission summary.

Ask a specific question about this device