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Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.)

OrthoMatic Spine provides the means to perform musculoskeletal measurements of the whole spine, in particular spine curve angle measurements.

The TimeLens provides the means to compare a region of interest between multiple time points.

The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities.

An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, communication, and storage of medical images.

Syngo Carbon Clinicals is a software only Medical Device, which provides dedicated advanced imaging tools for diagnostic reading. These tools can be called up using standard interfaces any native/syngo based viewing applications (hosting applications) that is part of the SYNGO medical device portfolio. These tools help prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by medical imaging modalities (e.g., MR, CT etc.)

Deployment Scenario: Syngo Carbon Clinicals is a plug-in that can be added to any SYNGO based hosting applications (for example: Syngo Carbon Space, syngo.via etc…). The hosting application (native/syngo Platform-based software) is not described within this 510k submission. The hosting device decides which tools are used from Syngo Carbon Clinicals. The hosting device does not need to host all tools from the Syngo Carbon Clinicals, a desired subset of the provided tools can be used. The same can be enabled or disabled thru licenses.

When preparing the radiologist's reading workflow on a dedicated workplace or workstation, Syngo Carbon Clinicals can be called to generate additional results or renderings according to the user needs using the tools available.

This document describes performance evaluation for two specific tools within Syngo Carbon Clinicals (VA41): OrthoMatic Spine and TimeLens.

1. Table of Acceptance Criteria and Reported Device Performance

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

• OrthoMatic Spine:

  • Test Set Sample Size: 150 spine X-ray images (75 frontal views, 75 lateral views) were used in a reader study.
  • Data Provenance: The document states that the main dataset for training includes data from USA, Germany, Ukraine, Austria, and Canada. While this specifies the training data provenance, the provenance of the specific 150 images used for the reader study (test set) is not explicitly segregated or stated here. The study involved US board-certified radiologists, implying the test set images are relevant to US clinical practice.
  • Retrospective/Prospective: Not explicitly stated, but the description of "collected" images and patients with various spinal conditions suggests a retrospective collection of existing exams.

• TimeLens: No specific test set details are provided as a reader study/bench test was not required.

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

• OrthoMatic Spine:

  • Number of Experts: Five US board-certified radiologists.
  • Qualifications: US board-certified radiologists. No specific years of experience are mentioned.
  • Ground Truth for Reader Study: The "mean values obtained from the radiologists' assessments" for the 150 spine X-ray images served as the reference for comparison against the algorithm's output.

• TimeLens: Not applicable, as no reader study was conducted.

4. Adjudication Method for the Test Set

• OrthoMatic Spine: The algorithm's output was assessed against the mean values obtained from the five radiologists' assessments. This implies a form of consensus or average from multiple readers rather than a strict 2+1 or 3+1 adjudication.
• TimeLens: Not applicable.

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

• OrthoMatic Spine: A reader study was performed, which is a type of MRMC study. However, this was a standalone performance evaluation of the algorithm against human reader consensus, not a comparative effectiveness study with and without AI assistance for human readers. Therefore, there is no reported "effect size of how much human readers improve with AI vs without AI assistance." The study aimed to show the algorithm replicates average human rater performance.
• TimeLens: Not applicable.

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

• OrthoMatic Spine: Yes, a standalone performance evaluation of the OrthoMatic Spine algorithm (without human-in-the-loop assistance) was conducted. The algorithm's measurements were compared against the mean values derived from five human radiologists.
• TimeLens: The description suggests the TimeLens tool itself is a "simple workflow enhancement algorithm" and its performance was evaluated through non-clinical verification and validation activities rather than a specific standalone clinical study with an AI algorithm providing measurements.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• OrthoMatic Spine:
  • For the reader study (test set performance evaluation): Expert consensus (mean of five US board-certified radiologists' measurements) was used to assess the algorithm's performance.
  • For the training set: The initial annotations were performed by trained non-radiologists and then reviewed by board-certified radiologists. This can be considered a form of expert-verified annotation.
• TimeLens: Not specified, as no clinical ground truth assessment was required.

8. The Sample Size for the Training Set

• OrthoMatic Spine:
  • Number of Individual Patients (Training Data): 6,135 unique patients.
  • Number of Images (Training Data): A total of 23,464 images were collected within the entire dataset, which was split 60% for training, 20% for validation, and 20% for model selection. Therefore, the training set would comprise approximately 60% of both the patient count and image count. So, roughly 3,681 patients and 14,078 images.
• TimeLens: Not specified.

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

• OrthoMatic Spine: Most images in the dataset (used for training, validation, and model selection) were annotated using a dedicated annotation tool (Darwin, V7 Labs) by a US-based medical data labeling company (Cogito Tech LLC). Initial annotations were performed by trained non-radiologists and subsequently reviewed by board-certified radiologists. This process was guided by written guidelines and automated workflows to ensure quality and consistency, with annotations including vertebral landmarks and key vertebrae (C7, L1, S1).
• TimeLens: Not specified.

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The Siemens Symbia series is intended for use 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.

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, whole body 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 syngo MI Applications software is a 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.

The following statement applies only to Siemens Symbia Intevo 16, and Symbia Intevo Bold systems:

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 systems consist of Single Photon Emission Computed Tomography (SPECT) scanners and integrated hybrid X-Ray Computed Tomography (CT) and SPECT scanners. 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.

The provided text, K241898, describes a 510(k) premarket notification for Siemens Healthineers' Symbia SPECT and SPECT/CT Systems (Symbia VB23), which are updates to existing devices. The submission indicates that there are no significant changes to the fundamental technology or indications for use compared to the predicate device (Symbia 6.7 (VB22), K200474). Therefore, the provided text does not contain information about a study that proves the device meets specific acceptance criteria based on clinical performance metrics like sensitivity, specificity, or reader improvement.

Instead, the submission focuses on demonstrating substantial equivalence by highlighting that the core performance specifications of the SPECT detector and CT subsystem remain unchanged from the predicate device and that the updated system continues to comply with relevant safety and performance standards.

Here's an analysis of the information available in the document and a clear statement of what is not present regarding device performance studies:

What is present in the document:

• Acceptance Criteria (Implied / Compliance-based) and Reported Performance: The acceptance criteria are primarily implied through adherence to performance standards and regulations.
  • CT Subsystem Performance: "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. Each CT subsystem is tested and passes the Applicable Performance Standards prior to shipment." These standards include various parts of 21 CFR 1020.30, 21 CFR 1020.33, 21 CFR 1040.10, and 21 CFR 1040.11.
  • SPECT Detector and Collimator Performance: "Collimator performance testing is conducted according to NEMA NU-1:2018. All Performance testing met the predetermined acceptance values." The "Detector Specifications" (Figure 2) and "Quantitative Accuracy Specifications" (Figure 3) list specific numerical values for intrinsic spatial resolution, energy resolution, flood field uniformity, count rate performance, system spatial resolution, system planar sensitivity, and quantitative error. These serve as the quantitative acceptance criteria for the SPECT component, and the document states: "The quantitative error for all isotopes with the collimators is smaller or equal to 10%, and met the predefined acceptance criteria."
  • Software Validation: "Verification and validation of Siemens software is performed in accordance with documented procedures, test plans and specifications." This ensures functionality and quality.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Information NOT present in the document regarding a clinical performance study (e.g., for an AI/CAD algorithm):

The document does not describe a clinical study in the typical sense of evaluating the device's diagnostic performance (e.g., sensitivity, specificity, accuracy) using patient data with established ground truth. This is because the submission is for an updated version of an imaging system, not an AI/CAD software that provides diagnostic interpretations. The "syngo MI Applications software" is described as a "display and analysis package intended to aid the clinician," not as a tool that provides automated diagnostic outputs.

Therefore, the following points remain unaswered by the provided text:

1. Sample size used for the test set and the data provenance: Not applicable as no clinical test set for diagnostic performance evaluation is mentioned. The performance testing described is likely phantom-based or engineering-level.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for the system's physical performance is established by NEMA standards and engineering measurements, not clinical expert consensus.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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: Not applicable, as this device itself is not an AI/CAD system for diagnostic assistance, but an imaging scanner.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance testing cited (NEMA, CFR standards), the ground truth is established by the known physical properties of phantoms and calibrated measurement devices, ensuring the system outputs accurate measurements as per its specifications.
7. The sample size for the training set: Not applicable. This is an imaging system, not a machine learning algorithm requiring a training set in the typical sense. Software "verification and validation" is mentioned to ensure functionality, which refers to standard software development lifecycle testing, not ML model training.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a 510(k) submission for a SPECT/CT imaging system update, focusing on demonstrating substantial equivalence to an existing predicate device and compliance with established performance standards and regulations rather than presenting a clinical performance study of a diagnostic AI algorithm.

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The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric. Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, transesophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The AcuNav Catheter is intended for intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediative patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The Quantitative Ultrasound (OUS) software provides the ability to measure the attenuation coefficient in dB/cm-MHz at 3 MHz and the backscatter coefficient in dB/cm-str at 3 MHz in a 3-cm region of interest in the liver. Quantitative Ultrasound also includes the Ultrasonically-Derived Fat Fraction (UDFF) software which provides a 3-cm by 3-cm region of interest measurement tool to report an index that can be useful as an aid to the physician in managing adult patients with hepatic steatosis.

The ACUSON S2000, S3000 Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

All of the transducers and the catheter based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a) and remain unchanged from the currently cleared ACUSON S-Family systems (K172162).

Only the VTQ application has been modified, all other hardware and software features of the Diagnostic Ultrasound device remain unchanged. Only the ACUSON S2000 and S3000 systems will be updated with the software update to VE11A upon customer purchase of the Quantitative Ultrasound (QUS) application, which will be license controlled. The S1000 system does not support the VTQ application, therefore, will not be configured to support the QUS application.

The ACUSON S3000, S2000 Diagnostic Ultrasound System includes Quantitative Ultrasound (QUS) software that provides the ability to measure the attenuation coefficient (AC) and backscatter coefficient (BSC) at 3 MHz in a 3-cm region of interest in the liver. It also includes Ultrasonically-Derived Fat Fraction (UDFF) software for a 3-cm by 3-cm region of interest measurement that can aid in managing adult patients with hepatic steatosis.

Acceptance Criteria and Device Performance:

The provided document does not explicitly list numerical acceptance criteria for the QUS features (AC, BSC, UDFF) but describes their performance. The acceptance criteria for the QUS functionality appear to be demonstrated by its correlation with established methods and its intended clinical utility.

Study Details:

1. Sample Size and Data Provenance for Test Set:

   • Clinical Study Test Set: 101 participants.
   • Data Provenance: The document doesn't explicitly state the country of origin but refers to an "external clinical study." It is a prospective study as it involved acquiring acoustic property measurements from participants.
   • Phantom Study Test Set: Phantoms with known attenuation and backscatter coefficients. The number of phantoms or measurements is not specified.

2. Number of Experts and Qualifications for Ground Truth:

   • The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study.
   • For the UDFF index, the ground truth reference was MRI Proton Density Fat Fraction (MRI-PDFF), an objective imaging biomarker.
   • For steatosis grading (0, 1, 2, 3), it refers to "% hepatocytes," implying histological assessment, which is typically done by pathologists. No specific number or qualifications are given.

3. Adjudication Method for Test Set:

   • The document does not describe an adjudication method for the test set. For the UDFF index, it relies on a "least squares fit" to MRI-PDFF. For steatosis grades, it appears to rely on histological assessment without mentioning a specific adjudication process among experts.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study is mentioned for the QUS features (AC, BSC, UDFF). The study focuses on the standalone performance and correlation with reference methods.

5. Standalone Performance Study:

   • Yes, a standalone study was performed. The QUS software, including AC, BSC, and UDFF measurements, was evaluated independently.
   • The phantom study assessed the accuracy and precision of AC and BSC measurements.
   • The clinical study assessed the acoustic property measurements (AC and BSC) and the derived UDFF index in relation to MRI-PDFF and histological steatosis grades.

6. Type of Ground Truth Used:

   • Phantom Study: Known nominal values of attenuation and backscatter coefficients.
   • Clinical Study for UDFF: MRI Proton Density Fat Fraction (MRI-PDFF %) measurements were used as the reference standard to establish the UDFF index via a least squares fit.
   • Clinical Study for Steatosis Grading: Histological assessment (percentage of hepatocytes) was used to define steatosis grades (S0, S1, S2, S3), which were then correlated with UDFF and MRI-PDFF values.

7. Sample Size for Training Set:

   • The document does not explicitly specify a separate training set size for the QUS software. The clinical study with 101 participants appears to be used for the development and evaluation of the UDFF index, which is based on a "least squares fit" to MRI-PDFF measurements. This suggests the clinical data was used to train/calibrate the UDFF algorithm.

8. How Ground Truth for Training Set Was Established:

   • Assuming the clinical study data (101 participants) served as the primary data for establishing the UDFF index:
     • MRI-PDFF: This is an objective measurement obtained from magnetic resonance imaging.
     • Steatosis Grade: Defined by the percentage of hepatocytes, which is determined through histological examination (pathology).

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