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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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