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The syngo.CT Bone Reading is image analysis software for CT volume data sets which has been continuously acquired with computed tomography (CT) imaging systems. The software combines following digital image processing and visualization tools:

• multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)
• geometric measurement tools (distance line, polyline, marker, arrow, angle)
• HU measurement tools (Pixel lens, ROI circle, ROI polygonal, ROI freehand, VOI sphere)
• curved MPR visualization (unfolded ribs and spine views), cross-section MPRs
• tools for creation and editing of anatomical centerline paths
• tools for creation and editing of anatomical labels

The specific visualizations of spine and rib structures allow for easy manual identification and marking of pathologies such as bone lesions or fractures. Reporting and documentation of results is facilitated by using of appropriate reporting tool, statistics and creation of ranges and snapshots.

syngo.CT Bone Reading is image analysis software for CT volume data sets which has been continuously acquired with computed tomography (CT) imaging systems.

syngo.CT Bone Reading combines basic and advanced digital image processing and visualization tools for easy manual identification, marking and reporting of pathologies such as bone lesions or fractures.

The software combines following digital image processing and visualization tools:

• multiplanar reconstruction (MPR) thin/thick, maximum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)
• geometric measurement tools (distance line, polyline, marker, arrow, angle)
• HU measurement tools (Pixel lens, ROI circle, ROI polygonal, ROI freehand, VOI sphere)
• curved MPR visualization (unfolded ribs and spine views), cross-section MPRs
• tools for creation and editing of anatomical centerline paths
• tools for creation and editing of anatomical labels

Reporting and documentation of results is facilitated by using of appropriate reporting tool, statistics and creation of ranges and snapshots.

Thereby, the user is always free to decide when or whether to apply particular tools. Accordingly, the user can operate the application in basic reading mode only and use conventional navigation on 2D and 3D views. Furthermore, during the whole reading process, the reading clinician has full control on the reported measurements, text and images.

The provided 510(k) submission for syngo.CT Bone Reading does not contain acceptance criteria or detailed results from a study proving the device meets said criteria in a manner that allows for a direct comparison table.

The submission focuses heavily on establishing substantial equivalence to predicate devices based on functional similarity and adherence to general medical device standards. It lacks specific performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be associated with acceptance criteria for a diagnostic aid that provides quantitative output or automated detection.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document states: "Non clinical tests were conducted for syngo.CT Bone reading software package during product development. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria." However, it does not specify what those acceptance criteria were or how the device performed against them.

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

Not available in the provided text. The document does not describe a clinical test set, its sample size, or its provenance (country of origin, retrospective/prospective).

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

Not available in the provided text. Since no specific clinical test set is described, there's no information on experts or ground truth establishment for such a set.

4. Adjudication Method for the Test Set

Not available in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size

Not available in the provided text. The submission focuses on the device's tools for manual identification and marking of pathologies, rather than automated detection or assistance that would be evaluated in a comparative effectiveness study.

6. Standalone Performance Study (Algorithm Only)

Not available in the provided text. The device is described as "image analysis software for CT volume data sets which has been continuously acquired with computed tomography (CT) imaging systems." It provides tools for manual identification and marking, implying human interaction is central to its intended use, rather than standalone algorithm performance.

7. Type of Ground Truth Used

Not available in the provided text for any specific performance claims. The document mentions "manual identification and marking of pathologies such as bone lesions or fractures" but doesn't define how ground truth for these pathologies would be established in a formal validation study for the software itself.

8. Sample Size for the Training Set

Not available in the provided text. The submission describes the software's functionality and its comparison to predicate devices, but does not discuss machine learning models, training data, or training set sizes.

9. How Ground Truth for the Training Set Was Established

Not available in the provided text. As no training set or machine learning components are discussed, this information is absent.

Summary of the Study (Based on Provided Text):

The submission describes "Non clinical tests were conducted for syngo.CT Bone reading software package during product development." These tests aimed to ensure the software met its specifications and that risk control measures were implemented. The testing "supports that all the software specifications have met the acceptance criteria" and "verification and validation of the device was found acceptable to support the claims of substantial equivalence."

However, this is a general statement about software development and testing, not a detailed report of a clinical performance study with specific acceptance criteria and results. The 510(k) strategy for syngo.CT Bone Reading appears to be based on demonstrating substantial equivalence through similar technological characteristics, indications for use, and safety/performance standards adherence to already cleared predicate devices, rather than through a novel clinical effectiveness study with quantitative performance metrics.

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