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CT TrueView assists physicians during cardio-vascular interventions when analyzing 2D images by segmenting a previously acquired 3D CT to create a 3D model of the coronary vessel tree.

CT TrueView supports the physician navigating a catheter or guide wire through the coronary arteries by providing a composite image that combines a 2D X-ray exposure image with a CT based 3D visualization of the heart and/or coronaries.

CT TrueView is suitable for use with the adult human population.

CT TrueView is a software medical device with the following characteristics:
The proposed CT TrueView is considered an accessory to the currently marketed Allura Xper FD series X-ray System (Philips Medical Systems Nederland B.V., K141979). It operates on the currently marketed Interventional Workspot (Philips Medical Systems Nederland B.V., K121296) software hosting platform. The proposed CT TrueView assists physicians during cardio-vascular interventions by providing a 3D model of the coronary vessel tree. The 3D model is created from a pre-acquired 3D CT dataset segmented by the user. The proposed CT TrueView supports the physician navigating a catheter or guide wire through the coronary arteries by providing a composite image that combines a 2D X-ray exposure with a CT based 3D visualization of the heart and/or coronaries. The proposed CT TrueView provides a range of viewing angles that result in an unobstructed and minimally foreshortened projection of a specific segment and/or bifurcation. The selected viewing angles are programmed automatically on the connected Allura Xper FD series X-ray system. The proposed CT TrueView includes measurement tools to estimate the length and diameter of a segment of the 3D model and to estimate the bifurcation angle of a bifurcated segment. The proposed CT TrueView provides a CTO Navigator feature that allows the user to combine a 2D X-ray image with the 3D model of the heart and/or coronaries in one composite image.

The Philips Medical Systems Nederland B.V. CT TrueView device (K160147) is a software medical device that assists physicians during cardio-vascular interventions by segmenting a pre-acquired 3D CT to create a 3D model of the coronary vessel tree. It supports navigation of catheters through coronary arteries by combining a 2D X-ray exposure with a CT-based 3D visualization.

Here's an analysis of its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not provide specific quantitative acceptance criteria or detailed reported device performance metrics in a tabular format as would typically be found in a clinical study report. Instead, it indicates that "all verification tests were executed successfully, showing that the requirements are met and hazard mitigations are implemented correctly" and that "the accuracy of the measurement tool is in line with its specification." For algorithm validation, it states that "the algorithms provide the user with correct information required to support the clinical procedure within the scope of the intended use of CT TrueView."

Since no specific numerical acceptance criteria were provided, a direct comparison table cannot be created. The document focuses on demonstrating compliance with standards and successful execution of internal validation activities.

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

• Test Set Sample Size: The document mentions two algorithm validation studies:
  • Orientation Mismatch: 3 different phantoms were used.
  • Optimal Projection: The sample size for this study is not explicitly stated in terms of patient data or number of cases. It only refers to validating the performance in determining optimal projections.
• Data Provenance: Not specified for the algorithm validation studies. For the "Orientation Mismatch" study, phantoms were used, indicating artificial data rather than patient data. For the "Optimal Projection" study, the provenance is not mentioned. The document does not specify country of origin or whether the data was retrospective or prospective for any testing.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for any of the non-clinical performance tests, including the algorithm validation studies.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating the test sets.

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

No multi-reader multi-case (MRMC) comparative effectiveness study was performed or referred to in the provided summary. The device's primary function is to assist physicians with visualization and guidance, rather than a diagnostic algorithm that would typically require MRMC studies. The document explicitly states: "The subject of this premarket submission, CT TrueView Rel. 2.0, did not require clinical studies to support substantial equivalence."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The algorithm validation studies primarily focus on the standalone performance of specific algorithms within the device (e.g., orientation mismatch, ability to determine optimal projection). These tests assess the technical accuracy and functionality of the algorithms themselves, largely independent of a human-in-the-loop setting, though the ultimate goal is to support clinician use.

7. Type of Ground Truth Used

• Orientation Mismatch Study: The ground truth would have been based on the known geometries and properties of the 3 phantoms used (coronary vessel tree, vessel with occlusion, vessel with stenosis). This implies a known physical model or synthetic ground truth.
• Optimal Projection Study: The type of ground truth used for validating the "optimal projection" performance is not explicitly stated. It would likely involve predefined "optimal" views based on established clinical understanding or expert consensus in relation to reducing foreshortening and overlap, but the details are missing.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size of a training set for the CT TrueView algorithms. Given that the device performs functions like segmentation and 3D modeling, it is implied that algorithms are involved, which would typically require training data. However, this information is not disclosed in the 510(k) summary.

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

As no information regarding a training set or its sample size is provided, there is no description of how ground truth for a training set was established.

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