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The Spectral CT on Rails is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories. The Spectral CT on Rails system acquires one CT dataset – composed of data from a higher-energy detected x-ray spectrum and a lower- energy detected x-ray spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number.

This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology and in oncology.

The system is also intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*.

The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.

*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 proposed Spectral CT on Rails System is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The proposed Spectral CT on Rails System consists of three main components: a rotating gantry that slides on a carriage in the horizontal direction, stationary patient support and an operator console for scan control and image reconstruction. On the gantry, the main active components are the X-ray HV power supply, the X-ray tube and the detection system. The fundamental design and characteristics of the main components used in the proposed Spectral CT on Rails System, are identical to the cleared to market primary predicate device, Spectral CT System (K203020). The proposed Spectral CT on Rails System consists of main components that are similar to the cleared for market primary predicate device, Spectral CT (K203020) Gantry. The Gantry consists of the following main internal units: Stator - a fixed mechanical frame that carries HW and SW Rotor - A rotating circular stiff frame that is mounted in and supported by the stator. X-Ray Tube (XRT) and its power Generator, and the upper beam mechanism – fixed to the Rotor frame Rails - the rails system includes a carriage which the gantry sits on so that it may be moved back and forth on the rails horizontally relative to a stationary patient support that the patient lays on. The moving gantry functionality has previously been cleared in, Philips CT Big Bore Sliding Gantry Configuration (K181797), secondary predicate device. Data Measurement System (DMS) – a detectors array, fixed to the rotor in front of the XRT.

Console - A computer and display that interfaces between the system and the user. Common Image Reconstruction Unit (CIRS) – a dedicated powerful image reconstruction system

In addition to the above components and the operating software, the system includes: Workstation hardware and software for data acquisition and image display, manipulation, storage, and filming; as well as post-processing into views other than the original axial images. Spectral Reconstruction System Spectral CT Viewer.

Here's a breakdown of the acceptance criteria and study information for the Philips Medical Systems Nederland B.V. Spectral CT on Rails (K212875), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Spectral CT K203020) rather than listing explicit quantitative acceptance criteria for each image quality metric. Instead, the acceptance criterion for the Spectral CT on Rails is that its performance is "equivalent" to the predicate device.

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

• Sample Size for Anthropomorphic Phantom Image Review Testing: Not explicitly stated, but it involved "an anthropomorphic phantom" scanned on both the proposed device and the predicate device. It implies a single phantom, however, multiple "scans" were performed.
• Sample Size for Image Quality Performance Testing: Not explicitly stated, but involved "physics image quality test phantoms" scanned on both devices. It implies multiple phantoms covering different image quality metrics.
• Data Provenance: The data is generated internally by Philips through testing of their devices (proposed and predicate). It is not retrospective or prospective clinical data from patients but rather non-clinical phantom-based image quality data. The country of origin of the data is not specified beyond being Philips' internal testing.

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

• Anthropomorphic Phantom Image Review Testing: The review was performed to "determine if the two scanners produced comparable image quality." It does not specify the number or qualifications of experts involved in this review. It states "After the review of the clinical scenarios it was concluded..." This suggests a qualitative assessment by an unnamed reviewer(s).
• Image Quality Performance Testing: This involved quantitative measurements on physics phantoms. Ground truth is established by the known physical properties and measurement methods for metrics like CT number, uniformity, noise, spatial resolution, etc., rather than expert reader consensus. Therefore, no "experts" in the sense of radiologists establishing ground truth for clinical cases are mentioned for this type of test.

4. Adjudication Method for the Test Set:

• For the anthropomorphic phantom image review, the document simply states "Each scan was reviewed to determine if the two scanners produced comparable image quality" and "it was concluded that the image quality... was equivalent." No specific adjudication method (e.g., 2+1, 3+1) is mentioned.

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

• No MRMC comparative effectiveness study was done. The submission states: "The subject of this premarket submission, the proposed Spectral CT on Rails did not require clinical studies to support equivalence Clinical Performance Data." The studies performed were non-clinical image quality comparisons.

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

• The Spectral CT on Rails is a complete computed tomography x-ray system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" doesn't directly apply here in the way it would for an AI-powered diagnostic software. The device's performance, as a system, was evaluated.
• However, the image quality performance testing can be considered an objective, quantitative assessment of the system's output (images) without human interpretation influencing the primary metrics being measured (CT number, noise, spatial resolution, etc.). The anthropomorphic phantom review has a human qualitative component, but the quantitative image quality metrics are standalone.

7. The Type of Ground Truth Used:

• Phantom-based Ground Truth: For the "Image quality performance testing," the ground truth is established by the known physical characteristics of the test phantoms (e.g., Catphan phantom for low contrast resolution) and the objective physical measurements performed on the acquired images.
• Qualitative Comparison for Anthropomorphic Phantom: For the "Anthropomorphic phantom image review testing," the ground truth for "comparable image quality for typical clinical applications" is based on a qualitative review, implicitly against established expectations for CT image quality and the predicate device's performance.

8. The Sample Size for the Training Set:

• This submission describes a hardware and software system ("Spectral CT on Rails"), not an AI/Machine Learning model that requires a "training set" in the conventional sense. The "training" for such a system typically involves engineering design, development, and validation against specifications, not data-driven machine learning training. Therefore, no training set sample size is applicable or provided.

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

• As concluded in point 8, this question is not applicable as there is no "training set" for an AI/ML model described in this submission for this device.

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