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The Supria system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes.

The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA). Multi-planar reconstruction (MPR) and volume rendering.

Volume datasets acquired by the Supria can be transferred to external devices via a DICOM standard interface. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.

The SUPRIA is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 16-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.

The SUPRIA system uses 16-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 16 slices of data simultaneously. The X-rav sub-system features a high frequency generator. X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles.

The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.

The SUPRIA system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets those criteria with numerical performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device (SCENARIA Phase 2 Whole-body X-ray CT System K123509) through comparison of technological characteristics and general performance.

Here's an attempt to extract and synthesize the requested information based on what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria. Instead, it relies on demonstrating that the SUPRIA w/guideShot Option has "equivalent basic performance" or "comparable performance" to the predicate device, SCENARIA Phase 2. The 'Performance' section within the "Device Technological Characteristics" table offers some numerical comparisons for specific aspects:

Note: The "Acceptance Criteria" column is inferred from the predicate device's specifications, as the goal is to show equivalence. The "Reported Device Performance" column directly reflects the SUPRIA's specifications as listed. The document states that the SUPRIA's performance characteristics are "comparable" or "generally equivalent" to the predicate, and for some specific metrics like reconstruction time, SUPRIA even shows improved performance.

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

• Test Set Sample Size: The document mentions that "clinical images were collected and analyzed" and that "clinical image examples" were provided. However, it does not specify a numerical sample size for this clinical image collection.
• Data Provenance: Not explicitly stated. The document simply refers to "clinical images." It does not mention the country of origin or whether the data was retrospective or prospective.

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

The document states, "We provide clinical image examples which we judged to be sufficient to judge a clinical usability." This implies an internal assessment.

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It only mentions "we judged," which could refer to the manufacturer's internal team.

4. Adjudication Method for the Test Set

Not specified. The document only mentions that "clinical images were collected and analyzed" and "judged to be sufficient to judge a clinical usability." There is no indication of a formal adjudication process (e.g., 2+1, 3+1).

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

• Was an MRMC study done? No, the document does not indicate that an MRMC comparative effectiveness study was conducted. The evaluation focuses on the device's technical specifications and a comparison to a predicate device, rather than human reader performance with and without AI assistance.
• Effect size of human readers with AI vs. without AI assistance: Not applicable, as no MRMC study involving AI assistance for human readers was reported.

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

The device itself is a Computed Tomography (CT) system (hardware and software for image acquisition and basic post-processing), not an AI algorithm for diagnosis. The "guideShot Option" adds remote in-room display and controls for interventional imaging. Therefore, the concept of a "standalone algorithm" performance as typically evaluated for AI-driven diagnostic tools is not directly applicable here. The focus is on the performance of the CT system in producing images, which are then used by a physician.

7. The Type of Ground Truth Used

The document mentions "clinical image examples" which were "judged to be sufficient to judge a clinical usability." This suggests the ground truth was based on:

• Expert Clinical Judgment/Usability: The images were evaluated to confirm they met clinical usability standards, likely by qualified personnel. It does not mention pathology, outcomes data, or a formal consensus process as a "ground truth" for diagnostic accuracy of an AI model within the system.

8. The Sample Size for the Training Set

Not applicable. The SUPRIA w/guideShot Option is a computed tomography x-ray system, not primarily an AI algorithm that undergoes "training" in the conventional sense of machine learning for image interpretation. The device's software includes image reconstruction and post-processing capabilities, which are based on established scientific principles and algorithms, not a training set of images with ground truth for learning.

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

Not applicable, as there is no mention of a training set or AI model training in the context of this device.

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