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The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT component produces cross-sectional images of the body by computer reconstruction of X-ray transmission data. The PET component images the distribution of PET radiopharmaceuticals in the patient body. The PET component utilizes CT images for attenuation correction and anatomical reference in the fused PET and CT images.

This device is to be used by a trained health care professional to gather metabolic and functional information from the distribution of the radiopharmaceutical in the body for the assessment of metabolic and physiologic functions. This information can assist in the evaluation, detection, diagnosis, staging, restaging, follow-up, therapeutic planning and therapeutic outcome assessment of (but not limited to) oncological, cardiovascular, neurological diseases and disorders. Additionally, this device can be operated independently as a whole body multi-slice CT scanner.

AiCE-i for PET is intended to improve image quality and reduce image noise for FDG whole body data by employing deep learning artificial neural network methods which can explore the statistical properties of PET data. The AiCE algorithm can be applied to improve image quality and denoising of PET images.

Deviceless PET Respiratory-gating system, for use with Cartesion Prime PET/CT system, is intended to automatically generate a gating signal from the list-mode PET data. The generated signal can be used to reconstruct motion corrected PET images affected by respiratory motion. In addition, a single motion corrected volume can automatically be generated. Resulting motion corrected PET images can be used to aid clinicians in detection, evaluation, diagnosis, staging, restaging, follow-up of diseases and disorders, radiotherapy planning, as well as their therapeutic planning, and therapeutic outcome assessment. Images of lesions in the thorax, abdomen and pelvis are mostly affected by respiratory motion. Deviceless PET Respiratory-gating system may be used with PET radiopharmaceuticals, in patients of all ages, with a wide range of sizes, body habitus, and extent/type of disease.

Cartesion Prime (PCD-1000A/3) V10.15 system combines a high-end CT and a high-throughput PET designed to acquire CT, PET and fusion images. The high-end CT system is a multi-slice helical CT scanner with a gantry aperture of 780 mm and a maximum scan field of view (FOV) of 700 mm. The high-throughput PET system has a digital PET detector utilizing SIPM sensors with temporal resolution of

This document describes the marketing authorization for the Cartesion Prime (PCD-1000A/3) V10.15 system, which combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT). The submission focuses on two new features: AiCE-i for PET and Deviceless PET Respiratory-gating system.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for AiCE-i for PET or the Deviceless PET Respiratory-gating system in a quantifiable manner (e.g., target SUV accuracy and achieved SUV accuracy).

However, for the Deviceless PET Respiratory-gating system, a qualitative assessment is provided.

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

• Deviceless PET Respiratory-gating system (Clinical Images Test Set): 10 patients.
• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It refers to "clinical images," which typically implies prospective data collection, but this is not explicitly confirmed.

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

• Number of Experts: Three physicians.
• Qualifications: "having at least 20 years of experience in nuclear medicine."

4. Adjudication Method for the Test Set

The document states: "All three physicians determined that all images were of diagnostic quality and images with deviceless had better or same performance as non-gated images or device-based gated images." This implies a consensus-based adjudication method, where all three experts had to agree on the diagnostic quality and comparative performance. It doesn't specify if a majority rule (e.g., 2+1) or an independent assessment followed by discussion was used, but the phrasing "All three physicians determined" suggests a unanimous agreement or a strong consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

Yes, a comparative effectiveness study involving human readers (the three physicians) was performed for the Deviceless PET Respiratory-gating system.

• Effect Size: The document qualitatively states that the deviceless system "had better or same performance as non-gated images or device-based gated images" and that "quantitative parameters such as accuracy of SUV (max and mean) and tumor volume, is improved over the current device-based gating method." However, no specific numerical effect size or statistical measure of improvement is provided (e.g., % improvement in SUV accuracy, statistically significant difference in diagnostic confidence scores).

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• AiCE-i for PET: The description of AiCE-i for PET implies a standalone algorithm's performance in improving image quality and denoising. However, no specific standalone study details (e.g., metrics, dataset) are provided in this summary.
• Deviceless PET Respiratory-gating system: Bench tests were conducted to demonstrate substantial equivalence and improvement in quantitative parameters (SUV max/mean, tumor volume) against device-based gating. This suggests an evaluation of the algorithm's output without direct human interpretation in that specific test phase, although the subsequent clinical image review involved human readers. Therefore, yes, a standalone performance evaluation for quantitative parameters was performed for the Deviceless PET Respiratory-gating system.

7. The Type of Ground Truth Used

• Deviceless PET Respiratory-gating system (Clinical Images Test Set): The ground truth for the clinical image review was based on expert consensus (the three physicians' determination of diagnostic quality and comparative performance). The statement regarding "accuracy of SUV (max and mean) and tumor volume" in bench testing implies the use of a quantitative ground truth, likely derived from established phantom measurements or gold-standard methodologies, though not explicitly detailed.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set for either AiCE-i for PET or the Deviceless PET Respiratory-gating system.

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

The document does not provide information on how the ground truth for the training set was established.

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