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The ClARTIC Move is a mobile X-ray system designed to provide of the anatomical structures of patients during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastrointestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures. The patient population may include pediatric patients.

The CIARTIC Move is a mobile fluoroscopy C-arm x-ray system designed for the surgical environment. CIARTIC Move provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The CIARTIC Move consists of two major components: A. The C-arm with an X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and lifted vertically, shifted to the side and moved forward/ backward by an operator. All axes are motorized. B. The monitor trolley provides image processing, review, and patient data entry. The monitor trolley supports an optional hardcopy printer and navigational equipment. The trolley is connected to a mains power outlet or an optional data network.

The provided text describes the Siemens CIARTIC Move (VB10) mobile X-ray system and its comparison to a predicate device, the Cios Spin (VA30). It focuses heavily on non-clinical performance testing and technical comparisons rather than a typical clinical study evaluating AI performance in a diagnostic context. Therefore, many of the requested points related to AI-specific study design (such as human reader improvement with AI assistance, type of ground truth for AI, training set details) are not directly applicable or explicitly detailed in the provided document, as the device itself is a medical imaging hardware system with software updates for enhanced functionality, not an AI diagnostic algorithm.

Based on the provided information, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document outlines an array of non-clinical tests and a limited clinical study to demonstrate that the CIARTIC Move (VB10) meets its performance and safety requirements. The "acceptance criteria" are implied by the successful completion of these tests ("Passed").

2. Sample size used for the test set and the data provenance:

• Test Set (Clinical Study): The document mentions a "cross-sectional two-arm, controlled, open-label, mono-center, exploratory study with human specimens (body donations)."
  • Sample Size: The exact number of human body donations used as the sample size for the clinical study is not specified in the provided document.
  • Data Provenance: "human body donations" were used "in order to avoid radiation exposure to living humans." The study was "mono-center," but the country of origin is not explicitly stated. Given Siemens Healthineers AG (Germany) as the manufacturing site and Siemens Medical Solutions USA, Inc. (USA) as the importer/distributor, the location could be either, or potentially another region where such body donation studies are conducted. The study design is prospective, as it's a planned evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the document. The clinical study was focused on comparing imaging time and other parameters (procedural times, number of images, DAP) rather than a diagnostic accuracy study requiring expert adjudication of images. The "ground truth" for time-saving would be direct measurements.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• An adjudication method specific to image interpretation or diagnostic findings is not applicable and therefore not mentioned, as the study primarily measured time-based and procedural metrics.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done for AI assistance. The provided document describes the device as an "Image-Intensified Fluoroscopic X-Ray System" with updated software and hardware features, not an AI-powered diagnostic tool. The clinical study aimed to compare the time efficiency of the new device (CIARTIC Move VB10) against a predicate device (Cios Spin VA30), not to assess human reader performance improvements with AI assistance. Therefore, no effect size related to AI improvement is stated.

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

• This question is not applicable as the document describes a hardware device (X-ray system) with integrated software for operational improvements, not a standalone AI algorithm for medical diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical tests, the "ground truth" was established by engineering specifications, direct measurements, and compliance with recognized industry standards. The tests checked if the system's new functionalities (e.g., movement, display, collision detection, FOV) performed as designed and met technical requirements.
• For the clinical study, the "ground truth" for the primary endpoint (intraoperative imaging time) was direct measurement of time in seconds during the procedures on human body donations. Other secondary endpoints like number of images and dose area product (DAP) would also be direct measurements from the system.

8. The sample size for the training set:

• This information is not applicable as the document is about a hardware device with software updates, not an AI algorithm that undergoes a distinct "training set" process from ground-truthed clinical data. Software development and testing (functional, verification, system validation) are mentioned, which incorporate internal test data, but not a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

• This information is not applicable for the same reason as point 8. The software verification and validation are described as being based on "engineering requirements specifications," "subsystem requirements specifications," and "risk management hazard keys," with test results successfully traced to these.

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