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

The Siemens Cios Fusion mobile fluoroscopy system is an image intensified fluoroscopic X-ray imaging system consisting of two mobile units: a mobile acquisition unit and a monitor cart as the image display station. The mobile acquisition unit is comprised of the X-ray control, the C-arm which supports the single-tank high-frequency generator/X-ray tube assembly, the flat panel detector and user controls. The monitor cart connects to the acquisition unit by a cable. It integrates the TFT flat panel displays, Digital Image Processing System, user controls and image storage devices (DVD, USB).

The document describes the Siemens Cios Fusion, a mobile X-ray system. The acceptance criteria and the study proving the device meets them are detailed in sections 9, 11, 12, 14, 15, and 16 of the 510(k) summary.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• 1020.30 Diagnostic X-Ray Systems and their major components
• 1020.31 Radiographic Equipment
• 1020.32 Fluoroscopic equipment
• 1040.10 Laser products |
  | Voluntary Consensus Standards | Conformity to recognized standards (e.g., IEC 60601 series, ISO 14971, IEC 62304, DICOM) | Cios Fusion complies with:
• IEC 60601-1:2005 (Medical electrical equipment - General requirements for basic safety and essential performance)
• IEC 60601-1-2:2007 (Electromagnetic compatibility)
• IEC 60601-1-3:2008 (Radiation protection in diagnostic X-ray equipment)
• IEC 60601-2-28:2010 (X-ray tube assemblies for medical diagnosis)
• IEC 60601-2-43:2010 (X-ray equipment for interventional procedures)
• IEC 60601-2-54:2009 (X-ray equipment for radiography and radioscopy)
• ISO 14971:2007 (Application of risk management to medical devices)
• DICOM Set PS 3.1 - 3.20 (2011)
• IEC 60825-1:2007 (Safety of laser products)
• IEC 62304:2006 (Medical device software life-cycle processes)
• IEC 62366:2007 (Usability engineering)
• PAS 61910-1:2007 (Radiation dose documentation) |
  | Bench Testing (Functional/Performance) | Successful verification of all testable requirements in specifications | Unit, Subsystem, and System Integration testing performed. All testable requirements in Engineering Requirements Specifications, Subsystem Requirements Specifications, and Risk Management Hazard keys were successfully verified and traced. Software verification and regression testing met previously determined acceptance criteria. |
  | Non-Clinical Testing (Detector Evaluation) | Conformance to FDA guidance document for solid-state X-ray imaging devices | Detectors evaluated according to "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices." System-level validation and regression testing performed successfully, demonstrating the device meets acceptance criteria as noted in system test plans. System functions as intended and performs as designed. |
  | Clinical Testing (Usability and Image Quality) | Adequate usability and image quality for intended use; improved image quality compared to predicate. | Evaluated in a clinical environment for approximately four weeks. More than 30 patients examined during Ortho/Trauma procedures (upper/lower extremities, shoulder, hip/pelvis, cervical/lumbar spine). Found to provide better, more detailed image quality compared to the Secondary predicate device Arcadis Varic. Usability and image quality confirmed adequate. |
  | Electrical Safety and Electromagnetic Compatibility (EMC) | Compliance with relevant safety and EMC standards | System complies with IEC 60601-1, IEC 60601-2-43, and IEC 60601-2-54 for safety, and IEC 60601-1-2 for EMC. |
  | Software Verification and Validation | Documentation provided per FDA guidance; software performs as intended. | Software verification and validation testing conducted, and documentation provided per FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "moderate" level of concern. Design requirements fulfilled, system functions as intended. |
  | Safety and Effectiveness (General) | No new potential safety risks; safe and effective use. | Instructions for use, cautions, and warnings provided. Risk management via Risk Analysis and hazard analysis. Control through software means, user instructions, verification, and validation. Adherence to recognized industry practice and international standards. Device found substantially equivalent to predicates without new safety risks. |

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

• Test Set Sample Size: For the clinical testing (Section 14), "More than 30 patients" were examined.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data. It states the testing was done "in a clinical environment," suggesting real-world data. It implies a prospective collection for the purpose of this validation, as it describes the device being evaluated over approximately four weeks with patients.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth in the clinical study. It mentions that "operators are health care professionals familiar with and responsible for the evaluating and post processing of X-ray images" (Section 13) and that "usability and image quality are adequate for its intended use" (Section 14), which implies evaluation by clinical professionals. However, specific numbers or qualifications like "radiologist with 10 years of experience" are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The clinical testing involved evaluation of image quality and usability, and the conclusion ("Cios Fusion was found to provide a better, more detailed image quality") suggests a consensus or comparison by the evaluating clinicians rather than a specific multi-reader adjudication process.

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

• MRMC Study: No, an MRMC comparative effectiveness study, specifically one evaluating human reader improvement with AI assistance, was not performed.
• Effect Size: Not applicable, as no MRMC study with AI assistance was conducted. The study focused on the device's standalone performance and image quality comparison to a predicate, not on human-AI collaboration.

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

Yes, the testing presented is primarily focused on the standalone performance of the Cios Fusion system. This includes bench testing (unit, subsystem, system integration), non-clinical detector evaluation, electrical safety, EMC, and software verification, as well as a clinical evaluation where the device's image quality and usability were assessed. The device itself is an imaging system, not an AI algorithm, so its "standalone" performance refers to its functional operation as an X-ray system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the clinical testing (Section 14) relating to image quality and usability, the ground truth was based on clinical evaluation and consensus/assessment by healthcare professionals during actual patient examinations. The statement "The Cios Fusion was found to provide a better, more detailed image quality as compared to the Secondary predicate device Arcadis Varic" indicates a qualitative expert assessment of the images produced.

8. The Sample Size for the Training Set

Not applicable. The Cios Fusion is an X-ray imaging system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The document describes traditional medical device validation through engineering, non-clinical, and clinical performance testing.

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

Not applicable, as there is no mention of a "training set" for an AI algorithm.

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