(45 days)
The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine. The Cios Select can operate in three different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
The Siemens Healthineers Cios Select mobile fluoroscopy C-arm system is an 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 Imaging Processing System, user controls and image storage devices (DVD, USB).
The provided text describes a 510(k) summary for the Siemens Cios Select (VA20) mobile X-ray system. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and non-clinical performance testing. It does not contain information about a study proving the device meets acceptance criteria in the context of clinical performance metrics like sensitivity or specificity. Instead, the "acceptance criteria" discussed relate to passing engineering verification and validation tests against established standards and guidance documents.
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 present acceptance criteria or reported device performance in the format of specific clinical metrics (e.g., sensitivity, specificity, AUC) for the device's diagnostic capabilities. Instead, the "acceptance criteria" are related to compliance with consensus standards, regulatory guidance, and internal software/hardware validation.
| Acceptance Criteria (Type) | Reported Device Performance |
|---|---|
| Conformity to 21 CFR Federal Performance Standards | Complies with 1020.30, 1020.32, 1040.10 |
| Conformity to Voluntary FDA Recognized Consensus Standards | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 62366-1, ISO 14971:2012, IEC 62304, IEC 60601-2-28, IEC 60601-2-43, IEC 60601-2-54, NEMA PS 3.1 - 3.20 (DICOM), IEC 60825-1, IEC 61910-1 |
| Software Specification Fulfillment (for new features) | All software specifications met the acceptance criteria and worked as intended. |
| Risk Management Hazard Mitigation | Risk analysis completed, risk control implemented, all test results passed. |
| Electrical Safety and EMC Testing | Complies with IEC 60601-1, IEC 60601-2-43, IEC 60601-2-54, IEC 60601-1-2. |
| Human Factors and Usability Validation | Human factors addressed, acceptable results from system test (operator's manual) and clinical use tests (customer report & feedback). Customer employees trained. |
| Cybersecurity Requirements | Conforms to cybersecurity requirements, cybersecurity statement provided. |
| System Performance & Imaging Performance Evaluation (for SSXI) | Acceptable results performed with "X-ray Imaging Devices- Laboratory Image Quality and Dose Assessment, Tests and Standards". |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that the tests conducted were non-clinical (bench testing, software verification, electrical safety, EMC, etc.). Therefore, there is no "test set" in the sense of patient data, clinical images, or human subject data. The provenance of such data, therefore, is not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
Not applicable, as no clinical test set with corresponding ground truth established by experts is mentioned in the non-clinical testing section.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication is mentioned.
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 MRMC comparative effectiveness study is mentioned. The submission focuses on the safety and effectiveness of the device as a standalone imaging system, not on its impact on human reader performance or the improvement provided by AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This submission is for a medical imaging device (C-arm X-ray system) and its associated software and hardware updates. The "standalone" performance described refers to the device itself operating according to its technical specifications and regulatory standards. It is an "algorithm only" in the sense that the software processes images without human intervention, but the device's function is to acquire and display images for human interpretation. The non-clinical testing evaluates this standalone device performance.
7. The Type of Ground Truth Used
For the non-clinical testing performed, the "ground truth" refers to predefined technical specifications, regulatory standards, and expected functional outputs. For example:
- Engineering Requirements Specifications keys: The device's output and behavior are compared against these internal design requirements.
- Voluntary Conformance Standards (e.g., IEC, ISO, NEMA): The device's performance (e.g., electrical safety, EMC, software lifecycle processes, radiation protection) is measured against these established industry standards.
- FDA Guidance Documents: The implementation and testing adhere to these regulatory expectations (e.g., software guidance, wireless guidance, SSXI guidance).
- Hazard Analysis/Risk Management: Identification and mitigation of potential hazards serve as "ground truth" for safety assessments.
8. The Sample Size for the Training Set
No training set (in the context of machine learning or AI algorithm development) is mentioned. The submission describes updates to an existing X-ray device and its software based on traditional engineering development and testing, not AI-driven development.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set (for AI) is mentioned in the document.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.