(74 days)
The Cios Spin is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patients 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 Cios Spin (VA31A) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Spin provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components:
a. The C-arm with 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 be lifted vertically, shifted to the side and move forward/backward by an operator.
b. The second unit is the image display station with a moveable trolley for the image processing and storage system, image display and documentation. Both units are connected to each other with a cable.
The following modifications were made to the Predicate Device the Cios Spin Mobile X-ray System cleared under Premarket Notification K210054 on February 5, 2021. Siemens Medical Solutions USA, Inc. submits this Traditional 510(k) to request clearance for the Subject Device Cios Spin (VA31A). The following modification is incorporated in the Predicate Device to create the Subject Device, for which Siemens is seeking 510(k) clearance:
- Software updated from VA30 to VA31A to support the below software features
A. Updated Retina 3D for optional enlarged 3D Volume of 25cm x 25cm x 16cm
B. Introduction of NaviLink 3D Lite
C. Universal Navigation Interface (UNI)
D. Updated InstantLink with Extended NXS Interface - Updated Collimator
- Updated FLC Imaging system PC with new PC hardware Updated AppHost PC with High Performance Graphic Card
- New Eaton UPS 5P 850i G2 as successor of UPS 5P 850i due to obsolescense
Based on the provided FDA 510(k) clearance letter for the Siemens Cios Spin (VA31A), here's an analysis of the acceptance criteria and the study proving the device meets them:
Important Note: The provided document is a 510(k) summary, which often summarizes testing without providing granular details on study design, sample sizes, and ground truth establishment to the same extent as a full clinical study report. Therefore, some information requested (e.g., specific number of experts for ground truth, adjudication methods) may not be explicitly stated in this summary. The focus of this 510(k) is primarily on demonstrating substantial equivalence to a predicate device, especially for software and hardware modifications, rather than a de novo effectiveness study.
Acceptance Criteria and Reported Device Performance
The 510(k) summary primarily focuses on demonstrating that the modifications to the Cios Spin (VA31A) do not introduce new safety or effectiveness concerns compared to its predicate device (Cios Spin VA30) and a reference device (CIARTIC Move VB10A) that incorporates some of the new features. The acceptance criteria are implicitly tied to meeting various industry standards and demonstrating functionality and safety through non-clinical performance testing.
Table 1: Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit from Text) | Reported Device Performance / Evidence |
|---|---|---|
| Software Functionality | Software specifications met acceptance criteria as stated in test plans. | "All test results met all acceptance criteria." |
| Enlarged Volume Field of View (Retina 3D) | Functionality and performance of new 25cm x 25cm x 16cm 3D volume. | "A non-clinical test 'Enlarged Volume Field of View' testing were conducted." The feature was cleared in the CIARTIC Move (K233748), implying its performance was previously validated. |
| NaviLink 3D Lite Functions | Functionality and performance of the new navigation interface. | Part of software updates VA31A; "All test results met all acceptance criteria." |
| Universal Navigation Interface (UNI) | Functionality and performance of UNI. | Part of software updates VA31A; "All test results met all acceptance criteria." UNI was present in the reference device CIARTIC Move (K233748). |
| InstantLink with Extended NXS Interface | Functionality and performance of updated interface. | Part of software updates VA31A; "All test results met all acceptance criteria." |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-2-43, IEC 60601-2-54. | "The system complies with the IEC 60601-1, IEC 60601-2-43, and IEC 60601-2-54 standards for safety." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | "The system complies with... the IEC 60601-1-2 standard for EMC." |
| Human Factors/Usability | Device is safe and effective for intended users, uses, and environments. Human factors addressed. | "The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual and in clinical use tests with customer reports and feedback forms." |
| Risk Mitigation | Identified hazards are controlled; risk analysis completed. | "The Risk analysis was completed, and risk control was implemented to mitigate identified hazards." |
| Overall Safety & Effectiveness | No new issues of safety or effectiveness introduced by modifications. | "Results of all conducted testing and clinical assessments were found acceptable and do not raise any new issues of safety or effectiveness." |
| Compliance with Standards/Regulations | Adherence to various 21 CFR regulations and standards (e.g., ISO 14971, IEC 62304). | Extensive list of complied standards, including 21 CFR sections 1020.30, 1020.32, and specific IEC/ISO standards mentioned in Section 9. |
Study Details Proving Device Meets Acceptance Criteria
The study described is primarily a non-clinical performance testing and software verification and validation effort rather than a traditional clinical trial.
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Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patients or images for performance evaluation. The testing described is "Unit, Subsystem, and System Integration testing" and "software verification and regression testing." This type of testing uses a diverse set of test cases designed to cover functionality, performance, and safety requirements. For the "Enlarged Volume Field of View," it's a non-clinical test, likely using phantoms or simulated data.
- Data Provenance: Not applicable in terms of patient data provenance for the non-clinical and software testing described. This is bench testing and software validation. Customer reports and feedback forms are mentioned for human factors, but specific details on their origin (country, etc.) are not provided. The manufacturing site is Kemnath, Germany.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not explicitly stated. For non-clinical performance and software testing, "ground truth" is typically established by engineering specifications, known correct outputs for given inputs, and compliance with industry standards. If clinical use tests involved subjective evaluation, the number and qualifications of experts are not detailed, but they are implied to be "healthcare professionals" (operators are "adequately trained").
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Adjudication method for the test set:
- Not applicable/Not explicitly stated. For software and bench testing, adjudication usually refers to a process of resolving discrepancies in ratings or measurements. Given the nature of this submission (software/hardware modifications and non-clinical testing), formal clinical adjudication methods (like 2+1, 3+1 for image reviews) are not described as part of the primary evidence. Acceptance is based on test cases meeting predefined engineering requirements.
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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 study was not conducted. This 510(k) is for a mobile X-ray system with software and hardware updates, not an AI-assisted diagnostic device where evaluating human reader performance with and without AI would be relevant. The "AI" mentioned (Retina 3D, NaviLink 3D) refers to advanced imaging/navigation features, not machine learning for diagnostic interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "non-clinical test 'Enlarged Volume Field of View' testing" and other "Unit, Subsystem, and System Integration testing" for functionality and performance are essentially standalone tests of the device's components and software without immediate human interpretation in a diagnostic loop. The acceptance criteria for these tests refer to technical performance endpoints, not diagnostic accuracy.
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The type of ground truth used:
- Engineering Specifications and Standard Compliance: For the performance and safety testing, the "ground truth" is adherence to predefined engineering requirements (e.g., image dimensions, system response times, electrical safety limits) and compliance with national and international industry standards (e.g., IEC 60601 series, ISO 14971, NEMA PS 3.1).
- For the Human Factors Usability Validation, "customer reports and feedback forms" serve as a form of "ground truth" regarding user experience and usability.
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The sample size for the training set:
- Not applicable. This submission describes modifications to an X-ray imaging system, not the development of a machine learning algorithm that requires a separate training set. The existing software (VA30) was updated to VA31A. The "training" for the software itself would have occurred during its initial development, not for this specific 510(k) submission.
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How the ground truth for the training set was established:
- Not applicable. As above, this information is not relevant to this specific 510(k) submission, as it focuses on modifications to an existing device rather than the development of a new AI/ML algorithm requiring a training set and its associated ground truth.
§ 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.