(28 days)
The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations.
The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures.
The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures.
The visualization of such anatomical structures assists the clinical outcome. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.
The ZIEHM VISION RFD 3D employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D imaging. The Xray tube in the generator produces X-rays, quided toward the patient under control of the user at the direction of a physician who determines the specific clinical procedure. The images from the system assist the physicians in visualizing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures. The device provides both real-time image capture and post capture visualization and of in vivo surgical procedures and post-surgical outcomes.
The Ziehm Vision RFD 3D mobile fluoroscopy system is a flat panel detector (FPD) Computed tomography x-ray system and fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator, and the image receptor Flat Panel Detector (FPD).
The device performs both 2D medical imaging and the specialized 4 axes of motorized movement necessary for the 3D imaging. This provides the user/operator the option to use manual or motorized linear and rotational movements of the C- Profile for positioning of the imaging components at various angles and distances with respect to the patient using a control interface, Vision Center, Remote Vision Center or remote Position Control Center.
The motorization of the 4 axes provides the user an alternative for visualizing anatomical structures using a variable iso-centric location. The system working with a variable iso-center allows freely selectable positions of patient anatomy. The variable iso-center and distance control ensures that anatomical structures are safely visualized from different angles without re-adjusting the C-arm or moving the patient. The iso-center is not restricted to orbital movements and can hold this iso-center during angulations and vertical travel using the 4 motorized axes. This same motion control provides the bases for 3D views of the patient anatomy. These 3D views are generated by means of an iterative algorithm. The system uses the images of a scan captured with relation to a predefined scan center to compute the three-dimensional representation of an object. The 3D views are always displayed on the reference screen of the monitor cart. It is possible to display multiplanar reconstructions, orthogonal or freely selectable sections, and different surface reconstructions.
The Distance Control surface detection integrated around the lower edge of the flat panel detects objects, such as patients. When the flat panel approaches an object, the device reduces speed, slowing the motorized movement. The movement stops immediately before entering a defined safety zone.
The mobile stand supports the optional wireless footswitch for optimum positioning for the surgeon by removing the cable on the floor.
The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, 2D image processing, Optional 3D image processing, user controls and image recording devices. Interfaces provided for optional peripheral devices such as external monitors, thermal video printers, wireless video display, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces.
The provided text is a 510(k) Premarket Notification for the Ziehm Vision RFD 3D system. This document is a summary demonstrating substantial equivalence to a predicate device (K142740), rather than a detailed report of a clinical study designed to measure specific performance criteria with acceptance thresholds.
Therefore, the document does not contain the direct acceptance criteria or a detailed study report with quantitative performance metrics for the device's image quality or clinical efficacy in the format requested.
Instead, it relies on demonstrating that the modified device's performance, particularly image quality and dose, is comparable to the predicate device and meets relevant regulatory standards. The "study" mentioned is primarily non-clinical bench testing and image comparison rather than a multi-reader, multi-case (MRMC) clinical efficacy trial or a standalone AI performance study.
Here's an attempt to extract and infer information based on the provided text, while highlighting what is not present:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary does not outline specific, quantitative acceptance criteria in the format of a table with numerical thresholds for performance (e.g., minimum sensitivity, AUC, or Dice scores). Since this is a submission demonstrating substantial equivalence to a predicate device (K142740), the "acceptance criteria" are implicitly met by demonstrating that the modified device performs comparably to the predicate and complies with relevant safety and performance standards.
The "study" conducted for performance evaluation was primarily non-clinical bench testing and image comparison, not a large-scale clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit quantitative acceptance criteria for image quality or clinical performance are not stated in this 510(k) summary. The "performance" assessment is based on comparability to the predicate device and compliance with general radiographic performance standards.
| Criterion Type | Implicit Acceptance Criterion (Inferred from Document) | Reported Device Performance |
|---|---|---|
| Image Quality | Comparable image quality to predicate device (Ziehm Vision RFD 3D K142740). | "Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality." |
| Radiation Dose | Ability to reduce dose for certain applications while maintaining image quality. | "an assessment regarding the low dose functionality of the modified Ziehm Vision RFD 3D shows the ability to reduce dose for certain applications." |
| Compliance with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment (e.g., leakage radiation, peak tube potential, entrance exposure rates, beam-limiting alignment). | "performance testing confirmed that the modified Ziehm Vision RFD 3D complies with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment and with relevant safety standards such as IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54." | |
| Electrical Safety & EMC | Compliance with electrical safety and electromagnetic compatibility standards. | "Testing regarding electrical safety according to ANSI/AAMI ES60601-1 and regarding electromagnetic compatibility according to IEC 60601-1-2 was performed. The test results show compliance with both standards." |
| Wireless/Interoperability | Wireless and interoperable features do not affect safety and effectiveness. | "Testing according to Guidance's 'Radio Frequency Wireless Technology in Medical Devices' and 'Design Considerations and Premarket Submissions Recommendations for Interoperable Medical Devices' show, neither the wireless features nor the interoperable interfaces of the device affect the safety and effectiveness." |
| Software | Compliance with software and cybersecurity guidance. | "Software testing was performed as required by 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' and 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices'." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical count of cases/patients. "Sets of images" were used for non-clinical image comparison. For the dose and image quality assessment, "Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed."
- Data Provenance: The data appears to come from non-clinical bench testing in a controlled lab environment, likely in Germany (where Ziehm Imaging GmbH is located) or at certified testing facilities. It is retrospective in the sense that it's performed on phantoms and not derived from new clinical patient studies. No mention of country of origin for clinical patient data, as this was not a clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: "A Radiologist performed an assessment of individual image sets." This implies one radiologist.
- Qualifications: "A Radiologist." No specific details on years of experience or sub-specialty are provided in this summary.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or not specified beyond a single radiologist's assessment. There is no mention of consensus reading, 2+1, or 3+1 methods, typically used in multi-reader studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was NOT done. The document explicitly states "Non-clinical image comparison... shows equivalence regarding image quality." The assessment was performed by "A Radiologist." There is no mention of multiple readers or a comparative study measuring how human readers improve with or without AI assistance, as this is an imaging device, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- This question is not applicable in the context of this 510(k). The device is an X-ray fluoroscopic system, not an AI algorithm intended for standalone diagnostic performance. The "algorithm" refers to iterative reconstruction for 3D views, which is an intrinsic part of the image generation process, not a separate diagnostic algorithm.
7. The Type of Ground Truth Used
- For Image Quality: The ground truth for image quality was established by a Radiologist's assessment of image sets from anthropomorphic phantoms and anatomical simulation phantoms, comparing them to images from the predicate device. This is a form of "expert qualitative assessment" on phantom data simulating real anatomy, rather than ground truth from pathology, outcomes data, or deep consensus of multiple experts on patient cases.
8. The Sample Size for the Training Set
- Not applicable / Not explicitly stated. This device is an X-ray imaging system. While it uses digital image processing and potentially iterative reconstruction algorithms for 3D views, the document does not describe it as an AI/ML device in the sense of requiring a "training set" for a learning algorithm that generates diagnostic outputs. The underlying "algorithms" (e.g., for 3D reconstruction) are likely deterministic or model-based, not machine learning algorithms trained on large datasets.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, no "training set" is described for this device in the context of AI/ML.
§ 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.