(186 days)
The Ziehm Vision FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy 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 FD mobile fluoroscopy system is comprised of a mobile stand with a C-Profile shaped support with both a mono-block high voltage generator assembly and Flat Panel image receptor. These attach to either end of a C-Profile providing a fixed SID. The device performs 2D medical imaging using 4 axes of manual movement and one vertical axes of motorized movement. A user touch screen provides for concise user selectable anatomical programs and Xray technique control. Integrated high-resolution flat panel display monitors directly mounted on the monitor cart providing the clinician with a precise angle for visualization of live fluoroscopic images of the patient's anatomy. This visualization helps to localize regions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless fluoroscopic footswitch. The Wireless footswitch operation allows for optimum positioning for the surgeon by removing the cable on the floor. The optional interface panel of the Ziehm Vision FD provides connection of peripheral devices such as external monitors, thermal video printers, and image storage devices (USB, DVD) and DICOM fixed wire and wireless network interfaces.
The provided document, a 510(k) Summary for the Ziehm Vision FD, describes a premarket notification for a modified fluoroscopic x-ray system. The study focuses on demonstrating substantial equivalence to a previously cleared predicate device (K193230), rather than establishing new acceptance criteria or proving clinical efficacy in a traditional sense. The changes primarily involve an additional 8-inch IGZO flat panel detector and updates to software and mechanical components.
Therefore, the acceptance criteria and study detailed below are framed within the context of a substantial equivalence submission, emphasizing performance comparison with a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the performance of the predicate device and the new device's ability to demonstrate comparable safety and effectiveness. The "reported device performance" refers to how the modified Ziehm Vision FD performs relative to the predicate.
| Acceptance Criteria (Implied by Predicate Performance & Safety Standards) | Reported Device Performance (Modified Ziehm Vision FD) |
|---|---|
| Image Quality: Comparable or improved image quality. | Non-clinical image comparison: Sets of images with the modified device and the predicate show equivalence regarding image quality. The modified device with IGZO has a higher resolution size compared to the predicate's 8-inch a-Si FPD, leading to better image quality. |
| Radiation Dose: Ability to reduce dose for certain applications. | Low-dose functionality assessment: Shows the ability to reduce dose for certain applications while maintaining image quality. Non-clinical image and dose lab testing with anatomical phantoms demonstrated the device's capability for reduced dose and maintained image quality. |
| Electrical Safety: Compliance with ANSI/AAMI ES60601-1. | Testing conducted: Test results show compliance with ANSI/AAMI ES60601-1. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2. | Testing conducted: Test results show compliance with IEC 60601-1-2. |
| X-Ray Performance: Compliance with 21 CFR 1020.30-32, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54. | Performance testing confirmed: Modified Ziehm Vision FD complies with 21 CFR 1020.30-32 and relevant safety standards (IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54). The device met all applicable sections of 21 CFR Subchapter J performance standards. |
| Software Safety & Effectiveness: No new safety or effectiveness concerns raised by software changes. | Software testing performed: As required by "Content of Premarket Submissions for Device Software Functions." Updates and optimizations of software features do not influence safety and effectiveness. Cybersecurity remains exactly the same as in the predicate device. |
| Mechanical & Other Changes: No influence on safety and effectiveness. | Mechanical changes: Length and height of mobile stand optimized; discontinued older FPD technology. These changes do not influence safety and effectiveness. Other changes: Updates to features like "Anatomical Marking Tool" and "Video output" are stated to have no influence on safety and effectiveness. Discontinued options do not impact core safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "non-clinical image comparison with sets of images" and "non-clinical image and dose Lab testing" using "anatomical phantoms."
- Test set sample size: Not explicitly stated as a number of images or cases. It refers to "sets of images" and "anatomical phantoms."
- Data provenance: Non-clinical (phantom-based) lab testing. The country of origin for the data is not specified but the manufacturer is based in Germany. The testing appears to be retrospective in comparison to the predicate, as it's a verification and validation activity for a modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of experts: "A Radiologist performed an assessment of individual image sets." This implies one radiologist.
- Qualifications of experts: The document only states "A Radiologist." No specific experience level (e.g., "10 years of experience") is provided.
4. Adjudication Method for the Test Set
The document mentions that "A Radiologist performed an assessment of individual image sets" and provided a "conclusion." This suggests a single expert review rather than a formal adjudication method (like 2+1 or 3+1 consensus).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical, phantom-based image comparison assessed by a single radiologist for substantial equivalence (comparability) in image quality and safety, not for an improvement in human reader performance with or without AI assistance. The device is an imaging system, not an AI-powered diagnostic aid meant to directly improve human reader effectiveness.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a fluoroscopic x-ray system, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm doesn't directly apply here. The performance tests described (image quality, dose, safety standards compliance) characterize the device's inherent capabilities without human interpretation as part of the core performance metric.
7. The Type of Ground Truth Used
For the non-clinical image comparison and dose testing, the "ground truth" was established using:
- Anatomical phantoms: These provide a known, controlled imaging target.
- Radiologist assessment: A radiologist's qualitative assessment of image quality and how it compares between the modified and predicate devices.
8. The Sample Size for the Training Set
This submission is for a medical imaging device (hardware and associated software), not a machine learning algorithm that requires a separate "training set." Therefore, the concept of a training set for an AI model is not applicable here. The software updates mentioned are optimizations and version changes, not a new AI model being trained.
9. How the Ground Truth for the Training Set was Established
As explained in point 8, a training set is not applicable to this device submission.
§ 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.