(117 days)
The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediatric populations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture 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 radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine, and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required. The visualization of such anatomical structures assists the clinician in 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 employs X-rays as its imaging technology for visualizing human anatomy. The X-ray tube in the generator produces Xrays, 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 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).
Motorization of vertical axis as well as manual or optionally motorized three axes 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.
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, 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 describes a 510(k) premarket notification for the Ziehm Vision RFD, an image-intensified fluoroscopic x-ray system. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K132904), rather than detailing specific acceptance criteria and a standalone human reader study with quantitative metrics for AI performance.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment for an AI-driven device are not explicitly present in this regulatory submission. This document primarily focuses on demonstrating that the modified device (Ziehm Vision RFD) is substantially equivalent to its predicate device (also Ziehm Vision RFD, K132904), which is a conventional fluoroscopic x-ray system, not an AI-assisted one in the typical sense of a diagnostic AI algorithm.
However, I can extract the information provided that is relevant to "device acceptance criteria" in broad terms and the "study" (non-clinical testing) that supports these criteria for this imaging device.
Here's an interpretation based on the provided text:
Device Name: Ziehm Vision RFD (Modified)
Type of Device: Image-intensified fluoroscopic x-ray system (medical imaging device)
Acceptance Criteria (Interpreted from the document's focus on substantial equivalence and safety/performance):
The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device (Ziehm Vision RFD, K132904) in terms of:
- Indications for Use
- Technological Characteristics (including x-ray generator, image detector, controls, and software architecture)
- Safety and Effectiveness (including radiation safety, electrical safety, electromagnetic compatibility, and image quality).
Given this context, the performance is generally described in relation to the predicate, with a focus on maintaining or improving upon key aspects without introducing new safety or effectiveness concerns.
| Category | Acceptance Criteria (Implicitly based on predicate equivalence and standards) | Reported Device Performance and Discussion |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate, maintaining the same scope of intended medical imaging procedures for adult and pediatric populations, including pulsed/continuous fluoroscopic digital imaging, DSA, and cine image capture for diagnostic, interventional, and surgical procedures requiring visualization of complex anatomical structures. Not for direct radiographic film exposures, mammography, or near MRI systems. | "Substantially Equivalent" to predicate. Slight modification in wording for "joint fractures of the upper and lower extremities" (predicate had only "upper") and removal of "in and around high magnetic fields" for the predicate. However, the overall scope remains consistent. |
| Technological Characteristics | Maintenance of fundamental control, scientific technology, image processing applications, and core components similar to the predicate. Minor enhancements should not alter the fundamental principles. | X-ray Generator: Higher maximum power output (e.g., new 30 kW variant vs. predicate's 25 kW max.), but design and housing are identical. The general system exposure control technology and operational functionality remain identical. |
| Image Detector, Collimator, Laser, Electrical, Mechanics, Monitors, User Interface, Radiation Switches: Identical to predicate. | ||
| Digital Image Processing: |
- Enhanced Vessel Visualization (Option): New function not present in predicate. No specific performance criterion mentioned, but deemed to not raise new questions of safety/effectiveness.
- 2D Measurement Function (within AMT Option): New function not present in predicate (predicate only had "Mark anatomical structures"). Deemed similar to predicate's general functionality and not raising new safety/effectiveness questions.
Data Organization (Radiation Dose): New features for "Calculated Dose Area Product (DAP) value tagged to stored image" and "Air Kerma dose display/value tagged to stored image". These features "improve the clinician's ability to obtain more information as to the dose for each image" and are therefore an improvement over the predicate, supporting substantial equivalence.
Software: Architecture "nearly identical" with modifications to support new features (Enhanced Vessel Visualization, 2D measurement). |
| Safety and Performance| Compliance with relevant FDA regulations, recognized consensus standards (e.g., IEC 60601 series, ANSI/AAMI ES60601-1, ISO 14971), and FDA guidance documents. Risk analysis and verification/validation testing should confirm designed performance and not raise new safety/effectiveness concerns. Image quality should be "comparable" to the predicate. | Demonstrated compliance with:
• 21 CFR 1020.30-32 (Federal Performance Standard for Diagnostic X-ray Systems)
• ANSI/AAMI ES60601-1 (Electrical Safety)
• IEC 60601-1-2 (EMC)
• IEC 60601-1-3 (Radiation Protection)
• IEC 60601-1-6 (Usability)
• IEC 60601-2-43 (X-ray for interventional procedures)
• IEC 60601-2-54 (X-ray for radiography and radioscopy)
• IEC 60825-1 (Laser Safety)
• ISO 14971 (Risk Management)
• FDA guidance documents for diagnostic X-ray systems, wireless technology, interoperable devices, solid-state X-ray imaging devices, pediatric medical devices, and software in medical devices.
Image Quality: "Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality."
Dose: "An assessment regarding the low dose functionality of the modified Ziehm Vision RFD shows the ability to reduce dose for certain applications." "Non-clinical imaging and dose testing methods demonstrated the device capability to provide both reduced dose while maintaining image quality." |
Study Proving Device Meets Acceptance Criteria (Non-Clinical Testing):
The document explicitly states: "Summary of Non-Ziehm Vision RFD is based on direct modifications to cleared predicate device Clinical Test Data: Ziehm Vision RFD (K132904)." This means they did not perform new clinical studies but relied on bench testing and comparisons to the predicate.
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Sample sizes used for the test set and the data provenance:
- Test Set Description: "Non-clinical image and dose Lab testing, were employed."
- Data Provenance: Not explicitly stated (e.g., country of origin), but implies lab-based, phantom testing.
- Sample Size:
- "Anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were employed."
- "image comparison sets taken were representative of both the adult and pediatric populations."
- Specific number of phantoms or images is NOT provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "A Radiologist performed an assessment of individual image sets." (Implies one radiologist)
- Qualifications of Experts: "A Radiologist" - no further details provided regarding experience, subspecialty, or board certification.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- "A Radiologist performed an assessment of individual image sets." This suggests no formal adjudication among multiple readers was performed for the non-clinical image comparison. It was a single-reader assessment.
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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 performed as this is a traditional imaging device, not an AI-assisted diagnostic algorithm in the sense of comparing human performance with and without AI. The comparison was for image quality equivalence between the modified device and its predicate.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a hardware/software imaging system, not a standalone AI algorithm that performs a diagnostic task. Its "performance" is in generating images and enabling certain features, not in making a call by itself. The "Enhanced Vessel Visualization" is an imaging feature, not a standalone diagnostic AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For image quality comparison: Radiologist assessment of images acquired from anthropomorphic and anatomical simulation phantoms. This is a form of expert assessment of image quality based on known phantom characteristics, rather than true clinical ground truth (like a biopsy or outcome).
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The sample size for the training set:
- N/A. This approval is for an imaging system, not a machine learning model that requires a "training set" in the typical ML sense. The software modifications are described as supporting "functionality, image processing applications related to the optional device specific features," implying traditional software development and image processing rather than deep learning.
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How the ground truth for the training set was established:
- N/A. As above, no training set for a machine learning model is mentioned or implied.
§ 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.