(80 days)
The ZIEHM VISION RFD is intended for use in providing medical imaging, 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 in and around high magnetic fields. The visualization of such anatomical structures assists the clinician in the clinical outcome. At the discretion of a physician, the device may be used for other imaging applications.
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 mobile fluoroscopy system is a flat panel detector (FD) 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 (FD).
The proposed device will add motorized movement to three additional axes of the predicate device vertical motorized movement. 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 three axes provides the user an alternative for visualizing anatomical structures using a selectable iso-centric location. With the freely selectable iso-center and distance control, any given anatomical structure can be safely visualized from different angles without having to re-adjust the C-arm. The iso-center is not restricted to orbital movements, but is held during angulations and vertical travel using the now available 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 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, injectors and image storage devices (USB, DVD) and DICOM Network interfaces.
This document is a 510(k) Summary for the Ziehm Vision RFD, a mobile fluoroscopic C-Arm. It describes the device, its intended use, and affirms its substantial equivalence to a predicate device (K083545 Ziehm Vision RFD). The core of the submission focuses on modifications to an existing cleared device rather than presenting a novel AI-powered diagnostic system requiring specific performance metrics like sensitivity and specificity for disease detection.
Therefore, the provided text does not contain the acceptance criteria and study details in the format requested for an AI/ML-powered diagnostic device. Instead, it details regulatory compliance and verification/validation of design changes for an imaging hardware system.
Here's a breakdown of why the requested information isn't present in the document:
- Type of Device: The Ziehm Vision RFD is a fluoroscopic X-ray imaging system (hardware), not an AI-powered diagnostic algorithm designed to detect or classify medical conditions.
- Nature of Submission: This is a "Special 510(k) Submission" for modifications (adding motorized movement to three additional axes) to an already cleared predicate device. The focus is on demonstrating that the changes do not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to the predicate.
- Performance Metrics: The document discusses compliance with safety standards (e.g., IEC, 21 CFR 1020.30-32) and verification/validation testing for internal functional specifications and nonclinical image comparisons. It does not provide diagnostic performance metrics such as sensitivity, specificity, or AUC, which would be relevant for an AI diagnostic device.
To directly answer your request based on the provided text, while acknowledging its limitations for an AI/ML context:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (General) | Reported Device Performance (Summary) |
|---|---|
| Compliance with 21 CFR 1020.30-32 Federal Performance Standards for X-ray Fluoroscopic equipment and relevant voluntary safety standards (e.g., IEC 60601 series, ISO 14971). | Performance testing confirmed that the Ziehm Vision RFD complies with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment and with relevant voluntary safety standards for Electrical Safety and Electromagnetic Compatibility testing (specifically IEC standards listed). |
| Functional specifications (including software) are met. | Verification/validation testing to internal functional specifications (including software) was successfully conducted. Documentation provided demonstrates compliance of the modified device Ziehm Vision RFD to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation tests to software requirements and software risk hazards. |
| Comparable performance to the predicate device. | Nonclinical image comparisons involving flat panel display images taken with the new device and the predicate device were performed. The submission states that "The comparisons of the predicate device show the scientific and technology characteristics of the Ziehm Vision RFD are substantial equivalence to that of the predicate device." And "tests demonstrated that the device...performs comparably to the predicate device, and is substantially equivalent to the predicate device." |
| Safety and effectiveness are maintained. | Tests were performed on the Ziehm Vision RFD which demonstrated that the device is safe and effective. The verification/validation activities successfully confirmed device requirements are fulfilled, system functionality is consistent with the user needs, intended uses, and the Ziehm Vision RFD device correctly performs as designed, and raises no new questions regarding either safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "nonclinical image comparisons involving flat panel display images taken with the new device and the predicate device."
- Sample Size: Not specified. It refers to "images" generally.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given it's "nonclinical image comparisons," it likely refers to phantoms or test objects rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not mentioned. The testing described is primarily about technical performance, safety, and functional equivalence, not diagnostic accuracy requiring expert interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. No expert adjudication process is described for this type of hardware performance testing.
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, a MRMC comparative effectiveness study was not done. This document is for a medical imaging hardware system, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm. The device is a fluoroscopic X-ray system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The term "ground truth" as it applies to diagnostic accuracy for AI/ML models is not relevant here. The "truth" for the performance testing cited would be adherence to engineering specifications, safety standards, and image quality metrics verified against established benchmarks or the predicate device. For the "nonclinical image comparisons," the ground truth would be the known properties of the phantoms or test objects used.
8. The sample size for the training set
- Not applicable. The document describes a hardware device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
§ 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.