(168 days)
The ZIEHM VISION RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital imuging, 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 included but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional electrophysiology, angiography, 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 ficids. The visualization of such unatomical 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 ZIEIIM VISION RFD Mobile Stand incorporates a small compact design making the positioning of the c-arm in relation to the patient easier for the operator. The C-profile provides fixed distance mounting of the generator and Flat-panel Detector (SSXI) and manual rotation around a non iso-centric location. The mobile stand allows manual rotational and linear movements with a motorized vertical movement for positioning the c-arm at various angles and distances for visualization of pation's anatomical structures. The high frequency generator with dual focus rotating anode x-ray lube, advanced active cooling, x-ray control, are assembled in one housing in a single mono-block generator tube housing assembly, with the virtual collimator mounting to the housing assemble. The Zichm Vision RFD can have one of the following two generators 7.5 kW or optional 20 kW. They both provide pulsed and continuous fluoroscopy operations including a special digital radiography (snapshot) mode. The VisionCenter is a ccuralized touch screen panel providing the uscr/operator with a clear graphicul user Interface including the xray control panel. The ZIEHM VISION RFD Monitor Cart workstation consists of a mechanical cart assembly, supporting dual high-resolution flat panel LCD display monitors and interfaces are provided for preinherial devices such as external monitors, video printers, injectors and storage devices (USB, DVD).
This K083545 submission pertains to a conventional medical device (X-ray system), not an AI/ML-driven device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, or reader studies) is not directly applicable.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices by complying with established performance standards for X-ray systems and ensuring safety and effectiveness.
Here's how the provided information relates to your request, interpreted for a conventional medical device submission:
1. A table of acceptance criteria and the reported device performance
The document lists several international and federal standards that the device must meet. These standards themselves define the "acceptance criteria" for various aspects of the X-ray system's performance, safety, and electromagnetic compatibility. The "reported device performance" is implicitly that the device has been tested and shown to meet all applicable requirements of these standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Implied) |
|---|---|
| 21 CFR 1020.30-32 (Federal Performance Standard for Diagnostic X-ray Systems) | Device has been tested and shown to meet these requirements. |
| 93/42/EEC - Annex II (EC directive of the Medical Devices Directive) | Device has been tested and shown to meet these requirements. |
| IEC 60601-1 (Medical Electrical Equipment, General Requirements for Safety) | Device has been tested and shown to meet these requirements. |
| IEC 60601-1-2 (Medical Electrical Equipment, Electromagnetic Compatibility) | Device has been tested and shown to meet these requirements. |
| IEC 60601-1-3 (Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray Equipment) | Device has been tested and shown to meet these requirements. |
| IEC 60601-1-4 (General requirements for safety, Programmable electrical medical systems) | Device has been tested and shown to meet these requirements. |
| IEC 60601-2-7 (Medical Electrical Equipment, Safety of HV/X-ray Generators) | Device has been tested and shown to meet these requirements. |
| IEC 60601-2-28 (Medical Electrical Equipment, Safety of X-Ray Source Assemblies and X-Ray Tube Assemblies for Medical Diagnosis) | Device has been tested and shown to meet these requirements. |
| IEC 60601-2-32 (Medical Electrical Equipment, Safety of Associated X-ray Equipment) | Device has been tested and shown to meet these requirements. |
| IEC60601-2-43 (Particular requirements for the safety of X-Ray equipment for interventional procedures) | Device has been tested and shown to meet these requirements. |
| IEC 60825-1 (Safety of laser products, Equipment Safety, requirements, and user guide) | Device has been tested and shown to meet these requirements. |
| IEC 14971 (Risk Management) | Device has been tested and shown to meet these requirements. |
The study that "proves the device meets the acceptance criteria" in this context would be the detailed testing and verification reports that demonstrate compliance with each listed standard. These reports are typically part of the full 510(k) submission, though not fully detailed in this summary. The summary concludes that the device "shall be tested and be shown to meet the appropriate requirements of the following standards prior to being marketed," implying that these tests were conducted and compliance was achieved.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and therefore, not provided in this 510(k) summary for a conventional X-ray system. These details are pertinent to AI/ML diagnostic or prognostic devices that analyze medical images or data. For an X-ray machine, the "test set" would be the physical device itself undergoing engineering and performance tests according to the standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device. "Ground truth" for an X-ray machine's performance involves objective physical measurements (e.g., radiation output, image resolution, dose levels) evaluated against engineering specifications and regulatory standards, not expert clinical interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this type of device. Adjudication methods are relevant in clinical studies where human interpretation of medical data is being evaluated, particularly for AI/ML devices.
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
This is not applicable to this type of device. MRMC studies are specific to evaluating the clinical impact of AI/ML systems on human reader performance. This submission is for the X-ray imaging hardware itself.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable to this type of device. "Standalone" performance refers to AI algorithms operating independently, which is not the function of an X-ray machine.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned, "ground truth" for this device refers to objective physical and technical specifications and compliance with regulatory standards. For example, the accuracy of the X-ray tube output, the resolution of the flat-panel detector, radiation leakage, and electrical safety are all measured against defined engineering and regulatory benchmarks.
8. The sample size for the training set
This is not applicable to this type of device. A "training set" is used in the development of AI/ML algorithms, not for the manufacturing and testing of conventional medical hardware.
9. How the ground truth for the training set was established
This is not applicable to this type of device.
§ 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.