(80 days)
The Ziehm Solo 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 of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures. The visualization of such anatomical structures assists 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 Ziehm Solo 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. Additionally the device has the option of additional motorized axes of rotational movement for the (A-Axes C-profile motorization of the single A-axes provides the user an alternative for visualizing anatomical structures when performing certain procedures such as but not limited to working with lithotripsy procedures. A user touch screen provides for concise user selectable anatomical programs and X-ray technique control. Integrated highresolution flat panel display monitors directly mounted on the horizontal arm of the mobile stand 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 surqical 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 Solo 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 is a 510(k) summary for the "Ziehm Solo FD" mobile fluoroscopic X-ray system. It describes the device, its intended use, and a comparison to predicate devices, focusing on the substantial equivalence argument.
However, the document does not contain information about acceptance criteria for device performance, nor details of a study that proves the device meets specific performance criteria through a rigorous clinical or non-clinical evaluation with a defined test set, expert involvement, or adjudication methods.
The document discusses:
- Non-Clinical Test Data Summary: It states that verification/validation testing was successfully conducted on the Ziehm Solo FD, including internal functional specifications (software) and nonclinical image comparisons involving flat panel display images from the new device and the predicate Ziehm Vision² FD (K073346). It also mentions compliance with FDA requirements for diagnostic X-ray systems (e.g., leakage radiation, peak tube potential, fluoroscopic entrance exposure rates, beam-limiting alignment) and voluntary safety standards (IEC standards).
- Image Quality Metrics: It lists several physical characteristics of the X-ray image receptor and system performance, such as DQE (70%), resolution (4 lp/mm), dynamic range (68 dB), and grayscale (16 bit). These are technical specifications rather than acceptance criteria for a study.
Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria and the study that proves the device meets them because such detailed information is not present in this 510(k) summary.
The summary indicates that the device's substantial equivalence is based on:
- Direct modifications to cleared predicate devices.
- Compliance with engineering design controls and quality management systems.
- Verification and Validation testing to internal functional specifications (including software).
- Nonclinical image comparisons between the new device and a predicate device.
- Compliance with relevant FDA guidance documents and federal performance standards for X-ray fluoroscopic equipment, as well as voluntary safety standards (e.g., IEC standards).
The document is primarily focused on demonstrating substantial equivalence to predicates for regulatory approval, rather than reporting a clinical performance study with detailed acceptance criteria and ground truth establishment methods for a specific indication leveraging AI or advanced image analysis algorithms that would typically require such a study.
§ 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.