(28 days)
The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations.
The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops 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 lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures.
The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and Carm positioning data is required for Computer-Assisted Surgery 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 device Ziehm Vision RFD 3D is a medical Fluoroscopic X-ray imaging device used to assist trained physicians in the X-ray visualization of anatomical regions of a patient. The system is a non-contact device and is not intended to be in contact with patient to perform its intended use. The system provides X-ray image data by means of X-ray technique while the physician performs medical procedures and stores the image data temporarily.
The device Ziehm Vision RFD 3D consists of two physical elements. The first referred to as the "C-Arm" or Mobile Stand (MS) because of its wheeled base and C-profile shaped is referred to as the Monitor Cart (MC) because it provides real-time monitor displays for visualization and records of patient anatomy.
The provided text is a 510(k) summary for the Ziehm Vision RFD 3D, and it primarily focuses on establishing substantial equivalence to a predicate device due to a software update. It does not contain the detailed information required to describe acceptance criteria, performance studies, ground truth establishment, or human reader studies.
Specifically, the document states:
- "The key modification pertains to an updated release of the software, which incorporates an operating system upgrade from Ubuntu 16.04 to Ubuntu 20.04."
- "Ziehm Vision RFD 3D is based on the direct modifications to cleared predicate devices Ziehm Vision RFD 3D (K202360); The design changes were completed in accordance with Ziehm Imaging GmbH Quality Management System Design Controls and Engineering, standards compliance, and Verification and Validation testing were successfully conducted on the Ziehm Vision RFD 3D. Further compliance testing for the modified device to all FDA requirements as stated in 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' as applicable including software risk hazards was done. Tests performed on the Ziehm Vision RFD 3D, demonstrated that the device is safe and effective, performs comparably to the predicate devices, and substantially equivalent to the predicate devices."
This indicates that the submission is for a minor software update on an already cleared device. The focus is on demonstrating that the updated software does not negatively impact the existing performance and safety, rather than presenting a new clinical performance study for a novel AI algorithm or a significant hardware change.
Therefore, I cannot provide the requested information from the provided document because it is not present. The document focuses on regulatory compliance for a software update rather than detailed performance study results that would typically be required for a new or significantly modified AI-powered medical device.
To answer your specific questions based on the absence of this information in the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The document states "Tests performed on the Ziehm Vision RFD 3D, demonstrated that the device is safe and effective, performs comparably to the predicate devices..." but does not list specific performance metrics or acceptance criteria.
- Sample size used for the test set and the data provenance: Not provided. No specific test set or data provenance details are mentioned beyond general "Verification and Validation testing."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. The concept of "ground truth" as typically used in AI/image analysis studies is not discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
- 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: Not provided. This scenario (AI assistance to human readers) is not described or studied in the document.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. The device is an imaging system, not an AI algorithm for image analysis per se.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
- The sample size for the training set: Not applicable/Not provided. This is a software update for an imaging device; there is no mention of an "AI training set" in the context of this submission.
- How the ground truth for the training set was established: Not applicable/Not provided.
§ 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.