(92 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 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 angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room 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 orthopedical, 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 C-arm positioning data is required for Computer-Assisted Surgery procedures.
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 in any MRI environments.
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 Ziehm Vision RFD 3D is intended for use to provide 2D- and 3D-image data specifically but not limited in the field of orthopedics, traumatology and oral and maxillofacial surgery. Futhermore it is intended for use specifically but not limited to the imaging of soft tissues.
The modified subject device Ziehm Vision RFD 3D consists of two physical elements. The first referred to as the "C-Arm" of Mobile Stand (MS) because of its wheeled base and C-profile shaped image gantry; the second is referred to as the Monitor Cart (MC) because it provides real-time monitor displays for visualization and records of patient anatomy.
The modified Ziehm Vision RFD 3D employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Vision RFD 3D (K231701). Software architecture design is substantially equivalent to that of the predicate Ziehm Vision RFD 3D.
The provided text describes the Ziehm Vision RFD 3D, an image-intensified fluoroscopic X-ray system. However, it does not contain a specific table of acceptance criteria and reported device performance metrics in numerical form. The text primarily focuses on demonstrating substantial equivalence to a predicate device (K231701) through a software update and associated testing.
Here's a breakdown of the requested information based on the provided text, with "N/A" where the information is not explicitly stated in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a quantitative table of acceptance criteria or reported device performance for specific metrics like sensitivity, specificity, or accuracy. It states a qualitative criterion: "the image quality acquired with the test device is better or at least equal [to the predicate]."
| Acceptance Criteria (Qualitative) | Reported Device Performance (Qualitative) |
|---|---|
| Image quality better or equal to predicate system (K231701) | "Almost all images generated by the test device show more details, improved detectability and are sharper than the corresponding reference images." "From a radiological point of view the presented images that were acquired fulfil the requirements as stated by the intended use." |
| Compliance with relevant standards | The modified device is compliant with IEC 60601-1-2, 21 CFR 1020.30-32, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54. Software and cybersecurity testing performed as required. |
| Functionality consistent with intended use | "system functionality is consistent with the uses and 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
- Sample size: Not explicitly stated. The text mentions "anthropomorphic as well as motion-induced phantoms."
- Data provenance: Not explicitly stated beyond the use of "anthropomorphic phantoms so-called 'sectional phantoms'" constructed with a natural human skeleton cast in urethane material. This suggests a laboratory-based phantom study rather than patient data from a specific country or retrospective/prospective study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not explicitly stated.
- Qualifications of experts: Not explicitly stated, though the conclusions are made "From a radiological point of view," implying review by individuals with radiological expertise.
4. Adjudication method for the test set
- Not explicitly stated. The evaluation was a comparison of image quality between the test device and the predicate.
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
- Not applicable. This is a medical imaging device and the study described is a comparison of image quality against a predicate device, not an AI efficacy study with human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, in a sense. The image quality comparison was performed on images generated by the device itself (algorithm only, as it's an imaging system), and then subject to expert review as described in point 3.
7. The type of ground truth used
- The implicit ground truth was the image quality of the legally marketed predicate device (K231701). The study aimed to demonstrate that the image quality of the modified device was "better or at least equal" to this reference. The anthropomorphic phantoms serve as a reproducible standard for image acquisition comparison.
8. The sample size for the training set
- Not applicable. This is a medical imaging device undergoing a software update and comparison, not a machine learning model requiring a distinct training set.
9. How the ground truth for the training set was established
- Not applicable. (See point 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.