(99 days)
The Ziehm Vision FD is intended for use in providing medical imaging for general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures such as vascular cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, enom procedures, and where higher accuracy in Image geometry is required. This device does not support direct radiographic film exposures and is not in performing mammography. The system is not intended for use near MRI systems.
The Ziehm Vision 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. Tehse 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. A user touch screen provides for concise user selectable anatomical programs and X-ray technique control. Integrated high-resolution flat panel display monitors directly mounted on the clinican with a precise angle for visualization of live fluoroscopy images of the patient's anatomy. This visualization helps to localize reqions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless fluoroscopic footswitch operation allows for optimum positioning for the surgeon by removing the cable on the floor. The optional interface panel of the Ziehm Vision FD provides connection of peripheral devices such as external monitors, thermal video printers, and image storage devices (USB, DVD) and Dice and wireless network interfaces.
The proposed modified Ziehm Vision FD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehn Vision FD (K240020). Software architecture design is substantially equivalent to that of the predicate Ziehm Vision FD.
The provided FDA 510(k) summary does not contain detailed information regarding acceptance criteria or a specific study proving the device meets those criteria in the typical format of a clinical trial or performance evaluation with specific metrics. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Ziehm Vision FD K240020) by highlighting updates in software and detector technology.
However, based on the text, we can infer some general acceptance criteria and the types of studies/testing performed to support the device's performance.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Summary from provided text) |
|---|---|
| Image Quality Performance | - Image comparison between optimized system settings (including 2k imaging chain) of the modified device shows that the image quality is better or at least all images show more detectability and are sharper than corresponding reference images. |
| - "From a radiological point of view, the image quality of the presented images that were acquired fulfill the requirements as stated by the intended use." | |
| - For pediatric dose settings: "image quality may be reduced due to physical factors, but sufficient image quality is still provided to support the physician during the whole clinical procedure." | |
| Compliance with Federal Performance Standards | - Complies with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment. |
| Compliance with Safety Standards | - Complies with ANSI AAMI ES60601-1-2:2020, IEC 60601-1-3:2021, IEC 60601-2-43:2022, and IEC 60601-2-54:2022. |
| System and Imaging Performance (Non-Clinical) | - Performance bench testing demonstrated system and imaging performance, including physical characteristics, operational and exposure characteristics, and safety features. |
| Software Performance | - Verification and Validation testing successfully conducted. |
| Cybersecurity Posture | - Vulnerability scanning (SBOMs, Tenable Nessus) findings assessed and found acceptable. |
| - Two separate penetration tests displayed a "good cybersecurity posture." | |
| - Static code analysis indicated some code locations that might benefit from adaptation but no stability nor any security issue could be identified that would require immediate action. | |
| Substantial Equivalence | - Risk control assessment, verification activities, and system functionality are consistent with user needs and intended use, and performs as designed, raising no new questions regarding safety or effectiveness. - Device is considered substantially equivalent to the predicate device (Ziehm Vision FD K240020) based on shared design, technology, functionality, and indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set of images or patients. It mentions "anthropomorphic as well as motion-induced phantoms" for image quality testing and "anthropomorphic phantoms" for pediatric dose testing. This suggests the tests were performed on a set of phantom images, not human patient data in the context of specific image count.
- Data Provenance: The testing was performed using phantoms, which are simulated patient data. The origin of the phantoms (e.g., specific manufacturer or dataset) is not explicitly stated. The tests are non-clinical, implying they were conducted in a controlled environment, likely at the manufacturer's facility in Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- The document implies an expert evaluation for image quality: "From a radiological point of view the image quality of the presented images that were acquired fulfill the requirements as stated by the intended use."
- However, it does not specify the number of experts used, nor their specific qualifications (e.g., X years of experience, specific board certifications).
4. Adjudication Method for the Test Set
- The document does not specify an adjudication method (e.g., 2+1, 3+1). The statement regarding image quality being acceptable "from a radiological point of view" suggests a qualitative assessment, but the process is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is an image-intensified fluoroscopic X-Ray system, and the submission focuses on hardware and software updates related to image acquisition and processing ("QuantumStream" and "Image Insights" overlay), not an AI-assisted diagnostic tool that would typically involve human reader improvement metrics.
- The text does not refer to "AI assistance" in the context of improving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This evaluation is on an X-ray imaging system, not a standalone algorithm. The device's performance is inherently tied to the images it produces. The image quality tests described ("better or at least all images show more detectability and are sharper") are a form of standalone performance evaluation of the system's output, comparing it to a reference.
7. The Type of Ground Truth Used
- For image quality testing, the "ground truth" was established by comparing the images produced by the modified device to "corresponding reference images" from the predicate system, and evaluating them against general "radiological requirements" and criteria like "detectability" and "sharpness." Phantoms were used to generate these images.
- For compliance, the ground truth was regulatory standards (21 CFR 1020.30-32 to 21 CFR 892.1650, ANSI/IEC safety standards) and specific guidance documents (e.g., "Guidance for submission of 510(k)s for Solid State X-Ray Imaging Devices").
- For cybersecurity, ground truth involved identifying vulnerabilities and assessing the security posture through established security testing methodologies.
8. The Sample Size for the Training Set
- The document does not mention a traditional "training set" in the context of machine learning, as the update primarily involves a software update to an imaging chain and a new display overlay ("QuantumStream" and "Image Insights") rather than a new AI algorithm that would typically require a large training dataset for development. The "optimized system settings" likely refer to engineering adjustments and calibration rather than algorithm training.
9. How the Ground Truth for the Training Set Was Established
- As no "training set" (in the machine learning sense) is explicitly mentioned, the establishment of ground truth for such a set is not described. The improvements are described as arising from an updated 2k imaging chain.
§ 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.