(164 days)
The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediatric populations, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intraoperative 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, 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. 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 near MRI systems.
The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (FPD) and fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator, and the image receptor Flat Panel Detector (FPD). The mobile stand supports the optional wireless footswitch for optimum positioning for the surgeon by removing the cable on the floor. The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, image processing, user controls and image recording devices. Interfaces provided for optional peripheral devices such as external monitors, thermal video printers, wireless video display, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces.
The document provided describes the Ziehm Vision RFD, an image-intensified fluoroscopic X-ray system. The submission (K231692) is for a modified version of a previously cleared device (K203428). The key modification is the addition of a new 12-inch IGZO (Indium gallium zinc oxide) flat panel detector (FPD) to the existing a-Si and CMOS FPD options.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission declares "substantial equivalence" to the predicate device (K203428). This implies that the new device is intended to meet or exceed the performance of the predicate device, especially regarding image quality, safety, and effectiveness. The acceptance criteria are primarily based on established regulatory standards and guidance, with comparative performance against the predicate.
For the new IGZO detector, the performance is reported as an improvement in resolution compared to aSi detectors.
| Feature / Standard | Acceptance Criteria (Implied) | Reported Device Performance (New IGZO FPD) |
|---|---|---|
| Image Quality | Comparable or improved to predicate device (K203428) | IGZO detector has a higher number of pixels and smaller pixel pitch compared to aSi detectors; therefore, the IGZO detector has better resolution compared to aSi detectors. Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality. Radiologist conclusion: image quality of the Ziehm Vision RFD results in a comparable patient care to the Predicate device. |
| Dose Functionality | Ability to reduce dose for certain applications | Assessment regarding the low dose functionality shows the ability to reduce dose for certain applications. Non-clinical dose lab testing was employed. |
| Electrical Safety (ANSI/AAMI ES60601-1) | Compliance with the standard | Test results show compliance. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliance with the standard | Test results show compliance. |
| Radiation Protection (IEC 60601-1-3) | Compliance with the standard | Performed and complies. |
| X-ray Fluoroscopic Equipment Standards (21 CFR 1020.30-32) | Compliance with the federal performance standards | Performance testing confirmed compliance. |
| Solid State X-ray Imaging Devices (Guidance for 510(k) Submissions) | Compliance with the guidance | Documentation demonstrates compliance. |
| Safety and Effectiveness | Substantial equivalence to predicate device (K203428) | The modified device's image quality, safety, and effectiveness supports a determination of substantial equivalence. |
| Digital Radiography (Snapshot) / Operating Values | Identical to predicate device | Identical. |
| Collimator System | Same as already introduced CMOS FPD (for IGZO) | The collimator system of the IGZO is the same as the already introduced CMOS FPD. |
| Anti-scatter Grid | Slightly different values acceptable for IGZO while maintaining safety | The grid of the new IGZO has slightly different values compared to the anti-scatter grids for the other two FPD's (aSi, CMOS) but does not impact safety/effectiveness significantly. |
2. Sample Sizes used for the test set and data provenance
The document states: "Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality." and "Anatomical simulation phantoms were employed, image comparison sets taken were representative of both the adult and pediatric populations."
- Sample Size for Test Set: Not explicitly stated regarding the number of images or cases. It mentions "sets of images" and "anatomical simulation phantoms."
- Data Provenance: "Non-clinical image and dose Lab testing." The country of origin for the data is not specified. It appears to be prospective data generated specifically for this submission through lab testing on phantoms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states: "A Radiologist performed an assessment of individual image sets. Radiologist conclusion, the image quality of the Ziehm Vision RFD results in a comparable patient care to the Predicate device Ziehm Vision RFD (K203428) and fulfils the requirements as stated by the intended use."
- Number of Experts: "A Radiologist" (singular).
- Qualifications of Experts: Assumed to be a qualified radiologist, but specific years of experience or specialization are not detailed.
4. Adjudication method for the test set
The document mentions "A Radiologist performed an assessment" and provided a "conclusion." It does not specify any formal adjudication method like 2+1 or 3+1. It appears to be a single-reader assessment.
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
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to AI or human reader improvement with AI assistance. The device is an X-ray system, and the study focuses on the image quality and performance compared to a predicate device, not on diagnostic aids or AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to an X-ray imaging system, not an algorithm. The assessment described in the document is about the physical device's performance (image quality, dose, safety) as a standalone imaging system.
7. The type of ground truth used
The "ground truth" for image quality assessment was established through:
- Expert Consensus / Assessment: A radiologist's assessment of image sets.
- Performance Metrics: Objective measurements such as DQE, MTF, pixel size, and system resolution (Nyquist) for the detectors.
- Phantom Studies: Use of anatomical simulation phantoms.
- Compliance with Standards: Meeting criteria defined by various IEC, ANSI, and 21 CFR standards.
8. The sample size for the training set
The document does not mention a "training set" as this device is an X-ray system and not an AI/ML algorithm that requires training data in the typical sense. The development and verification processes involve extensive testing and compliance with standards, but not a distinct "training set" for an algorithm.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of an AI/ML device, this question is not applicable based on the provided text. The device is a hardware X-ray system with integrated software for image acquisition and processing.
§ 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.