(49 days)
The Ziehm Vision R is designed to provide pulsed and continuous fluoroscopic imaging, and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. The design includes features for diagnostic and interventional cardiac imaging procedures, and is also intended for use in visualizing complex anatomical structures and procedures for vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the physician's discretion the device may be used for other imaging applications.
Radiographic film examinations can be made with an accessory cassette device attached to the Image Intensifier.
The Ziehm Vision R has two mobile units: a mobile C-arm stand and a monitor cart/ workstation. The C-arm stand contains the x-ray control, high voltage generator, VisionCenter touch controlusion interface, power subs-systems, and control system. The "C profile" or C-shaped mechanical assembly supports at one end the image intensifier and the other the high voltage generator and lubes hassion assembly. The C-Profile is designed to perform rotational and linear movements that allow the user to position the imaging components at various angles and distances with respect to the prieve
The monitor cart/workstation supports dual flat panel LCD display monitors, integrated Ziehm Vision digital image system, imaging capture, image processing, DICOM 3, and VisionCenter touch vontol user interface. External Video connection is provided with RS-170 video timing for domestic market, CCIR for International markets.
The Ziehm Vision R also provides optional peripheral connections for such devices as video printers, thermal printers, network connections, DICOM 3, and external media storage such as USB, DVD devices. A single auxiliary connection is provided for connection to angiographic injoctor systems with the aim of synchronizing image acquisition of angiographic images during controst media injections.
This 510(k) submission for the Ziehm Vision R Digital Mobile Imaging System is for an X-ray system, not an AI/ML powered device. Typically, 510(k) submissions for such traditional medical devices do not include the detailed performance study information requested for AI/ML devices. Therefore, a direct answer to the prompt's specific requirements (acceptance criteria of an AI model, sample sizes, ground truth establishment, MRMC studies, etc.) cannot be provided from the given text.
The provided text focuses on:
- Substantial Equivalence: Comparing the Ziehm Vision R to previously cleared predicate devices (Ziehm Vision K011292, OEC 9800 Plus K021049, OEC 9800 E/CV K024012). This is the primary method of demonstrating safety and effectiveness for traditional devices in 510(k) submissions.
- Device Description and Intended Use: Outlining what the device is, how it functions, and for what medical purposes it is intended.
- Compliance with Standards: Listing various electrical, radiation safety, and medical device standards the device adheres to.
Therefore, many of the requested fields cannot be filled based on the provided document because they pertain to performance testing protocols specific to AI/ML software, which is not applicable here.
However, to address the prompt as best as possible with the available information, here's a summary of what can be extracted and an explanation of why other requested information is not present:
1. Acceptance Criteria and Reported Device Performance:
For a traditional X-ray system, "acceptance criteria" and "reported device performance" are typically defined by compliance with manufacturing specifications, safety standards, and functional equivalence to predicate devices, rather than AI-specific metrics like AUC or F1 score.
| Acceptance Criteria (Implied by Standards & Equivalence) | Reported Device Performance (Implied) |
|---|---|
| Electrical Safety: Compliance with IEC 60601-1, UL 60601-1. | Meets relevant electrical safety standards. |
| Radiation Safety: Compliance with 21 CFR 1020.30, 1020.31, 1020.32; IEC 60601-1-3. | Meets U.S. federal and international radiation protection standards for diagnostic X-ray equipment. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2. | Operates reliably in standard medical environments without harmful electromagnetic interference. |
| Mechanical Safety & Functionality: Performance similar to predicate mobile C-arms. | Provides pulsed and continuous fluoroscopic imaging and spot film imaging effectively for intended procedures (cardiac, vascular, orthopedic, etc.). |
| Image Quality: Quality comparable to predicate devices. | Produces diagnostic-quality images suitable for its indicated uses. (Specific quantitative metrics are not provided in this summary but would be part of the full submission). |
| Software Safety: Compliance with IEC 60601-1-4. | Programmable electrical medical system functions safely and reliably. |
2. Sample size used for the test set and the data provenance: Not applicable. This device is not an AI/ML algorithm requiring a distinct test set for performance evaluation in the context of this 510(k) summary. Its "performance" is primarily demonstrated through engineering verification and validation against established standards and comparison to predicate devices, not through a clinical test set for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for an AI model's test set is not relevant for this traditional hardware device 510(k) summary.
4. Adjudication method for the test set: Not applicable.
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 device is an X-ray imaging system, not an AI-powered diagnostic aid that would be compared for its impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. The device does not "learn" from a training set in the way an AI/ML model does.
9. How the ground truth for the training set was established: Not applicable.
Summary of what the document does provide regarding "proof of meeting acceptance criteria":
The document argues for substantial equivalence primarily based on:
- Identical Intended Use: The Ziehm Vision R has the same intended use as the predicate devices (K011292, K021049, K024012) for fluoroscopic and spot film imaging during various medical procedures.
- Similar Technological Characteristics: It is a mobile C-arm type X-ray system, including a high-voltage generator, X-ray tubes, image intensifier, monitor cart/workstation with digital imaging capabilities, similar to the predicates.
- Compliance with Recognized Standards: The device was designed to comply with a comprehensive list of national and international standards for medical electrical equipment, radiation safety, electromagnetic compatibility, and software safety (listed in Section 2). These standards themselves embody a set of "acceptance criteria" for safe and effective operation.
The "study" that "proves" the device meets acceptance criteria, in this context, is the demonstration of adherence to these standards and the comparison of its technical specifications and performance to the legally marketed predicate devices, which the FDA found acceptable in their previous clearances. This is the standard pathway for traditional medical device 510(k) clearance, rather than a clinical trial or performance study on an algorithm's output.
§ 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.