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The Ziehm Vision FD is intended to provide pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. Is intended for use in visualizing complex anatomical structures and procedures such as, vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in image geometry is required. At the discretion of a physician the device may be used for other imaging applications.

The ZIEHM VISION FD has two main units; Mobile Stand and Monitor Cart workstation. The Mobile Stand C-arm consists of a high frequency generator, X-ray Tube assembly, Solid State X-Ray Imager / Flat Panel Detector, user touch control interface, C-Profile supporting the generator and Solid State X-ray Imager (SSXI), and Integrated Laser light localizers in the image receptor. The Mobile Stand C-profile provides fixed distance mounting of the generator and image receptor allowing the user rotational and linear movements for positioning the c-arm at various angles and distances for visualization of patient's anatomical structures.

The monitor cart workstation supports dual flat panel LCD display monitors, Vision II digital image memory device, imaging capture, image processing, and VisionCenter touch control user interface. External Video connection is provided with RS-170 video timing for domestic market, CCIR for International markets. The Vision FD also provides optional peripheral connections for such devices as video printers, DICOM 3 and external media storage devices.

This 510(k) summary does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria.

The document is a submission for a 510(k) premarket notification for the "Zichm Vision FD Digital Mobile Imaging System." It focuses on establishing substantial equivalence to a predicate device (Ziehm Vision), providing device descriptions, indications for use, and compliance with applicable standards.

Specifically, the following information is missing from the provided text:

• A table of acceptance criteria and the reported device performance: This document does not include any specific performance metrics or acceptance criteria related to image quality, accuracy, sensitivity, specificity, or any other quantifiable measure beyond stating the device's intended use for "higher accuracy in image geometry."
• Sample size used for the test set and the data provenance: There is no mention of any test set, patient data, or its provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set is described, there's no information about ground truth establishment or experts.
• Adjudication method for the test set: Not applicable since no test set is described.
• 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: This is not an AI-assisted device; it's a mobile imaging system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's submission and is not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for a fluoroscopic imaging system.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is described.
• The sample size for the training set: There is no mention of a training set as this is not an AI/machine learning device.
• How the ground truth for the training set was established: Not applicable.

The document primarily focuses on regulatory compliance, product description, and claiming substantial equivalence to an existing device (K011292) based on its intended use and general performance characteristics rather than providing a detailed performance study with specific acceptance criteria.

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