(58 days)
The ZIEHM VARIO and ZIEHM VARIO 3-D C-arms provide fluoroscopic and spot film imaging of the patient during diagnostic, Interventional and surgical procedures. It is intended to be used whenever the Clinician benefits from Iso-centric positioning and/or intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures such as cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities. The design includes features intended for performing vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures. At the discretion of a physician 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 VARIO 3D 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, image intensifier, and user. touch control interface, C-Profile supporting the generator and image intensifier 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 in addition the device has variable ISO Centric operation, and integrated Iso-centric operations for performing 3D imaging. The monitor cart workstation supports dual flat panel LCD display monitors, digital image memory device, imaging capture, image processing, and touch control user interface. External Video connection is provided with RS-170 video timing for domestic market, CCIR for International markets. The ZIEHM VARIO 3D also provides optional peripheral connections for such devices as video printers, DICOM 3, CAS connection for image guided surgery and external media storage devices.
The Ziehm VARIO and Ziehm VARIO 3D C-arms are fluoroscopic and spot film imaging devices. The provided text does not contain information about specific acceptance criteria or a study that evaluates the device's performance against such criteria. Instead, it focuses on substantial equivalence to predicate devices and compliance with general safety and performance standards for x-ray systems.
Therefore, I cannot populate the table or provide details for most of the requested points based on the given document.
Here's a summary of what can be inferred from the provided text, along with what cannot be answered:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document describes substantial equivalence to predicate devices and compliance with standards, not performance against specific clinical test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. No specific test set or ground truth establishment is mentioned for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No specific test set or adjudication method is mentioned for performance evaluation.
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:
- No such study was mentioned. The device is an imaging system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device described is an imaging system that requires human operation; it's not an algorithm for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided. No specific ground truth is mentioned for performance evaluation. The substantial equivalence relies on the predicate devices meeting regulatory standards.
8. The sample size for the training set:
- Not applicable/Not provided. This is an imaging device, not a machine learning algorithm requiring a "training set" in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
Summary of available information:
- Device Name: Ziehm Vario 3D Mobile Imaging System
- Intended Use: Fluoroscopic and spot film imaging during diagnostic, interventional, and surgical procedures; for iso-centric positioning and intraoperatively generated 3D imaging of high contrast objects (bones and joints), complex anatomical structures, and joint fractures. Also for vascular, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, and critical care and emergency room procedures.
- Predicate Devices:
- Compliance: The device was designed to comply with applicable portions of various standards and regulations for product safety requirements, including Federal Performance Standard for Diagnostic X-ray Systems (21 CFR 1020.30, 21 CFR 1020.31, 21 CFR 1020.30 - Note: there's a typo in the provided text with 1020.30 listed twice), UL 60601-1, IEC 60601 series, IEC 60825-1, 93/42/EEC Annex 1, and DIN ISO 14971.
- Conclusion: The FDA determined the device is substantially equivalent to the predicate devices and does not raise new questions of safety or effectiveness.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.