(324 days)
ZEN-7000 is a mobile fluoroscopy system is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
ZEN-7000 mobile fluoroscopy system is an image intensified fluoroscopic system consisting of two mobile units: a Mainframe (C-Arm) and a Workstation. The Mainframe (C-Arm) is comprised of a high voltage generator, x-ray control, and a "C" shaped apparatus, which supports an X-ray tube and an image intensifier. The Mainframe is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The Workstation is a mobile platform that supports image display monitors and recording devices.
The document does not describe a clinical study or performance data based on specific acceptance criteria for the device's diagnostic performance, e.g., sensitivity, specificity, or accuracy.
Instead, this 510(k) submission relies on demonstrating substantial equivalence to predicate devices (GENORAY ZEN-7000, K103425, and GE Healthcare Surgery OEC 9900 Elite, K082781) by showing that the new device (GENORAY ZEN-7000, K140041) has similar technological characteristics and indications for use, and complies with relevant safety and performance standards.
The document indicates that the device meets acceptance criteria related to safety and effectiveness standards, not diagnostic accuracy for a specific clinical condition using a test set of patient data.
Here's a breakdown of the information provided, specifically addressing your points where data is available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table for diagnostic performance metrics (e.g., sensitivity, specificity) against specific acceptance criteria. Instead, the acceptance criteria are related to compliance with industry and regulatory standards for safety and performance of X-ray systems.
| Acceptance Criteria Category | Reported Device Performance / Compliance |
|---|---|
| Electrical, Mechanical, Environmental Safety | Complies with IEC 60601-1 Series, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-43, and IEC 60601-2-54. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2. |
| X-ray Imaging Device Guidance | Complies with FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" (though the device is image-intensified, this guidance might overlap with general X-ray imaging). |
| Electronic Product Radiation Control (EPRC) | Meets the EPRC standards (21 CFR 1020.30, 31). |
| Digital Imaging and Communications in Medicine (DICOM) | Meets the provisions of NEMA PS 3.1-3.18, Digital Imaging and Communications in Medicine (DICOM) Set. |
| Quality Management System | New device modifications completed in accordance with GENORAY quality management system design controls. |
| Test Results | "All test results were satisfactory and the result of bench and clinical evaluation indicates that the ZEN-7000 is as safe and effective as the predicate devices." (Note: "clinical evaluation" here likely refers to safety and foundational performance, not a diagnostic accuracy study with patient images). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. The document does not describe a test set of patient cases or images for evaluating diagnostic performance. The evaluation focused on engineering performance and safety compliance.
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. As no diagnostic test set was used, no experts were required to establish ground truth for such a purpose.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No diagnostic test set or adjudication for ground truth of diagnostic findings was used.
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 a Fluoroscopic X-ray system, not an AI-powered diagnostic tool. No MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a hardware imaging device, not an algorithm, and does not operate in a standalone diagnostic capacity separate from human operation and interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable for diagnostic accuracy. The "ground truth" equivalent in this submission relates to established engineering standards, regulatory requirements, and the technical specifications of the predicate devices. For example, a "ground truth" for resolution would be the measurable resolution value achieved, compared against the specified minimums or predicate device values.
8. The sample size for the training set
- Not Applicable. This is an X-ray hardware system, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. As no training set was used, this question is not relevant.
In summary: This 510(k) submission for the GENORAY ZEN-7000 (K140041) focuses on demonstrating substantial equivalence to previously cleared predicate devices through compliance with established safety, electrical, and performance standards relevant to X-ray imaging systems. It does not involve a clinical study to assess diagnostic accuracy or performance metrics using a patient-image test set.
§ 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.