(138 days)
The Ziehm Solo is intended to provide contactless fluoroscopy Imaging, capturing, temporarily storing, and display of non-invasive x-ray imaging of the patient using pulsed and continuous fluoroscopy, during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room fluoroscopy procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. This device does not support and is not intended for use in performing mammographic imaging.
The Ziehm Solo Mobile Stand incorporates a single arm monitor assembly providing a more adaptable positioning of the display monintors to the clinician and the C-arm in relation to the patient. The C-profile provides fixed distance mounting of the generator and Image Intensifier and manual rotation around a non iso-centric location. The mobile stand allows the manual rotational and linear movements of the C-arm with a motorized vertical movement for positioning the c-arm at various angles and distances for visualization of patient's anatomical structures. Optional 120kV and or 20mA Fluoro operations are available. The 2.02 kW high frequency generator incorporates a single focus fixed anode x-ray tube, and high voltage generator is a single mono-block generator tube housing assembly. The virtual collimator and x-ray control mount to the generator housing assemble and provides pulsed and continuous fluoroscopy operations including a special digital radiography (snapshot) mode. The SoloCenter is a centralized touch screen providing the user/operator with a graphical user Interface including the x-ray control panel. The Ziehm Solo does not have a conventional Monitor Cart, the workstation consists of a mechanical arm assembly supporting a single or dual high-resolution flat panel LCD display monitor(s). Ceiling or wall monitors can be added by means of two external monitor connectors. Other conventional external interfaces are provided on the mobile stand for preipherial devices such as video printers, and storage devices such as USB and DVD.
This document is a 510(k) Summary for the Ziehm Solo, a Digital Mobile C-Arm X-ray system. It outlines the device's description, indications for use, contraindications, technology, user characteristics, and the standards it meets. Importantly, it emphasizes substantial equivalence to a predicate device (ZIEHM VISION2 K073346) based on non-clinical performance test data.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or detailed performance metrics. Instead, it relies on substantial equivalence to a predicate device and compliance with various international and federal standards. The reported "performance" is that the device meets these standards and is equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with 21 CFR 1020.30-32 (Federal Performance Standard for Diagnostic X-ray Systems) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60601-1 (Medical Electrical Equipment, General Requirements for Safety) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60601-1-2 (Medical Electrical Equipment, EMC) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60601-1-3 (Radiation Protection in Diagnostic X-ray Equipment) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60601-1-4 (Programmable electrical medical systems) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60601-2-7 (Safety of HV/X-ray Generators) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60601-2-28 (Safety of X-Ray Source and Tube Assemblies) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60601-2-32 (Safety of Associated X-ray Equipment) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60825-1 (Safety of laser products) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 14971 (Risk Management) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Substantial equivalence to predicate device (ZIEHM VISION2 K073346) | Performs in an equivalent manner to the predicate device and in accordance with its labeling; does not raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify any sample size for a test set in the context of clinical performance or diagnostic accuracy. The evaluation is based on "non-clinical performance test data" and a comparison to a predicate device. The data provenance is not explicitly stated beyond being "non-clinical performance test data" included in the submission. It does not refer to patient data or retrospective/prospective studies in the context of device performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable and not provided in this document. The submission is for a fluoroscopic X-ray system, and its evaluation relies on engineering and regulatory standards compliance, along with substantial equivalence to a predicate device. There is no mention of a diagnostic accuracy study requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. As there is no diagnostic accuracy study described, no adjudication method would be required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
No MRMC comparative effectiveness study is mentioned or implied. The document focuses on the device's technical specifications and substantial equivalence to a predicate, not on improvements in human reader performance with or without AI assistance. This 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:
This information is not applicable and not provided. The Ziehm Solo is a hardware device for X-ray imaging, not a standalone algorithm.
7. The type of ground truth used:
This information is not applicable and not provided. Given the nature of the device and the submission, there is no diagnostic accuracy study described that would require a "ground truth" in the typical sense (e.g., pathology, clinical outcomes). The evaluation focuses on meeting engineering standards and being equivalent to a predicate.
8. The sample size for the training set:
This information is not applicable and not provided. This device is not an AI/ML algorithm that would undergo a training phase with a specific dataset.
9. How the ground truth for the training set was established:
This information is not applicable and not provided. As there is no training set for an AI/ML algorithm, no ground truth establishment method is relevant.
§ 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.