(111 days)
The Ziehm Solo FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging.
The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures.
The visualization of such anatomical structures assists the clinical outcome. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use in any MRI environments.
Ziehm Solo FD uses X-ray imaging technology to visualize the human anatomy. The X-ray tube in the generator produces X-rays that penetrate the patient and then hit a special detector that converts them into digital images. This is done under the user and at the direction of a physician who determines the specific clinical procedure. This visualization assists the physician in localizing pathological areas or during surgical procedures. The image acquisition as well as visualization of in vivo surgical procedures and post-operative results.
The Ziehm Solo FD consist of one mobile Stand. Optionally the device can be ordered with a Viewing Station (Monitor Cart). The Mobile Stand incorporates a small compact design making the C-arm in relation to the patient easier for the operator. The generator with X-ray tube, advanced heat management system, X-ray control and collimators are assembled in one housing in a mono-block generator. The system control is handled via CAN BUS control system.
The mechanical C-Profile supports the flat panel detector and an integrated laser positioning device. The optional available Viewing Station (Monitor Cart) provides a remote touch Solo Center that duplicates the touch Solo Center mounted on the Mobile Stand.
This FDA 510(k) summary describes the Ziehm Solo FD, an image-intensified fluoroscopic X-ray system. The submission mainly focuses on a software update (version 7.10.0) that incorporates the 2k imaging chain "QuantumStream" and a new "Image Insights" overlay, along with the introduction of a new 12-inch IGZO flat panel detector in addition to the existing 8-inch IGZO panel.
Here's an analysis of the acceptance criteria and supporting study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Image Quality: Visualization of anatomical structures sufficient for diagnostic, interventional, and surgical procedures. | Better or at least equal image quality compared to the predicate system. Almost all images generated by the test device (with 2k imaging chain and 12-inch detector) show more details, improved detectability, and are sharper than corresponding reference images. "From a radiological point of view the image quality of the presented images that were acquired fulfil the requirements as stated by the intended use." |
| Compliance with Federal Performance Standards for X-Ray Fluoroscopic equipment: Adherence to 21 CFR 1020.30-32. | The modified Ziehm Solo FD complies with 21 CFR 1020.30-32. |
| Compliance with Safety Standards: Adherence to relevant safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-43, IEC 60601-2-54). | The modified Ziehm Solo FD complies with relevant safety standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-43 and IEC 60601-2-54. |
| Software and Cybersecurity: Adherence to FDA guidance documents ("Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions"). | Cybersecurity testing was performed (vulnerability scanning, penetration testing, static code analysis). Findings were assessed and found acceptable. Two separate penetration tests displayed a good cybersecurity posture. Static code analysis indicated potential areas for improvement but no stability or security issues requiring immediate action. Overall, testing activities demonstrate a good level of cybersecurity, complying with FDA requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a number of patients or images. The study used "anthropomorphic as well as motion-induced phantoms." "Anthropomorphic phantoms so-called 'sectional phantoms' were used and are constructed with a natural human skeleton cast inside a proprietary urethane material that has the same number as the body's soft tissue."
- Data Provenance: The study was conducted using phantoms, not human patient data. Therefore, the concept of country of origin or retrospective/prospective does not directly apply in the usual sense for clinical data. This appears to be lab-based testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: The evaluation included a "radiological point of view," implying evaluation by radiologists, but specific qualifications (e.g., years of experience, board certification) are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The text mentions "The image comparison... shows that the image quality acquired with the test device is better or at least equal." This suggests a comparative assessment, but the method of consensus or individual expert judgment is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned or indicated. The study focused on technical image quality comparison using phantoms. The "Image Insights" overlay is mentioned but no study on its impact on human reader performance is detailed.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Study: This isn't strictly an AI algorithm-only standalone study in the sense of predictive or diagnostic performance. Instead, it's a standalone technical performance study of the updated imaging system (including hardware and software components). The "2k imaging chain 'QuantumStream'" and "Image Insights" overlay are software features that are part of the device's overall technical performance, and their contribution to image quality was assessed. The cybersecurity testing is also a standalone evaluation of the software's robustness.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Ground Truth Type: For image quality, the ground truth was based on a comparative assessment against images from the predicate device and a radiological evaluation of whether the images "fulfil the requirements as stated by the intended use." For compliance (safety and performance standards), the ground truth was demonstrably meeting the specified requirements. For cybersecurity, the ground truth was the identification and assessment of vulnerabilities against established security best practices.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable or not provided. This submission describes modifications to a fluoroscopic X-ray system and its imaging chain, not a machine learning model that would typically require a distinct training set for its core function. While software updates are involved, the description doesn't indicate a new AI model being trained for diagnostic purposes in this context.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable as no distinct training set for a machine learning model is described.
§ 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.