(260 days)
Artis zee / zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Procedures that can be performed with the Artis zee / zeego family include cardiac angiography, neuroangiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions
Artis zee / zeego can also support the acquisition of position triggered imaging for spatial data synthesis.
The Artis zee and Artis zeego include also the software option DynaCT which identifies the Artis as a system with a C-arm CBCT functionality.
DynaCT is an x-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.
DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.
The Artis zee/zeego Modular Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems. A new Flat Panel detector has been added to the systems.
The Artis zee / zeego Modular Angiography System with the new Flat Panel detector is substantially equivalent to the AXIOM Artis Modular Angiography System VC14 with all its components as described in the Device Description, Section 10 and the Substantial Equivalence Section 11.
The provided text is a 510(k) summary for a medical device (Artis zee/zeego with CSX-10 Detector SW VC21), which is a regulatory submission to the FDA. It declares substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, and MRMC studies is not available in this document.
Here's a breakdown of what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the 510(k) summary. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Artis zee, Artis zeego SW VC14, K090745) rather than establishing and reporting against new performance acceptance criteria for the modified device.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. The submission details modifications to an existing system, including a new flat panel detector. It doesn't describe a specific "test set" in the context of clinical performance evaluation for acceptance criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not provided. As no specific study with a "test set" and ground truth establishment is detailed, this is not applicable here.
4. Adjudication Method for the Test Set:
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No MRMC comparative effectiveness study is mentioned. The document primarily focuses on technological characteristics and substantial equivalence, not comparative clinical effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is an angiography system with a new detector, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable in this context. The document describes a medical imaging system that produces images for human interpretation.
7. The Type of Ground Truth Used:
This information is not provided. No specific "ground truth" is described in the context of device performance evaluation. The device is intended to produce images for diagnostic, surgical planning, interventional procedures, and treatment follow-up, implying that the output (images) would be interpreted by healthcare professionals.
8. The Sample Size for the Training Set:
This information is not provided. The device is an imaging system, not an AI system that undergoes "training."
9. How the Ground Truth for the Training Set Was Established:
This information is not provided. This concept is not applicable to the type of device described.
Summary of Information from the Provided Text:
The document is a 510(k) submission, specifically a "510(k) Summary," which aims to demonstrate that a modified device (Artis zee/zeego with CSX-10 Detector SW VC21) is "substantially equivalent" to a legally marketed predicate device (Artis zee, Artis zeego SW VC14).
- Device Name: Artis zee/zeego with CSX-10 Detector SW VC21
- Predicate Device: Artis zee, Artis zeego SW VC14 (K090745, cleared June 18, 2009)
- Basis for Equivalence: The document states that the new device is a modification of the predicate device, primarily adding a new Flat Panel detector. It asserts that the functionality and indications for use are similar.
- Safety and Effectiveness Concerns: Siemens states that instructions for use are included, risk management is ensured via hazard analysis and V&V testing, and adherence to recognized industry practices minimizes electrical, mechanical, and radiation hazards. Operators are expected to be healthcare professionals.
- Conclusion: Siemens states that the Artis zee/zeego Modular Angiography System with the new detector is substantially equivalent to the predicate device because it has the same indication for use and similar functionality.
The 510(k) process typically relies on demonstrating equivalence to an already cleared device, potentially through performance differences that do not raise new questions of safety and effectiveness, rather than a detailed study against specific, novel acceptance criteria as might be expected for entirely new technology or PMA submissions.
§ 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.