(60 days)
ARTIS 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 family include cardiac angiography, neuro-angiography, 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. This does not include projection radiography.
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 Xray imaging, surgery and interventions.
ARTIS can also support the acquisition of position triggered imaging for spatial data synthesis.
The ARTIS family include also the software option DynaCT with following indications for use:
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 pheno (VE2) system is a multi-axis system, specifically designed to meet the growing demands of high-end imaging for interventional radiology, interventional cardiology, minimally invasive and hybrid surgery procedures. The stand allows positioning in angular, orbital, lateral, longitudinal and vertical directions, leveraging the flexible isocenter. The ARTIS pheno (VE2) system is equipped with a robotic multi-axis floor stand, C-arm, flat panel detector, x-ray tube, collimator, high voltage generator, patient table, and image post processing. The ARTIS pheno is partially coated with an optional anti-microbial coating. syngo Application Software is optional, available for the support of dedicated clinical workflows.
The ARTIS pheno (VE2) covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical angiography, multipurpose angiography, rotational angiography and radiographic/ fluoroscopic procedures.
- The following components are configured to create the ARTIS pheno VE2 system: Floor stand with C-arm, X-ray tube assembly and FD
- Patient table
- Display ceiling suspension with displays
- Footswitch for releasing radiation
- Control console for controlling the stand, patient table, collimator and imaging system.
Images and operating elements are displayed on screens. Different display variants are used to visualize image and information content. Panoramic display configurations or large displays can be used, configurable to visualize multiple images and information content in various layouts.
Post processing can be done in the exam room or in the control room that offers monitors as well, with a footswitch location in the exam room or the control room. The ARTIS pheno (VE2) System is capable of 2D and 3D imaging.
Other systems and software syngo Application Software, syngo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS pheno (VE2) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room.
The provided text is a 510(k) summary for the ARTIS pheno (VE2) system, which is an angiography system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a medical device's performance against specific acceptance criteria for a new clinical claim or an AI algorithm.
Therefore, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance as it would for a study proving a device meets a clinical performance claim (e.g., diagnostic accuracy of an AI algorithm). The information provided is about the safety and effectiveness of the updated angiography system in terms of hardware, software modifications, and compliance with general medical device standards.
Specifically, the document lists modifications to the ARTIS pheno (VE2) system, such as improved roadmap features, new marketing terminology, updated user interface, and hardware changes. It states that non-clinical performance testing was conducted to assess functionality and compliance with various electrical, safety, and performance standards. However, it does not present clear, quantifiable acceptance criteria or reported performance results in the format requested for a study proving device performance against specific clinical metrics.
Here's why the requested information cannot be extracted from this document:
- No specific clinical performance metrics: The document discusses improvements like "increased image quality dose ratio" and "Improved Image Quality due to improved algorithm" but without quantifiable acceptance criteria (e.g., "sensitivity > X%", "specificity > Y%", "AUC > Z%") or reported numerical results against such criteria.
- Focus on substantial equivalence: The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. This is different from proving that a device (especially an AI-driven one making a new diagnostic claim) meets specific, pre-defined performance thresholds in a clinical study.
- No mention of AI algorithm performance: While there's talk of "improved algorithms" and "syngo DynaCT Multiphase," the document doesn't define or evaluate an AI algorithm in the way you'd expect for a device making a new AI-based diagnostic claim. It's about overall system improvements, not a groundbreaking AI diagnostic tool.
- Lack of test set details: There's no mention of a specific test set, its sample size, data provenance, or ground truth establishment for clinical performance evaluation of a new function (like an AI algorithm would require).
- No human reader studies: There is no mention of MRMC studies or human-in-the-loop performance evaluations.
- No training set details: Information about a training set for an AI algorithm (sample size, ground truth establishment) is absent.
Therefore, I cannot fulfill your request for the table and study details based on the provided text. The document describes a traditional medical device modification clearance, not a study validating an AI algorithm against specific clinical performance criteria.
§ 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.