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510(k) Data Aggregation
(144 days)
ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno
ARTIS is a family of dedicated angiography systems developed for single plane 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, neuroanqiography, 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 X-ray imaging, surgery and interventions.
The ARTIS systems can also support the acquisition of position triggered imaging for spatial data synthesis.
The ARTIS systems 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 Family (VE40A) system is a medical device that allows visualization of vessels within the human body. It is of the utmost importance to find the right projections so physicians can navigate catheters and other devices safely. The ARTIS Family (VE40A) consists of a patient table and a multi-axis motorized c-arm that can be positioned around the patient and angulated in a double-oblique fashion iso-centering the region of interest between the x-ray tube and the flat panel detector. The X-ray generator is placed separately. The displays for visualizing the X-ray images are mounted at the ceiling with a movable display suspension system. System operation is executed via control modules table side so that the physician can move and position the table and c-arm adequately for best imaging while manipulating catheters or other devices during the x-ray. X-ray release is tableside via a footswitch.
The ARTIS Family (VE40A) modular angiography systems are designed as sets of components that may be combined into four different confiqurations (Biplane, Floor, Ceiling, or the ARTIS pheno) to provide specialized angiography systems. In general, they are equipped with a C-arm, stand, flat panel detector, x-ray tube, collimator, high voltage generator, patient table, and image post-processing.
The ARTIS Family (VE40A) 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 a Floor or Biplane configuration:
- (1) Floor stand with C-arm, X-ray tube assembly, and FD
- (2) Patient table
- (3) Display ceiling suspension with displays
- (4) Footswitch for releasing radiation
- (5) Control console for controlling the stand, patient table, and imaging system
Images and operating elements are displayed on screens. Depending on the ARTIS Family (VE40A) system configurations, different display variants are used to visualize image and information content. Displays that visualize single images or large displays that are configurable to visualize multiple images and information contained in various layouts are used.
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 Family (VE40A) Systems are capable of 2D and 3D imaging. The c-arms can be mounted on the floor or for biplane systems on the floor, the ceiling or ARTIS pheno. Other systems and software syngo Application Software, syngo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS Family (VE40A) screen configuration.
The provided document is a 510(k) Premarket Notification from Siemens Medical Solutions USA, Inc. for their ARTIS icono (VE40A) and ARTIS pheno (VE40A) angiography systems.
Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of specific acceptance criteria. Instead, it broadly states that "All test results met all acceptance criteria" and that "The testing results show that all the software specifications have met the acceptance criteria."
The performance testing primarily focuses on the safety and functional aspects of the updated software and a new hardware feature (Xpand).
| Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Software Functionality & Validation | Conformance to "Guidance for the Content of Premarket Submissions for Device Software Functions" and "Off-The-Shelf Software Use in Medical Devices" (implied criteria include proper function, no new safety/effectiveness issues, and meeting all software specifications). | All software modifications conform to guidance. All software validation data demonstrates the Subject Device is as safe and effective as the Predicate Device. All test results met all acceptance criteria. |
| XPAND Feature (Hardware/Software) | The C-arm of the ARTIS icono ceiling system should move to specified positions (e.g., transfer, radial access, typical cardiology projection) as intended and acceptably. (Implied: without introducing new safety or effectiveness issues). | Bench tests were conducted and found acceptable and did not raise any new safety or effectiveness issues. These tests "flowed testing the steps the user performed." |
| Electrical Safety, Performance, EMC | Compliance with numerous IEC and ISO standards, including ES60601-1, 60601-1-2, 60601-1-3, 60825-1, TR 60878, 62304, 60601-2-28, 60601-2-43, 60601-2-54, 10993-1, 14971, 15223-1, 17664-2, 60601-2-35, 62366-1, 62563-1, 62563-2, PS 3.1 (DICOM), ANSI UL 2900-1, ANSI UL 2900-2-1, AAMI TIR57, 60601-1-6, AAMI TIR69, USEMCSC C63.27-2021, IEC TR 60601-4-2, and ISO 20417. | The ARTIS Family (VE40A) was certified by Siemens Healthcare GmbH Corporate Testing Laboratory to comply with the listed standards. |
| Overall Safety and Effectiveness | Device is as safe and effective as the predicate devices for its intended use, with no new issues of safety or effectiveness. (General regulatory requirement). | Performance tests were conducted with acceptable results, raising no new safety or effectiveness issues. Non-clinical test results demonstrate that the acceptance criteria are adequate for the intended use. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific "sample size" in terms of patient cases or images for the performance testing. The non-clinical performance testing described seems to be more about functional verification and validation of the software and hardware modifications rather than a study on a diagnostic dataset.
- Test Set Sample Size: Not specified. The description "XPAND - Ceiling Transversal Flow testing the steps the user performed to move the C-arm" suggests a functional test of the system's mechanics and software, likely involving engineers or test personnel, rather than a dataset of patient images.
- Data Provenance: The testing was "conducted for the ARTIS Family (VE40A)" by Siemens. It is internal non-clinical testing. No country of origin of patient data or retrospective/prospective nature is mentioned, as it does not appear to involve patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The tests described are functional and verification tests for the software and hardware, not diagnostic performance studies requiring expert ground truth establishment on medical images.
4. Adjudication Method for the Test Set:
Not applicable. This was not a study requiring expert adjudication of medical image interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. The document does not describe the device as incorporating AI, nor does it conduct any studies with human readers. The device is an image-intensified fluoroscopic X-ray system, and the changes are software updates and a mechanical feature.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done:
No, a standalone algorithm performance study was not explicitly described. While "Software functional, verification, and System validation testing were conducted with passing results," these relate to the functionality of the system's operating software and a new mechanical movement feature ("Xpand"), not an AI algorithm's diagnostic performance. The DynaCT (3D reconstruction) is mentioned as a software option, but no specific performance study of DynaCT as a standalone algorithm is detailed in this section of the submission. The changes outlined are updates to the overarching system software (VE30A to VE40A, and VE23 to VE40A).
7. The Type of Ground Truth Used:
For the functional and verification testing:
- Software Functionality: The ground truth would be the defined software specifications and requirements.
- XPAND Feature: The ground truth would be the engineering specifications for C-arm movement and positioning.
- Compliance with Standards: The ground truth is the requirements outlined in the various IEC, ISO, and other recognized standards.
8. The Sample Size for the Training Set:
Not applicable. This device, based on the provided document, does not appear to involve AI/ML technology that requires a training set in the conventional sense of machine learning for diagnostic tasks. The software updates are for the system's operational control and imaging capabilities, not for an algorithm that learns from data to perform a diagnostic function.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no apparent training set for an AI/ML algorithm described in this document.
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