(134 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 anglography, 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 maging 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 icono (VE21) 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 physician can navigate catheters and other devices safely. The ARTIS icono (VE21) system consist 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 manipulate the catheters or other devices during x-ray. X-ray release is table side via a footswitch.
The ARTIS icono (VE21), modular angiography systems are designed as sets of components that may be combined into two different configurations (Biplane or Floor) to provide specialized angiography systems. In general, they are equipped with Carm, stand, flat panel detector, x-ray tube, collimator, high voltage generator, patient table, and image post processing.
The ARTIS icono (VE21) covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical angiography, 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 icono (VE21) system configuration, 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 content in variaous 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 icono (VE21) System is capable of 2D and 3D imaging. The c-arms can be mounted on the floor or for biplane systems on the floor and on the ceiling. Other systems and software syngo Application Software, synqo X Workplace, Sensis, and or third-party systems may also be integrated into the ARTIS icono (VE21) screen configuration. Different screen configurations and layouts are possible in the examination room and in the control room.
The Subject device ARTIS icono with software version VE21 will support the following modifications.
| Software / Hardware changes specific to New System Software VE21 | |
|---|---|
| 1. | Updated system Software from VE20 to VE21 |
| A. Lateral Plane syngo DynaCT (3D with Plane B (Biplane) | |
| B. NOMSIE DSA (IQ) Customization of Contrast in DSA Images | |
| C. Optional New Generator (Polydoros ACX) | |
| 2. | Update 510(k) Information |
The provided document is a 510(k) summary for the Siemens ARTIS icono (VE21) System, a medical device for angiography. It describes the device, its intended use, and its substantial equivalence to a predicate device (ARTIS icono VE20).
However, the document does not contain specific acceptance criteria, reported device performance metrics (numerical data like sensitivity, specificity, accuracy), or details of a study that directly prove the device meets acceptance criteria in the format requested.
It states that "All test results met all acceptance criteria" and mentions "Bench Test Summaries" but does not provide the details of these tests or criteria. It also does not include information about sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or the specific type of ground truth used for performance evaluation on its new features (Lateral Plane syngo DynaCT and NOMSIE DSA).
The document is primarily focused on demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance, by detailing changes and adherence to various safety and performance standards.
Therefore, I cannot populate the table or provide the requested information completely as it is not present in the provided text.
Based on the provided text, here's what can be extracted and what is missing:
Information NOT present in the document for the specific modifications (Lateral Plane syngo DynaCT, NOMSIE DSA (IQ) Customization, Optional New Generator):
- Acceptance Criteria Table: Specific numerical acceptance criteria for the new features (e.g., image quality metrics like contrast-to-noise ratio, spatial resolution, or diagnostic accuracy for DynaCT).
- Reported Device Performance: Specific numerical performance data demonstrating how the device met these criteria for the new features.
- Sample Size for Test Set: Not mentioned for any specific performance evaluations of the new features.
- Data Provenance (country of origin, retrospective/prospective): Not mentioned.
- Number of Experts & Qualifications: Not mentioned for establishing ground truth for any performance evaluations of the new features.
- Adjudication Method: Not mentioned.
- MRMC Comparative Effectiveness Study: No mention of an MRMC study or effect size for AI assistance.
- Standalone Performance Study: The document primarily discusses verification and validation of software and hardware changes, not a standalone performance study with clinical outcomes or diagnostic accuracy for the new features.
- Type of Ground Truth Used (for the new features): Not specified (e.g., gold standard, pathology, clinical outcome, expert consensus).
- Sample Size for Training Set: Not mentioned.
- How Ground Truth for Training Set was Established: Not mentioned.
Information that can be inferred or directly stated from the document (mostly related to general safety and validation, not specific performance metrics of new features):
- Study That "Proves" Device Meets Acceptance Criteria: The document states:
- "Verification and Validation: Software Documentation for a Major Level of Concern software per FDA's Guidance Document... is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on ARTIS icono System software (VE21) during product development."
- "The Risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence."
- "ARTIS icono System software (VE21) was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. The Human Factor Usability Validation showed that Human factors are addressed in the system test according to the operator's manual."
- "Performance tests were conducted to test the functionality of ARTIS icono (VE21) System. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness."
- "The modifications described in this Premarket Notification are supported with verification and validation testing."
Summary Table (with placeholders for missing information):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| New System Software VE21: | |
| 1A. Lateral Plane syngo DynaCT (3D with Plane B): | Specific acceptance criteria not provided |
| 1B. NOMSIE DSA (IQ) Customization of Contrast in DSA Images: | Specific acceptance criteria not provided |
| 1C. Optional New Generator (Polydoros ACX): | Specific acceptance criteria not provided |
| General Software Safety & Cybersecurity: | Conformance to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," "Off-The-Shelf Software Use in Medical Devices," and cybersecurity requirements per IEC 80001-1:2010. |
| Electrical Safety, Performance, EMC: | Compliance with various IEC/AAMI/ISO standards (e.g., AAMI ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2:2014, ISO 14971:2019 etc.) |
§ 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.