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510(k) Data Aggregation
(170 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 X-ray 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 soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.
The new ARTIS icono (VE2) 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 (VE2) 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 (VE2), 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 C-arm, stand, flat panel detector, x-ray tube, collimator, high voltage generator, patient table, and image post processing.
The ARTIS icono (VE2) covers the complete range of angiographic applications, cardiac angiography, neuro-angiography, general angiography, surgery and surgical angiography, and radiographic/fluoroscopic procedures.
The provided text describes the Siemens ARTIS icono (VE2) angiography system, which is a medical imaging device used for diagnostic and interventional procedures. The document is a 510(k) summary submitted to the FDA to demonstrate substantial equivalence to previously cleared devices.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document details numerous product claims (Table 3), which serve as acceptance criteria for specific features and performance aspects of the ARTIS icono (VE2). The "Comparison Results" in Table 5 also refer to specific testing (Bench Testing, System Validation testing) supporting these claims.
| Acceptance Criteria (from Table 3: Product Claims) | Reported Device Performance / Supporting Evidence |
|---|---|
| Lateral Plane Switch: Preferred cardiology and neuroradiology lateral plane setup can be reached by an automated drive in less than 90 sec. | "Modified: This feature is modified from the previously cleared Primary Predicate Device. All software changes are supported with Bench Testing provided in Section 19. System Validation testing is provided in Appendix K Attachments1-8" (Table 5) (Implied: Meets '< 90 sec' claim) |
| Lateral Plane Switch: Reduced scattered radiation dose to the user by positioning the tube opposite to the user. | "Modified: This feature is modified from the previously cleared Primary Predicate Device. All software changes are supported with Bench Testing provided in Section 19. System Validation testing is provided in Appendix K Attachments1-8" (Table 5) (Implied: Achieves dose reduction) |
| Multiaxis floor stand: 7% faster movement from head to left side/right side (13 sec from head to left side). | Not explicitly stated in a dedicated performance row, but overall modifications are supported by "Bench Testing provided in Section 19 and System Validation testing is provided in Appendix K Attachment 1-8" (Table 5). (Implied: Achieves '7% faster movement' and '13 sec' claims) |
| syngo Dyna3D High Speed: 122% faster c-arm angulation for 3D, 100 degrees per sec instead of 45 degrees. | Not explicitly stated in a dedicated performance row, but overall modifications are supported by "Bench Testing provided in Section 19. System Validation testing is provided in Appendix K Attachments, 1-8" (Table 5). (Implied: Achieves '122% faster' and '100 degrees/sec' claims) |
| Roadmap improvements: Roadmap creation time reduced by 50%. | "Modified: This feature is modified from the Primary Predicate Device. All software changes are supported with Bench Testing provided in Section 19 and System Validation testing is provided in Appendix K Attachment 1-8" (Table 5). (Implied: Achieves '50% reduction' claim) |
| syngo DynaCT Sine Spin: Helps interventionalists visualize bleedings in the interventional suite with a soft tissue resolution of 5 HU (@ 10 mm), respectively 10 HU (@ 5 mm), even in the basal part of the brain and close to the skull. | "Modified: This feature is modified from the previously cleared syngo DynaCT in the Primary Predicate Device. All software changes are supported with Bench Testing provided in Section 19. System Validation testing is provided in Appendix K Attachment 1-8" (Table 5). (Implied: Achieves specified soft tissue resolution) |
| syngo DynaCT Sine Spin: Reducing cone beam CT artifacts in the basal part of the brain and close to the skull. | "Modified: This feature is modified from the previously cleared syngo DynaCT in the Primary Predicate Device. All software changes are supported with Bench Testing provided in Section 19. System Validation testing is provided in Appendix K Attachment 1-8" (Table 5). (Implied: Achieves artifact reduction) |
| Favorites in Toolbars in control room: Image-type specific controls allow for 66% less clicks (1 click instead of 3). | "Modified: This feature is modified from the previously cleared Primary Predicate Device. All software changes are supported with Bench Testing provided in Section 19. System Validation testing is provided in Appendix K Attachments1-8" (Table 5). (Implied: Achieves '66% less clicks' claim) |
| Case Flow: Save 1 min, 64% shorter time (33 sec instead of 90 sec) during a Femoral Access Case Flow. | "Modified: This feature is modified from the previously cleared Primary Predicate Device. All software changes are supported with Bench Testing provided in Section 19. System Validation testing is provided in Appendix K Attachments1-8" (Table 5). (Implied: Achieves '1 min, 64% shorter time' claim) |
| Case Flow: Save 15 clicks (2 instead of 17) during a Femoral Access Case Flow. | "Modified: This feature is modified from the previously cleared Primary Predicate Device. All software changes are supported with Bench Testing provided in Section 19. System Validation testing is provided in Appendix K Attachments1-8" (Table 5). (Implied: Achieves '15 clicks saved' claim) |
2. Sample Size Used for the Test Set and Data Provenance
The document generally refers to "non-clinical tests," "Bench Testing provided in Section 19," "System Validation testing is provided in Appendix K Attachment 1-8," and "Human Factor Usability Validation."
- Sample Size: The document does not specify the sample size for any test sets used in the performance evaluations.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "product development" as the context for these tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document mentions "clinical use tests with customer report and feedback form" as part of the Human Factor Usability Validation. However, it does not specify:
- The number of experts (customers/users) involved.
- Their qualifications (e.g., radiologist with 10 years of experience).
- How ground truth, if any, was established by these experts for performance claims beyond usability.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for ground truth establishment. The "customer report and feedback form" suggests a qualitative assessment rather than a formal, adjudicated ground truth process for performance metrics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The studies mentioned are primarily non-clinical validation and verification tests, and usability testing. There is no mention of comparing human readers' performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is an angiography system with imaging software options. The "software changes" and "improved algorithms" (e.g., for Roadmap, DynaCT) imply standalone algorithm performance within the system. However, the document does not specifically detail standalone algorithm-only performance studies as distinct from the integrated system validation. The focus is on the integrated functions of the ARTIS icono (VE2) system.
7. The Type of Ground Truth Used
The ground truth for the performance claims (e.g., faster angulation, reduced clicks, improved image quality features like artifact reduction and resolution) appears to be based on:
- Technical specifications/measurements: For claims related to speed, time reduction, and possibly image resolution (e.g., 5 HU @ 10mm).
- System internal metrics: For claims like "increased image quality dose ratio," workflow efficiency ("less clicks," "shorter time"), and "artifact reduced grey value resolution."
- Conformance to standards: The device was certified to comply with various IEC, ISO, and AAMI/ANSI standards (e.g., electrical safety, performance, cybersecurity), which imply testing against predefined criteria.
There is no mention of ground truth established by expert consensus, pathology, or outcomes data in the context of these performance claims.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This information would typically be relevant for machine learning or AI components, which might be embedded in "improved algorithms." However, such details are not disclosed in this summary.
9. How the Ground Truth for the Training Set was Established
Since no training set is mentioned, there is no information on how its ground truth was established.
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