(77 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, 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 Xray imaging, surgery and interventions.
Artis can also support the acquisition of position triggered imaging for spatial data synthesis.
The Artis systems include also the software option DynaCT with following IFU:
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 Modular Angiography systems are specialized angiography systems. In general, they are equipped with C-arm, stand, flat panel detector, x-ray tube, high voltage generator, patient table and image post-processing software.
Siemens currently markets the Artis zee / zeego (K141574) and the Artis Q / Q.zen (K123529). Siemens will provide new software VD11D for both, the Artis zee / zeego and Artis Q / Q.zen systems. The new software VD11D will support the detector Pixium 3040CV (also known as "40HDR") already cleared with Artis Q / Q.zen (K123529). Systems, Artis zee / zeego, and Artis Q / Q.zen use the cleared AEC (Automatic Exposure Control) functionality.
Siemens intends to market new claims specific to the AEC, which are provided in the product claims list. Siemens will replace the cooling unit in both systems.
The Mivabi Angio-CT configuration has been improved and will be known as and marketed as the nexaris Angio-CT configuration. Siemens nexaris Angio-CT configuration was designed to contain both Angio and CT System within close proximity or within the same environment. The CT-gantry on rails will slide towards the Angiography patient table to perform a CT scan without repositioning the patient. After the CT scan, the CT-gantry could be slide away from the patient table to use the table for Angiography C-arm acquisitions.
This 510(k) submission describes modifications made to the previously cleared predicate devices: Artis zee / zeego SW VC21 (K141574) and Artis Q / Q.zen SW Version VD10 (K123529). The modifications will be marketed as "Artis zee / zeego VD11D" and "Artis Q / Q.zen VD11."
The provided document does not contain the detailed acceptance criteria and performance study outcomes typically found in a clinical or standalone performance study report for AI-powered diagnostic devices.
Instead, this document is a 510(k) summary for Siemens Medical Solution USA, Inc.'s Artis zee/zeego & Artis Q/Q.zen angiographic X-ray systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices for hardware and software modifications, rather than evaluating a novel AI algorithm's diagnostic performance against ground truth.
Here's an analysis based on the information provided, highlighting what's present and what's missing:
Acceptance Criteria and Device Performance
- No specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, AUC) are provided for an AI component.
- The document mentions "acceptance criteria" in the context of verification and validation testing for the software specifications and that "all software specifications have met the acceptance criteria," but these criteria are not detailed in terms. This likely refers to system-level tests for functionality, safety, and effectiveness of the updated X-ray system software, not a diagnostic performance metric.
Study Details (as far as can be inferred/is absent)
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A table of acceptance criteria and the reported device performance:
- Absent. There is no table detailing acceptance criteria for diagnostic performance or reported performance metrics like sensitivity, specificity, or F1-score for any AI component. The document discusses regulatory standards compliance and software verification/validation, but not diagnostic accuracy.
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Sample size used for the test set and the data provenance:
- Absent. The document does not describe a test set in the context of diagnostic performance evaluation for an AI algorithm. It refers to "non-clinical test data" and "clinical images and data" used for evaluating the predicate devices, but doesn't specify a test set for the modifications or an AI component.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Absent. No information is provided regarding expert readers or ground truth establishment for a test set, as no diagnostic performance study for an AI algorithm is described.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Absent. Not applicable, as there's no mention of a diagnostic test set for an AI algorithm.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Absent. There is no mention of an MRMC study or any evaluation of human reader improvement with AI assistance. The submission is about modifications to an X-ray imaging system, not an AI diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Absent. No standalone AI algorithm performance study is indicated.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Absent. No ground truth type is specified, as no diagnostic performance study is detailed.
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The sample size for the training set:
- Absent. There is no mention of a training set, indicating that this submission is not for an AI/ML algorithm that requires training. The "DynaCT" software option mentioned is for 3D reconstruction from 2D images, not a learned diagnostic pattern recognition system in the sense of modern AI/ML.
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How the ground truth for the training set was established:
- Absent. Not applicable, as no training set is mentioned.
Summary of What the Document Does Provide:
The document is a 510(k) submission for modifications to existing angiography systems. The modifications primarily involve:
- Revised Indications for Use (clarification, not new uses).
- New software version (VD11D) to support hardware.
- Support for an existing detector (Pixium 3040CV) on an additional system (Artis zee/zeego).
- A new tube cooling unit.
- Updated product claims.
- Configuration updates for the "Miyabi Angio-CT" (now "nexaris Angio-CT"), including improved collision calculation.
The regulatory review concluded that the device is "substantially equivalent" to predicate devices, based on:
- Non-clinical tests for electrical safety, performance, electromagnetic compatibility, and compliance with various international standards (listed in Table 3 on page 10).
- Software verification and validation testing, addressing the FDA's guidance documents for software in medical devices and cybersecurity. These tests demonstrated that the software modifications met acceptance criteria and did not raise new safety or effectiveness issues.
- Human Factors Usability Validation.
Key Missing Information: This document is NOT about an AI-powered diagnostic device in the modern sense that would require performance metrics like sensitivity, specificity, or a comparison against a human expert ground truth. It focuses on demonstrating the safety and effectiveness of updated hardware and software components within an imaging system.
§ 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.