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Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Procedures that can be performed with the Artis one include cardiac angiography, neuro-angiography, general angiography, rotational multipurpose bodv angiography, 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 X-ray imaging, surgery and interventions.

The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.

Siemens Medical Solutions USA, Inc. intends to market an angiography x-ray system the Artis one Angiographic System, SW Version VA10. This 510(k) submission describes several modifications to the previously cleared predicate devices the Artis zee/ zeego K122644; Artis Q and Q.Zen- Modular Angiographic System K123529 and the X-LEONARDO Workstation K042995. The following modifications are made to the cleared predicate devices and developed into the Subject Device the Artis one:

1). A modified Flat Panel detector Trixell pixium 2630S; 2). A modified collimator MFD; 3). A modified x-ray tubes assembly MEGALIX Cat Plus 125/40/90-125GW; 4). A modified Software Version VA10; 5). A modified C-Arm stand; 6). A new patient table; 7). A modified imaging processing system; 8). A modified display; 9). Modified user Control Modules; 10). Integrated 3D imaging; 11). Proposed product claims associated with the above device modifications (see Section 13 Labeling).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Artis one Angiographic System:

It's important to note that this 510(k) summary focuses on substantial equivalence to predicate devices rather than independent performance validation against specific acceptance criteria for a new medical AI device. The Artis one is an angiography system, not an AI algorithm in the contemporary sense of the request. Therefore, direct answers to several of your questions regarding AI-specific criteria, such as MRMC studies, standalone algorithm performance, and sample sizes for training/test sets of an AI, are not applicable or not explicitly stated in this document.

The document primarily details modifications to existing, cleared angiography systems and asserts their continued safety and effectiveness through comparison.

Acceptance Criteria and Reported Device Performance (Summary based on the provided text):

Since the device is an angiography system and not a new diagnostic AI, the "acceptance criteria" are framed around maintaining safety and effectiveness, and achieving diagnostic image quality comparable to predicate devices.

• Risk analysis completed, hazards mitigated.
• No adverse effects or complications observed during studies.
• Conforms to EMC/electrical safety standards. |
  | Effectiveness / Performance | - "Image quality has been considered of diagnostic quality and adequate for guidance during interventional procedures" (from Clinical Use Test).
• Software specifications met acceptance criteria (from software testing).
• Functionally comparable to predicate devices. |
  | Substantial Equivalence | - Indication for use is the same as predicate device (Artis zee/zeego K122644).
• Technological characteristics are the same.
• Post-processing and 3D imaging substantially equivalent to predicate systems. |

Study Information Pertaining to the Artis one Angiographic System:

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Clinical Use Test): The document mentions "normal and obese adult patients" were part of a "Clinical Use Test," but does not specify the sample size (number of patients).
   • Data Provenance: Not explicitly stated, but given Siemens Medical Solutions USA, Inc. is the importer/distributor in Malvern, PA, and the manufacturing site is in Shenzhen, China, the data's country of origin is not specified. The study was "retrospective" or "prospective" is also not stated. The test is described as a "Clinical Use Test," implying prospective collection for the purpose of the test.
   • Bench Test (Concurrent Study): Phantom images were used for a "Concurrent Study" (bench test). No sample size (number of phantom images) specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided as the evaluation appears to be a general assessment of "diagnostic quality" by implied clinical users rather than a specific ground truth labeling task for an AI. The document states "the operators are health care professionals familiar with and responsible for the evaluating and post processing of X-ray images."

3. Adjudication method for the test set:

   • Not explicitly stated. Given the nature of a "Clinical Use Test" for an angiography system, it's likely that a consensus of clinicians or their individual assessments during use determined diagnostic quality, but no formal adjudication method (like 2+1) is described.

4. 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:

   • No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI algorithms on human reader performance, which is not the focus of this 510(k) for an updated angiography system.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. The Artis one is an angiography system, not a standalone AI algorithm. Its performance is intrinsically tied to human operation and interpretation.

6. The type of ground truth used:

   • For the "Clinical Use Test," the "ground truth" for effectiveness was the subjective assessment that "image quality has been considered of diagnostic quality and adequate for guidance during interventional procedures."
   • For the "Concurrent Study" (bench test), it involved phantom images and likely objective measurements against expected performance parameters for an imaging system, not a diagnostic 'ground truth' in the clinical sense.

7. The sample size for the training set:

   • Not applicable. This document describes a traditional medical device (angiography system) clearance, not the development of an AI algorithm that would typically have a distinct training set. The "software version VA10" was developed and tested, but no AI training set is mentioned.

8. How the ground truth for the training set was established:

   • Not applicable. As no AI training set is described, there's no ground truth establishment method for it.

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