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AXIOM Artis U is an angiography system developed for diagnostic imaging and interventional procedures. Procedures that can be performed with the AXIOM Artis U include cardiac angiography, neuro-angiography, general angiography, operating room angiography, multipurpose angiography and radiographic/fluoroscopic procedures eg. Gastro-intestinal imaging, Skeletal imaging etc.

The AXIOM Artis U Angiography System is designed of components used from existing The RATOM Artis O Angloguphy Systems (i.e., AXIOM Iconos R200, Powermobil, AXIOM Artis FC). AXIOM Artis U covers the complete range of angiographic applications which are ATTOM Tamber with commercially available Siemens Angiography systems. AXIOM Artis U system consists of a mobil C-arm upon connected with other components (i.e. generator, x-ray tube, collimator, image intensifier, television system, digital imaging system, etc). Many of the components used in AXIOM Artis U are either digital maging system, cool many of include minor modifications to conniciently a venuelo with a mobile C-arm which allows manual angulations and movements. The vertical lift is the only motorized movement.

The provided text is a 510(k) summary for the AXIOM Artis U angiography system, submitted by Siemens Medical Systems, Inc. It establishes substantial equivalence to existing predicate devices without presenting new performance data or a specific study. Therefore, the document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established from a study proving the device meets acceptance criteria.

The information below reflects what could not be extracted from the provided text.

Acceptance Criteria and Device Performance Study Information

The provided 510(k) summary for the AXIOM Artis U angiography system focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a study with specific acceptance criteria and performance data for the device itself. The document states that the AXIOM Artis U is "designed of components used from existing ATOM Artis O Angloguphy Systems" and that "many of the components used in AXIOM Artis U are either commercially available with Mary OF are systems or include minor modifications to existing components."

Therefore, the submission does not include a detailed study with acceptance criteria and reported device performance metrics in the format requested. The claim of substantial equivalence is based on the system's intended use, technological characteristics (being composed of existing, cleared components), and comparison to predicate devices, rather than new clinical performance data.

Here's a breakdown of why each requested point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The 510(k) relies on the performance of its predicate devices, not new performance data for the AXIOM Artis U.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set data is provided for the AXIOM Artis U.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as no test set data requiring ground truth establishment is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set data requiring adjudication is presented.
5. 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: An MRMC study was not performed or referenced in this document. The device is an angiography system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as the device is an imaging system and not designed for standalone algorithmic performance in the context of diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no new performance study data requiring ground truth is presented for the AXIOM Artis U.
8. The sample size for the training set: Not applicable, as there is no mention of a training set or machine learning components.
9. How the ground truth for the training set was established: Not applicable, as there is no mention of a training set.

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