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The intended use of the ARTÍSTE MV SA™ linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.

The ACCEL system is the internal name for the Siemens program which includes the ONCOR Linear Accelerator product lines. The newest member of the ACCEL systems is the ARTISTE MV SATM Linear Accelerator product. The ARTÍSTE MV SA™ is composed of upgraded hardware, firmware and software as standard features.

The ARTÍSTE MV SA™ includes an Electronic Portal Imaging Device (EPID), a 160 leaf multi-leaf collimator, and the syngo™ RT Therapist Express Workspace with MVision™.

The syngo™ RT Therapist Express Workspace is a software application that uses syngo™ based applications.

The provided text describes a 510(k) summary for the Siemens ARTISTE MV SA™ linear accelerator system, which is a therapeutic device for cancer treatment. This type of regulatory submission focuses on substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance studies for novel AI/software devices. Therefore, much of the requested information about acceptance criteria, study details, and AI performance metrics is not available in the provided document.

However, I can extract information related to the device description and regulatory aspects:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided 510(k) summary. The document does not describe specific performance metrics or acceptance criteria for the ARTISTE MV SA™. Instead, it asserts substantial equivalence to a predicate device based on its intended use and technological characteristics.

2. Sample size used for the test set and the data provenance:

This information is not available. The document does not describe any specific testing with a 'test set' in the context of performance metrics for an AI-like algorithm. The submission is for a linear accelerator, not a diagnostic AI device requiring such testing.

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

This information is not available. The concept of "ground truth" and expert adjudication is typically applicable to diagnostic imaging AI devices, which is not the primary focus of this linear accelerator submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not available. As above, this is relevant for diagnostic AI performance studies, which are not described here.

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:

This information is not available. The ARTISTE MV SA™ is a treatment delivery system, not a diagnostic AI device that would typically involve human readers. While it includes "MVision™ (Cone Beam acquisition and reconstruction and the Adaptive Targeting application)," the document does not present it as a standalone diagnostic AI for interpretation by human readers requiring an MRMC study.

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

This information is not explicitly detailed as a separate performance study. The document states that the syngo™ RT Therapist Express Workspace, which includes MVision™, is a software application. However, it does not provide a standalone performance study report for these embedded features in isolation from the overall linear accelerator system's function. The focus is on the device as a whole for therapeutic treatment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not applicable/available in the context of the provided 510(k) summary for a linear accelerator. The "ground truth" for a therapeutic device would generally relate to the accuracy of radiation delivery and treatment effectiveness, which are assessed through different means than expert consensus on images.

8. The sample size for the training set:

This information is not available. As a medical device for therapeutic purpose, the submission focuses on hardware and software equivalence, not on AI model training data.

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

This information is not available. This concept is relevant for AI model development, which is not the focus of this 510(k) submission.

Summary based on the provided text:

The provided document is a 510(k) summary for a linear accelerator (ARTISTE MV SA™). The purpose of a 510(k) is to demonstrate substantial equivalence to a predicate device, not to present extensive performance criteria and studies akin to those required for novel AI-powered diagnostic tools. Therefore, the document largely focuses on device description, intended use, and comparison to the predicate device (ONCOR EXPRESSION with COHERENCE Workspaces, K060226) without delving into the detailed performance metrics of specific software algorithms (like MVision™) that would typically involve the requested information. The FDA's letter confirms substantial equivalence, allowing the device to proceed to market under general controls.

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