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The Anatom 1000 system is intended to be used as a diagnostic x-ray device, for the purpose of obtaining cross-sectional images of the whole body by computer reconstruction of X-ray data, from the same axial plane taken at different angles.

This device includes signal analysis and display equipment, patient and equipment supports, component parts and accessories. Additionally, the Anatom 1000 system can be field upgraded to either an "A" system or an "HA+" system which includes the capabilities of Helical Scanning (Volumetric scanning) and MPR (Multi-planar Reconstruction).

As evident from the enclosed device description, Anatom 1000 is a stand-alone device. It is intended that the system will be operated under the control of qualified clinicians only, while a patient is being examined. The operators should be healthcare professionals familiar with and responsible for the CT studies to be performed. All of the system's X-ray components are certified to be in compliance with the Federal Diagnostic X-ray Equipment Performance Standard. The enclosed device labeling and instructions provide the operator(s) with the knowledge required to safely use the Anatom 1000 system.

The provided text for device K774455, the Anatom 1000, does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets them.

The document is a 510(k) clearance letter from the FDA, and a summary provided by the manufacturer. These documents primarily focus on:

• Safety: Stating that the device is safe based on compliance with regulations (FDA GMPs, UL2601, CSA 22.2 No. 601.1, IEC 601-1), existing industry practices, and an assessment that it doesn't introduce additional risk compared to conventional CT imaging. It also mentions self-tests and image quality tests.
• Effectiveness: Asserting that the device will perform according to development objectives and is "state-of-the-art technology and, therefore, is equivalent to other similar products already cleared by the 510(k) process." This is a claim of substantial equivalence, not a detailed performance study.
• Indications for Use: Defining its purpose as a diagnostic X-ray device for obtaining cross-sectional images.

Therefore, I cannot populate the requested table and answer the specific study-related questions (sample size, experts, adjudication, MRMC, standalone, ground truth, training set) because that information is not present in the provided text.

The document is a regulatory approval, not a scientific publication detailing performance studies. For that kind of information, one would typically need to refer to a clinical study report or a technical performance assessment, which are not included here.

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