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The SOMATOM Definition AS/ ASt is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

The Siemens SOMATOM Definition AS/ AST is a Computed Tomography X- ray Systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The SOMATOM Definition AS/AS+ system produces CT images in DICOM format, which can be used by postprocessing applications commercially distributed by Siemens and other vendors. The computer system delivered with the CT scanner is able to run such post processing applications optionally.

This 510(k) summary for the SIEMENS SOMATOM Definition AS/AS+ Computed Tomography X-ray System does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on establishing "substantial equivalence" of the new device to existing predicate devices already on the market. It covers:

• Contact Information: Details of the submitting company and regulatory contact.
• Device Name and Classification: Product name, proprietary trade name, classification name, panel, CFR section, device class, and product code.
• Substantial Equivalence: Identification of predicate devices (Siemens SOMATOM Sensation 64 and Toshiba Aquilion 64) with their FDA clearance numbers and dates.
• Device Description: A general description of the SOMATOM Definition AS/AS+ as a CT X-ray system, its function, software, and output format (DICOM).
• Indications for Use: The intended purpose of the device to produce cross-sectional images of the body.
• General Safety and Effectiveness Concerns: A statement that labeling provides instructions, cautions, and warnings, and that risk management (hazard analysis) is performed to minimize hazards.
• FDA Clearance Letter: Official correspondence from the FDA confirming the substantial equivalence determination.

Therefore, I cannot provide the requested information regarding acceptance criteria or the study that proves the device meets those criteria, as it is not present in the provided text.

If this information were available, it would typically be found in a separate section detailing performance testing, clinical validation, or engineering specifications. For a device like a CT scanner, acceptance criteria would likely relate to image quality parameters (e.g., spatial resolution, contrast resolution, noise, dose efficiency), dose limits, system reliability, and electrical/mechanical safety standards. The study proving these criteria would involve specific tests and measurements.

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