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The ABVS Workplace is intended to display ultrasound images of the breast acquired from B-mode imaging using an automatic or handheld scanning linear transducer. The images may be reviewed and analyzed by the physician. The ABVS Workplace is indicated for use as an adjunct to mammography. The ABVS Workplace is not Intended to be used as a replacement for screening mammography.

This premarket notification covers the Siemens ABVS Workplace, an offline image viewing workstation. The ABVS workplace consists of common IT hardware and preinstalled software to ensure that defined hardware requirements are met. The workplace is based on Windows XP.

The provided text describes the Siemens ABVS Workplace, an offline image viewing workstation for breast ultrasound images, and its substantial equivalence to a predicate device. However, it does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, sample sizes for test or training sets, expert qualifications, or adjudication methods.

The document is a 510(k) summary for regulatory clearance, primarily focusing on establishing substantial equivalence to a legally marketed predicate device rather than detailing specific performance studies against pre-defined acceptance criteria for a novel device.

Therefore, I cannot extract the requested information from the provided text. The output will reflect the lack of this information.

Summary of Unavailable Information:

The provided document, a 510(k) summary for the Siemens ABVS Workplace, details the device's general information, intended use, and technological characteristics, and establishes its substantial equivalence to a predicate device for regulatory clearance. However, it does not contain any information regarding specific acceptance criteria for device performance, the results of a study demonstrating the device meets such criteria, the sample sizes used for testing or training, the provenance of data, expert qualifications, adjudication methods, or whether MRMC or standalone performance studies were conducted.

Therefore, I cannot complete the requested tables and sections with the information about acceptance criteria and performance studies.

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