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Syngo US Workplace is used to view post processed ultrasound images, to store and print images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM compliant PACS system.

The Siemens ultrasound imaging systems are intended for the following applications. General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imagina".

The modified software feature provides for the measurement of anatomical structures and for analysis packages that provide information.

While the provided text describes the "Syngo US Workplace" and its intended use, it does not contain any information regarding specific acceptance criteria, device performance metrics, or any studies conducted to prove the device meets such criteria.

The document is a 510(k) summary from 2009 for the device, focusing on its regulatory classification, predicate devices, and intended use as a post-processing and measurement tool for ultrasound images. It highlights the Arterial Health Package (AHP) software feature for measuring Intima Media Thickness and referencing normative tables, but it does not include data from performance studies.

Therefore, I cannot populate the requested tables and information based on the given input.

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syngo® US Workplace is used to view post processed ultrasound images, to store and print images, and to manipulate and make measurements on images using a personal computer or a compatible DICOM compliant PACS system.

The syngo US Workplace is used to view images, to store and print images, and to make measurements on images using a personal computer. The software is userinstallable. The images are acquired by ultrasound systems using standardized formatting and are transferred from the ultrasound system to the PC hosting the software by CD-ROM and DVD or a network connection.

This 510(k) submission (K060992) for the syngo US Workplace does not contain a study that establishes acceptance criteria or reports on device performance against such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's absolute performance against predefined acceptance criteria through specific studies. The core of this submission is the claim that the "syngo US Workplace is substantially equivalent to the Siemens family of ultrasound imaging systems and the TomTec Image Arena (K040546)."

The description of the device's function involves viewing, storing, printing, and making measurements on ultrasound images. The FDA's acceptance of the 510(k) indicates that they found the device "substantially equivalent" to existing and legally marketed predicate devices, implying it meets similar safety and effectiveness standards as those predicates. However, there is no detailed study within this document that provides specific performance metrics (e.g., accuracy of measurements, speed of image rendering) or defines acceptance criteria for these metrics.

Therefore, I cannot provide the requested table or answer most of the questions because the information is not present in the provided text.

Here's what can be extracted from the document:

• Device Name: syngo® US Workplace
• Purpose of the Device: To view post-processed ultrasound images, store and print images, and manipulate and make measurements on images using a personal computer or a compatible DICOM compliant PACS system.

Missing Information (Not provided in the document):

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
8. The sample size for the training set
9. How the ground truth for the training set was established

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