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For radiological image display, archival, retrieval and communications

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The provided text is a 510(k) premarket notification summary for the Medstation device. It primarily focuses on the regulatory approval process and does not contain information about the device's acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot provide the requested information based on the given text. The document confirms the substantial equivalence of the Medstation device to a legally marketed predicate device for radiological image display, archival, retrieval, and communications, but it does not detail the technical performance studies.

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MedStation® PACS is a system designed to acquire, store, display and print medical images from the following diagnostic devices: Computed Tomography (CT), Magnetic Resonance Imagers (MRI), Computed Radiography (CR), Direct Radiography (DR), Ultrasound and X-ray Films.

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This document is a 510(k) premarket notification acceptance letter for a Picture Archiving and Communications Systems (PACS) device, K973090, dated October 28, 1997. It describes the device's indications for use and states that it has been found substantially equivalent to predicate devices. However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document only states:

• Device Name: MedStation® PACS
• Indications for Use: MedStation® PACS is a system designed to acquire, store, display and print medical images from the following diagnostic devices: Computed Tomography (CT), Magnetic Resonance Imagers (MRI), Computed Radiography (CR), Direct Radiography (DR), Ultrasound and X-ray Films.
• Regulatory Class: Unclassified
• Product Code: 90 LMD

Therefore, I cannot provide the requested information in a table or answer the specific questions about studies, sample sizes, ground truth, or expert qualifications, as this data is not present in the provided text. This type of information would typically be found in a separate 510(k) summary or a detailed clinical/technical report, not in the acceptance letter itself.

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