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The Telemis-Medical solution is a software package intended for the acquisition, management, distribution and display of medical images within the healthcare system.

The Telemis-Medical Solution is a Medical Image Management software package designed to perform required functions for the import, storage, archive, distribution, review, analysis of digital medical images in DICOM 3.0 and other formats. The Telemis Medical Solution consists of the TM-AutoAcquisition. TM-Worklist. TM-Server. TM-Reception, TM-ReceptionHE, TM-Reception Lite, TM-Home, TM-Link and TM-Publisher.

TM-AutoAcquisition acquires image studies from medical devices, converts them into secure multimedia documents and sends them to the TM-Server. The TM-Worklist is used by the TM-AutoAcquisition to validate patient information. The TM-Server manages documents and security permissions. The TM-Reception allows authenticated users to retrieve, manage, review and process their image documents. The TM-ReceptionHE is an enhanced TM-Reception that provides users with extra image processing features. The TM-Reception Lite allows users to manage and review local image documents. The TM-Home delivers TM-Reception's features for personal use. The TM-Link provides transparent integration between Telemis-Medical and Electronic Patient Record system. The TM-Publisher makes image study summary available on CD-ROM, paper or e-mail.

The provided text is a 510(k) summary for the Telemis-Medical PACS system and the FDA's acceptance letter. It describes the device's function, intended use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding specific acceptance criteria, study methodologies, or performance data related to the device's accuracy, efficacy, or safety in a quantitative manner.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method.
• MRMC comparative effectiveness study results or effect size.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on establishing "substantial equivalence" based on technological characteristics and intended use compared to a predicate device (Stentor, Inc. iSite Radiology). It states that "Any differences between the Telemis-Medical solution and the equivalent devices have no significant influence on safety or effectiveness," and concludes that the "Level of Concern" is "minor" because "no software component...whose failure or latent design flaw would be expected to result in death or injury to a patient." This is a qualitative assessment of risk rather than a quantitative performance study.

In summary, the provided text does not contain the detailed study information you requested.

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