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The MEDIPORT is a medical grade device to be used as a platform for PACS software or DICOM viewer software. It is intended for use in all Hospital environments (OR, ER etc.) as well as Physicians' Offices and Clinical Laboratories.

In light of the fact that MEDIPORT is a high performance computer it may also be used to access patient records or perform other functions that may be required.

This device in not qualified or intended for use for mammographic purposes.

The MEDIPORT is a high performance medical grade computer with DICOM calibrated monitors that may be used as a platform for PACS software. It is designed for use in all Hospital environments (OR, ER etc.) as well as Physicians' Offices and Clinical Laboratories. It may also be used to access patient records or perform other functions that may be required.

The Kobo200 document is a 510(k) summary for a medical device called MEDIPORT, a medical-grade computer system intended as a platform for PACS software. The application was filed in 2006. This document does not contain any information about a study that assesses the device's performance against acceptance criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices by comparing technical specifications and safety certifications. The MEDIPORT is presented as a hardware system acting as a host for PACS software, implying its performance is largely tied to the software it runs and its adherence to relevant standards rather than a specific clinical performance metric.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as this information is not present in the provided text. The document is primarily a regulatory filing to establish equivalence for marketing purposes.

Here's a breakdown of why the requested information cannot be extracted:

• Acceptance Criteria and Reported Device Performance: This document states the device's technical specifications (CPU, RAM, Hard drive, etc.) and its adherence to standards like DICOM and UL60601-1. It does not specify acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity for image interpretation) nor the results of a study demonstrating such performance.
• Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for training set: All these points relate to a clinical or performance study, which is entirely absent from this 510(k) summary. The document focuses on hardware specifications and regulatory compliance, not on the performance of a clinical algorithm or diagnostic aid.

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