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MedDream is a software only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DI COM or HL 7 data, including mammographic images, and bio signals. MedDream also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive. It supports the physician in diagnosis. For primary image diagnosis in Mammography only uncompressed images must be used. Typical users of this system are trained professionals, including but not limited to physicians, radioal technicians, and assistants. Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes. For users in the United States of America: Mobile device display is not intended for diagnostic purposes.

MedDream is a software only Medical Image Management and Processing System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DI COM or HL 7 data, including mammographic images, and bio signals. MedDream also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive.

I am unable to provide the detailed information requested regarding the acceptance criteria and study that proves the device meets them. The provided text is an FDA 510(k) clearance letter for the MedDream device and an "Indications for Use" statement.

This document does not contain the detailed study design, acceptance criteria, or performance data for the device. FDA 510(k) clearance letters primarily state that the device has been found substantially equivalent to a predicate device and outline the regulatory requirements for marketing. They do not typically include the technical specifics of the validation studies.

To answer your request, I would need access to the actual 510(k) summary or the full submission, which would detail the performance testing and acceptance criteria. This information is usually found in the device's 510(k) Premarket Notification submission, which may or may not be publicly available in full. The provided text is just the FDA's decision letter.

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MedDream is a software medical imaging system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. Software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians, clinicians.

Contraindications: The MedDream is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel only who are qualified to create and diagnose medical image data.

MedDream is a software medical imaging system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces.

The provided document is an FDA 510(k) clearance letter for a device named "MedDream". This document is a regulatory approval, not a technical study report that would detail acceptance criteria and a study proving those criteria were met for an AI/CAD/imaging analysis device.

The "MedDream" device is described as "a software medical imaging system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces." It is further stated that the "Software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians, clinicians."

Based on this description, MedDream appears to be a Picture Archiving and Communications System (PACS) or a similar medical image viewing and management software, not an AI or CAD device that performs image analysis and provides diagnostic interpretations requiring specific performance metrics like sensitivity, specificity, or AUC.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for an AI-powered diagnostic or analysis tool. The clearance is based on substantial equivalence to a predicate device for its PACS functionalities, not on the performance of a specific AI algorithm.

Consequently, I cannot fill in the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI component, as this information is not present in the provided FDA clearance letter.

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