Search Results

Bridge-RT is a Medical Device intended to be used for reviewing and assessment of DICOM based datasets which may occur in a radiotherapy environment. It is used by qualified specialist to load and display data generated by different DICOM devices including: RT-STRUCT, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR and PET.

The software provides the radiotherapy specialist with the necessary visualization and image manipulation tools to review, present or compare DICOM-RT related datasets including the geometrical super imposition of 3D plan data.

Bridge-RT is intended for reviewing purposes only and is not capable to generate new or modified RT plan data.

Not Found

The provided text is a 510(k) premarket notification FDA letter for the Bridge-RT 2.0 device. This type of document does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a clinical trial report or a more comprehensive technical submission.

The letter explicitly states that the device is for "reviewing and assessment of DICOM based datasets" and "is intended for reviewing purposes only and is not capable to generate new or modified RT plan data." This indicates that the device is primarily a visualization and image manipulation tool, not an AI diagnostic or treatment planning system that would require performance metrics like sensitivity, specificity, or reader improvement studies.

Therefore, I cannot provide the requested information from the given text. The text does not describe an acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI or diagnostic accuracy.

Ask a specific question about this device