(119 days)
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.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.