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CADimas™ V1.0 is indicated for processing of dynamic contrast enhanced MR images. CADimas™ V1.0 provides enhanced visualization for image interpretation.

CADimas V1.0™ is a post-processing software package intended for use in viewing and analyzing magnetic resonance imaging (MRI) studies. CADimas™ supports evaluation of dynamic MRI data acquired during contrast administration. CADimas™ segments and labels tissue types based on kinetic and margin characteristics of enhancement patterns (parametric image maps), and performs other user-defined post-processing functions (image subtractions. multiplanar reformats).

This document addresses the regulatory clearance of CADimas™ V1.0, a post-processing software for dynamic contrast-enhanced MRI studies. However, it does not contain information regarding acceptance criteria, device performance studies, or other specific details requested in your prompt (e.g., sample size, ground truth, expert qualifications, MRMC studies).

The provided text is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices and subsequently, a letter from the FDA confirming clearance.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the information provided. The document explicitly states:

• "We have reviewed the above referenced premarket notification submission for CADimas™ W 1.0, which contains MR contrast agent as a drug component. This drug component is labeled . I . , whiles contains this contrast enhanced MR images of female breasts. We have discussed the use of this drug component for the indicated use with our Center for Drug Evaluation and Research (CDER) and have been advised that such use constitutes either a new or modified indicated use which has not been found to be safe and/or effective by CDER. Because of this determination, we are unable to complete our review of your section 510(k) notification." This indicates an initial rejection due to the drug component, not an evaluation of the device's performance against specific criteria.
• The subsequent approval letter simply states "we have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined that this device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This is a determination of substantial equivalence, not an assessment of performance against quantifiable acceptance criteria through clinical studies described in the prompt.

No information is present in the provided text to fulfill your requests regarding acceptance criteria, study design, or performance metrics.

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