Search Results

To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the breast and axillary tissue, that can be interpreted by a trained physician.

Model OBC-250-PAN Breast Array Coil

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Model OBC-250-PAN Breast Array Coil". This document is a regulatory approval, not a scientific study report. Therefore, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the device was approved based on its similarity to existing cleared devices, not on a new clinical study demonstrating specific performance metrics.

Therefore, I cannot provide a table of acceptance criteria or details about a study that proves the device meets them from the given text.

To reiterate, the document is a regulatory approval notice and does not contain the information requested.

Ask a specific question about this device