Search Results

The "MICS INTERVENTION AID (MICS-MIA and MICS-MIAS)" is for use in conjunction with a Magnetic Resonance Scanner and the Machnet Bilateral Open Breast Coil to localize lesions in female breasts and perform needle biopsies accurately. For use by a trained physician.

The MR-Mammography Intervention Aid basically consists of a transparent acrylic plate containing about 600 puncture holes of 4 mm in diameter, held in a frame containing a set of MR fiduciary markers. The device can easily and firmly be attached to the Bilateral Open Breast Coil, thereby positioning and compressing the breast against a Breast Support Pad. The device comes with a (blue) Sliding Locator Plate for easy eyeretrieval of the software-established puncture hole, a detachable Fiduciary Marker Plate and sterilizable Needle Guide. The Mammography Intervention Aid comes with a PC-software package for supporting the calculation of the location and depth of puncturing. Information regarding the coordinates of a lesion and of the MR fiduciary markers should be retrieved from a relevant MR image and are input to the MICS software package. The software may calculate which hole to puncture through and how deep. A notebook PC with MIA Software Package installed is a system option

The provided document is a 510(k) summary for a medical device (MICS INTERVENTION AID) and does not contain the details of a study that directly proves the device meets specific acceptance criteria in the format requested.

The document states that the device is "substantially equivalent" to predicate devices and that "Testing was performed according to internal company procedures. Test results support the conclusion that actual device performance satisfies the design intent." However, it does not provide:

• A table of acceptance criteria with reported device performance against those criteria.
• Details about sample size, data provenance, number/qualifications of experts, adjudication methods, or specific study types (MRMC, standalone).
• Information about training set size or how ground truth for the training set was established.

This 510(k) submission relies on demonstrating substantial equivalence to already legally marketed devices, rather than presenting a novel study with detailed acceptance criteria and performance metrics against those criteria.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as that information is not present.

Ask a specific question about this device