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BoneMRI is an image processing software that can be used for image enhancement in MRI images. It can be used to visualize the bone structures in MRI images with enhanced contrast with surrounding soft tissue. It is to be used in the pelvic region, which includes the bony anatomy of the sacrum, hip bones and femoral heads; and the lumbar spine region, which includes the bony anatomy of the vertebrae from L3 to S1. BoneMRI is not to be used for diagnosis or monitoring of (primary or metastatic) tumors.

Warning: BoneMRI images are not intended to replace CT images.

The BoneMRI application is a standalone image processing software application that analyses 3D gradient echo MRI scans acquired with a dedicated MRI scan protocol. From the analysis, 3D tomographic radiodensity contrast images, called BoneMRI images, are constructed.

The BoneMRI images can be used to visualize the bone structures in MR images with enhanced contrast with respect to the surrounding soft tissue. The application is designed to be used by imaging experts, such as radiologists or orthopedic surgeons, typically in a physician's office.

The BoneMRI application is a server application running on the clinic or hospital networks. It is available as fully on-premise software with specific GPU hardware requirements, or partly running as a managed service, for which the environment in which the managed modules run is controlled by MRIquidance, but the managed service will not receive protected health information (PHI). Within the hospital network, the application communicates with a DICOM compatible imaging archive (e.g., a PACS) to receive input MRI and to return BoneMRI images. Reading of the resulting BoneMRI images is performed using reqular DICOM compatible medical imaging viewing software.

The application uses an algorithm to detect bone images from MRIs obtained using a specific acquisition sequence. The algorithm training sets included information from multiple clinical sites, multiple anatomies, and multiple scanners to ensure that the trained algorithm was robust with respect to the approved indications for use. None of the data used in the training dataset was used subsequently in the validation dataset.

The document describes the performance testing of BoneMRI v1.6, an image processing software designed to enhance bone structures in MRI images of the pelvic and lumbar spine regions. The study aims to demonstrate that BoneMRI v1.6 meets specified accuracy acceptance criteria for bone morphology, radiodensity, and radiodensity contrast.

Here's the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria were established for the accuracy of 3D bone morphology, radiodensity, and radiodensity contrast when compared to co-registered CT scans.

The results from the validation testing were found to fall within the pre-specified acceptance criteria (p

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