FDA Clears Cervical Spine Fracture Analysis Software

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to a radiological computer aided triage and notification software for the detection of cervical spine fractures.

According to the FDA’s summary document, the device is a “radiological computer aided triage and notification software indicated for use in the analysis of cervical spine CT images.” It is “intended to assist hospital networks and appropriately trained physician specialists by flagging and communication of suspected positive findings compatible with acute cervical spine fractures including non-displaced fracture lines and/or displaced fracture fragments.”

The device utilizes “an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone application in parallel to the ongoing standard of care image interpretation.” It is “not designed to detect vertebral compression fractures.”

The user of the device is “presented with notifications for cases with suspected findings.” Device notifications are meant for informational purposes only and not meant for diagnostic purposes. Furthermore, the device “does not alter the original medical image, and it is not intended to be used as a diagnostic device.”

Additionally, the results from the device are “intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images.” Clinicians who receive the notifications are “ultimately responsible for reviewing full images per the standard of care.”

in order to qualify for shorter and earlier 510(k) clearance a device must be substantially equivalent to a predicate device. Here, the device is substantially equivalent to the BriefCase for CSF Triage manufactured by Aidoc Medical, Ltd. It is substantially equivalent with regard to indications for use, performance, and technological characteristics. The predicate device is a radiological computer aided triage and notification software.

France-based Avicenna.AI submitted the device for 510(k) clearance. Avicenna.AI is a medical imaging company focused on artificial intelligence solutions. The device is called the CINA-CSpine.

Avicenna.AI Co-Founder and CEO Cyril Di Grandi commented, “Cervical spine fractures are serious injuries that require prompt and appropriate medical attention, especially if the spinal cord is involved, so accurate diagnosis is essential.”

Di Grandi continued, “With CINA-CSpine, we aim to help reduce the delay between scan and interpretation, which is critical in the treatment of this condition.”