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BriefCase-Triage for C-Spine Fracture

by Aidoc

Contact Information

www.aidoc.com/contact-support/ or email:info@aidoc.com

Release Stage

FDA Cleared, Commercial (K242837)

Release Date

October 2024

Version

CSF-02-RT

Regulatory Approval

Please find attached the CSF-02-RT 510(k) summary.

Global Availability

US, EU (CE Marked), UK (UKCA Marked), Canada (MDEL), Australia (ARTG), New Zealand, Israel (AMAR), UAE and South Africa.

Summary

The C-Spine Fracture solution is a radiological computer-aided triage and notification software indicated for use in the analysis of CT scans that include the cervical spine, in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating linear lucencies in the cervical spine bone in patterns compatible with fractures (the algorithm does not distinguish between chronic and acute fractures at this time). The C-Spine Fracture solution uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation. When suspected findings are detected, users receive notifications that include compressed preview images. These previews are for informational purposes only and are not intended for diagnostic use beyond the initial notification. The results of the C-Spine Fracture solution are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images. Ultimately, notified clinicians are responsible for viewing full images per the standard of care.

Uses and Directions

Intended Use

The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive findings of C-Spine Fracture pathologies.

Primary Users

The BriefCase-Triage is intended to be used by appropriately trained medical specialists. Appropriately trained medical specialists for CSF are Emergency physicians, radiologists, neuro-surgeons, neurologists, orthopedists.

How to Use

The user is presented with notification for cases with suspected findings. Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The results of the C-Spine Fracture solution are intended to be used in conjunction with other patient information and based on their professional judgment, to assist with triage/prioritization of medical images.

Target Population

patients Adults or transitional adolescents aged 18 and older.

Cautioned Out-of-Scope Settings

Cautioned Out-of-Scope Settings

Only for use in workflow triage, and only for use by appropriately trained medical specialists. Please refer to BriefCase-Triage User Guide (UG0009) for further information on warnings and precautions.

EHR Compatibility

EHR-agnostic

This solution works independently of specific EHR systems and can be integrated with most healthcare IT infrastructures.