BriefCase-Triage for Vertebral Compression Fracture

by Aidoc

Contact Information

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

Release Stage

FDA Cleared, Commercial (K222329)

Release Date

September 2022

Version

VCFx-01

Regulatory Approval

Please find attached the VCFx-01 510(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 Vertebral Compression Fracture solution is a radiological computer aided triage and notification software indicated for use in the analysis of chest and abdominal CT images. The device is intended to assist hospital networks and appropriately trained medical specialists within the standard-of-care bone health setting in workflow triage by flagging and communication of suspected positive cases of Vertebral Compression Fractures (VCFx) findings. The Vertebral Compression Fracture solution uses 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. The device does not alter the original medical image and is not intended to be used as a diagnosis device. The results of the Vertebral Compression 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. 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 cases of vertebral compression fracture (VCFx) pathology.

Primary Users

The Vertebral Compression Fracture solution is intended to be used by appropriately trained medical specialists. Appropriately trained medical specialists for Vertebral Compression Fractures are radiologists, neurosurgeons, general surgeons, orthopedic surgeons, MSK specialists, and interventional radiologists, within the bone health settings.

How to Use

Hovering over a line in the feed pops up a compressed, low-quality, grayscale, unannotated image that is captioned "not for diagnostic use", "for prioritization only" and is displayed as a preview function. This compressed preview is meant for informational purposes only, does not contain any marking of the findings, and is not intended for primary diagnosis beyond notification.

Target Population

patients Adults or transitional adolescents aged 18 and older.

Cautioned Out-of-Scope Settings

Notifications include compressed preview images that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device. 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.