UNiD Spine Analyzer
MEDICREA INTERNATIONALThe UNiD Spine Analyzer is a web-based software designed to help healthcare professionals view and measure spine-related images, and plan orthopedic surgeries. It assists with measurements, surgical planning including osteotomies, and templating implants, enabling surgeons to prepare and validate plans for patient-specific spine implants.
Intended Use
The UNiD Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons or service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.
Technology
The software is a web-based solution that allows viewing and measuring spine images (jpeg, png, gif formats) to assist in planning orthopedic surgeries including osteotomies and implant templating. It supports generic and spine-specific measurements, and facilitates ordering patient-specific rods. The software runs on a server and requires human intervention for image interpretation and manipulation.
Performance
Verification and validation testing was conducted comparing measurement accuracy (angles and distances) to predicate device Surgimap 2.0. Mean errors for distances were 0.23mm and for angles 0.2°. Surgical tool measurements showed mean error around 0.25° to 0.4°. All testing demonstrated substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/19/2017
4 months - 2
FDA Approval
5/24/2017
Other devices from MEDICREA INTERNATIONAL
- UNiD Spine Analyzer2022 • 510K
- UNiD Spine Analyzer2018 • 510K
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