UNiD Spine Analyzer
MEDICREA International, Inc.The UNiD Spine Analyzer is a web-based software tool that helps surgeons and healthcare providers view and measure spine-related medical images, plan surgical procedures, and simulate surgical strategies. It incorporates machine learning predictive models to assist in preoperative planning and includes a database of implant templates to aid in selecting and placing surgical implants. The software enhances clinical decision-making by providing quantitative radiographic parameters and predictive outputs for spine surgery planning.
Intended Use
The UNiD Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. It allows surgeons and service providers to perform generic and spine-related measurements and to plan surgical procedures, including measuring anatomical components for placement of surgical implants.
Technology
The device is a web-based Software as a Medical Device (SaMD) that performs preoperative and postoperative image measurements and simulates surgical planning steps for spine surgery. It uses static machine learning-based predictive models trained with retrospective longitudinal patient data to generate predicted values of radiographic parameters. The software includes generic and specialty measurement tools, surgical simulation tools, and a preselected implant template database.
Performance
No new human clinical testing was required; safety and effectiveness are supported by equivalence to predicate devices and non-clinical testing. The software passed verification and validation per FDA guidelines and risk management standards. Usability studies demonstrated comprehension, appropriate human factors, and ease of use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/28/2021
6 months - 2
FDA Approval
1/12/2022
Other devices from MEDICREA International, Inc.
- UNiD Spine Analyzer2018 • 510K
- UNiD Spine Analyzer2017 • 510K
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