OrthoNext Platform System
K242270Orthofix Srl · cleared 2024-12-19 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The subject OrthoNext™ Platform System is a web-based modular software system, indicated for assisting healthcare professionals in planning of orthopedic surgery and treatment both preoperatively and postoperatively, including deformity analysis and correction with several Orthofix products.”
source quote (p.10)
“In addition, considerations on accuracy, specificity and sensitivity of the AI/ML algorithm for the automatic marker detection have been included in the submission:”
Validation studies (1)
Bench
n=1,000 images
endpoints: Accuracy; Specificity; Sensitivity; Precision; FPR; F1 Score
standards: ANSI AAMI IEC 62304:2006 + A1:2016, FDA Guidances "Content of Premarket Submissions for Device Software Functions", General Principles of Software Validation, IEC 62366-1
Reported performance (6 observations)
source quote (p.10)
“AI/ML Algorithm Sensitivity (TPR): 0.75”
source quote (p.10)
“AI/ML Algorithm Specificity (Precision): 1”
source quote (p.10)
“AI/ML Algorithm Accuracy: 0.8”
source quote (p.11)
“F1 Score 0.86”
source quote (p.10)
“Sensitivity: the sensitivity of the subject device is 1 mm for linear measurements and 1 degree for angular measurements.”
source quote (p.10)
“Sensitivity: the sensitivity of the subject device is 1 mm for linear measurements and 1 degree for angular measurements.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).