MyShoulder Planner (5.3SSWPL)
Medacta International S.A.MyShoulder Planner is a software tool designed for surgeons to plan total shoulder replacement surgeries. It processes CT scans to create 3D models of the patient's shoulder anatomy using machine learning algorithms, helping surgeons decide implant size and positioning before surgery. It also generates patient-specific reports and allows ordering of patient-matched guides to assist in surgery.
Intended Use
The MyShoulder Planner software is a medical device intended for use by surgeons as a preoperative planning tool for total shoulder replacement surgery in skeletally mature individuals. The software supports planning the humeral and glenoid components using Medacta Shoulder System prosthesis and processes CT images to visualize, measure, and reconstruct anatomical data, enabling implant size and positioning decisions. It generates patient-specific planning reports and allows ordering of patient-matched guides according to the presurgical plan.
Technology
The software creates patient-specific preoperative plans based on CT images. It uses machine learning algorithms for automatic segmentation of a 3D model of the patient's shoulder anatomy or manual segmentation by a Medacta engineer. It supports visualization, measurement, annotation of anatomical structures, and generates patient-specific reports. It allows users to request patient-matched surgical guides.
Performance
Verification and validation activities were conducted including software verification and validation of segmentation performance, which showed adequate accuracy compared to manual segmentation. No clinical studies were conducted.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/8/2024
8 months - 2
FDA Approval
1/30/2025
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