MyShoulder Planner (5.3SSWPL)

The MyShoulder Planner is a Class II medical device software designed for preoperative planning in total shoulder replacement surgery, utilizing CT scan image processing to facilitate precise anatomical visualization and implant component placement. This digital tool aims to enhance surgical accuracy and patient-specific planning for humeral and glenoid components, having demonstrated safety and effectiveness through rigorous software validation for its substantial equivalence determination.

The MyShoulder Planner (5.3SSWPL) by Medacta International S.A. has received an official determination as a Class II medical device, categorized under shoulder joint metal/polymer semi-constrained cemented prostheses. This decision signifies its substantial equivalence to already legally marketed predicate devices, enabling Medacta International S.A. to proceed with marketing the software, provided it maintains compliance with general regulatory controls such as registration, device listing, and good manufacturing practices. Functioning as a critical preoperative planning tool, the MyShoulder Planner is designed for surgeons performing total shoulder replacement surgery on skeletally mature patients. Its core methodology involves processing CT scan images to facilitate the visualization, measurement, and reconstruction of anatomical data, specifically for planning the placement of humeral and glenoid components from Medacta Shoulder System prostheses. The science behind its utility lies in its ability to assist surgeons in precise implant size and positioning decisions, generate tailored patient-specific planning reports, and streamline requests for patient-matched guides, with its safety and effectiveness validated through thorough software verification and performance data analysis.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the MyShoulder Planner specifically integrate with intraoperative navigation systems to ensure precise execution of the preoperative plan?; What long-term clinical outcomes data supports the use of MyShoulder Planner in improving surgical accuracy, reducing complications, or enhancing patient recovery compared to traditional planning methods?; Are there specific patient anatomical complexities or pathological conditions where the MyShoulder Planner demonstrates superior accuracy or is less effective than other planning tools?; What is the validation process for the anatomical data reconstruction from CT scans, and what are the accepted tolerances for measurement accuracy within the software?; How does the software account for variations in surgeon experience or preference in its planning recommendations, or is it purely data-driven?