MyShoulder Planner (5.3SSWPL)

The MyShoulder Planner is preoperative planning software for total shoulder replacement surgery in skeletally mature patients. It processes CT scan images to allow surgeons to visualize, measure, and reconstruct anatomical data, enabling decisions on implant size and positioning for both humeral and glenoid components using the Medacta Shoulder System prosthesis. The software generates patient-specific planning reports and allows surgeons to request patient-matched surgical guides based on their preoperative plan.

The MyShoulder Planner shares the same design concept, principle of operation, general workflow, operative system compatibility, input image format (DICOM), user interface, segmentation and landmark acquisition methods, and measurements output as the predicate Blueprint Patient Specific Instrumentation. The key difference is that MyShoulder Planner does not allow guide design within the software but instead enables surgeons to order pre-designed patient-matched guides from Medacta, consistent with the MyShoulder Placement Guides (K190738).

Not stated in this summary.

Substantial equivalence is established because the subject device and predicate device share identical design principles, workflows, and technical functionality for segmentation, landmark acquisition, and measurement output. The difference in guide management (ordering vs. designing within software) does not create new safety or effectiveness concerns because patient-matched guides are designed and managed under the predicate K190738, which is an already-cleared reference device. Software verification and validation activities demonstrated that automatic segmentation and landmark acquisition performed equivalently to manual methods, supporting the safety and effectiveness of the core planning functionality.