PeekMed web

PeekMed web is a cloud-based software system that assists healthcare professionals in pre-operative surgical planning for orthopedic procedures affecting the musculoskeletal system in adults. It imports patient imaging studies (X-ray, CT, MRI), displays them in 2D or 3D environments, performs measurements, overlays digital prosthetic models, and generates planning reports. The system requires clinical judgment and experience for proper use and validation of outputs.

The subject device is a distributed cloud-based system with the same architecture, workflows, and core features as the predicate (model positioning, dimensioning, rotation, prosthetic overlays, automatic/manual planning). Key additions include: new machine learning model variants for knee segmentation and landmarking in lateral X-ray views, updates to existing ML variants for improved performance, and a new ML model type for 3D bone reconstruction from 2D X-rays in addition to 3D imaging modalities.

Not stated in this summary.

Both devices share identical indications for use, intended user population (adult orthopedic surgery patients), clinical purpose, anatomical regions, software architecture, and workflow. The subject device includes enhanced ML capabilities (lateral knee views, reconstruction capability) that do not alter the overall intended use or raise new safety/effectiveness concerns, as they follow the same development, verification, validation, and deployment processes. All ML models met predefined acceptance criteria (DICE ≥90%, MRE ≤7mm, Accuracy ≥90%) on independent external validation datasets, demonstrating substantial equivalence.