PeekMed web

PeekMed web is a cloud-based software system that helps healthcare professionals perform pre-operative surgical planning for orthopedic procedures (hip, knee, upper limb, foot) in adults. It processes imported medical imaging studies, displays them in 2D or 3D, allows positioning of digital prosthetic templates, and generates planning reports with measurements and annotations.

Both subject and predicate devices are cloud-based, multi-platform medical image processing systems with identical workflows: import images, configure, identify case, perform pre-surgical planning, and export results. The subject device includes new/improved machine learning models for segmentation and landmarking that now support X-ray imaging for foot procedures (predicate supported only CT for foot), but development, validation, and deployment processes are identical.

Not stated in this summary.

Substantial equivalence is based on identical intended use, indications for use, end-user population (adult patients, healthcare professionals), anatomical regions, and overall technical functionality. Both devices perform the same pre-operative planning workflow with internet connectivity, digital template overlap, interactive model positioning, and automatic/manual planning modes. The new ML model variants were developed, trained, tested, and externally validated using identical procedures with separate validation datasets meeting predefined acceptance criteria (DICE ≥90% for segmentation, MRE ≤7mm for landmarking, Accuracy ≥90% for classification). The addition of X-ray support for foot planning does not change intended purpose or raise safety/performance questions because the ML development and validation processes are the same.