CustomSurg OrthoPlanner

CustomSurg OrthoPlanner is a web-based medical software system that assists orthopedic surgeons with pre-operative surgical planning. It imports diagnostic imaging studies (x-rays and CT scans) and integrates a database of digital representations of implant materials, allowing surgeons to create 3D visualizations and digitally perform surgical planning. The software requires surgeon clinical judgment and experience and is not intended to replace device instructions or perform intraoperative functions.

Both CustomSurg OrthoPlanner and the predicate device (PeekMed) are medical software enabling orthopedic pre-surgical planning in a healthcare setting. Both require clinical judgment and experience, share similar workflows, planning features (model representation, digital representation of prosthetic material), and use requirements (internet connection, output validation). Neither device uses artificial intelligence. The key difference is CustomSurg OrthoPlanner lacks direct PACS integration and does not support MRI image import, whereas PeekMed does.

ISO 14971 was completed as part of the software design and development effort. CustomSurg's design control processes were used for verification and validation testing.

The differences in PACS interface capability and MRI support are characterized as clinically irrelevant features regarding image import methodology only, not the core intended purpose of serving as a pre-surgical planning support tool. Since both devices share the same intended use, intended user, similar intended population, and similar technological workflows and planning features, and the identified differences do not raise new safety or effectiveness questions, substantial equivalence is established.