HipGuide (V 1.0.0.0)

HipGuide is a software application that assists surgeons during hip replacement procedures by providing calibrated measurement overlays, alignment guides, and visual reference markers on fluoroscopic images. It supports intra-operative decision-making through manual placement of points and lines on live or captured fluoroscopic images, and is not intended to replace surgeon judgment or serve as a diagnostic tool.

Both HipGuide and the predicate device (PhantomMSK Hip) make measurements using intra-operative radiographic images from a mobile C-arm in the operating room. The key difference is that the predicate device is mounted on a monitor cart connected to C-arm video output and uses algorithmic automated landmarks, while HipGuide works with flat-panel detector images and relies on manual landmark placement and measurement tool positioning by the user.

Not stated in this summary. The document mentions that bench testing was performed in connection with Software Verification Testing and notes that no FDA-recognized consensus standards were used, and no guidance documents or consensus standards are cited.

HipGuide is substantially equivalent to PhantomMSK Hip because both devices utilize the same principle of operation—making measurements using intra-operative radiographic images acquired by a mobile C-arm during total hip arthroplasty procedures. Measurement accuracy testing demonstrated HipGuide achieves ±5 mm for linear measurements and ±5° for angular measurements, supporting performance consistency with the predicate device for its intended intraoperative use.