(49 days)
The OrthoVis Preoperative Plan is a preoperative plan document created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement. The OrthoVis Software and resulting Preoperative Plan is indicated for use with the DePuy Global APTM Shoulder glenoid, Global Shoulder StepTech™ Anchor Peg glenoid, or Delta XtendTM Reverse Shoulder metaglene components.
The indications for use of the DePuy shoulder systems with which the OrthoVis Preoperative Plan is intended to be used are the same as those described in 510(k) KI23122.
The OrthoVis Preoperative Plan is a preoperative plan document that is created in OrthoVis software. A patient CT scan is loaded into OrthoVis software and the desired bony anatomy can be separated and segmented with OrthoVis tools, allowing extracted and segmented bones (e.g., scapula, humerus) to be virtually implanted with shoulder replacement implants. OrthoVis currently is used only with the DePuy Global APG glenoid, DePuy Global StepTech, and DePuy Delta Xtend components for total shoulder arthroplasty. OrthoVis can then produce a preoperative plan document (.pdf file), the OrthoVis Preoperative Plan, that contains text, images, and in electronic format, a rotatable 3D model(s) of the implanted component and bone. This preoperative plan document is labeled, via a watermark, as unapproved until the ordering surgeon approves the plan, at which point such labeling is removed and the final plan provided to the ordering surgeon.
The following information describes the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal acceptance criteria with numerical targets. However, the non-clinical testing performed aims to demonstrate the device's ability to accurately perform its intended use and function, particularly in aiding accurate guide pin placement in total shoulder arthroplasty.
| Feature Tested/Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software Accuracy (Dimensional Validation) | Accurate measurement and portrayal of known lengths in CT scanned objects. | Showed that known lengths of actual CT scanned objects could be accurately measured and portrayed within the OrthoVis software. |
| Accuracy of Guide Pin Placement (Version) | Improvement in accuracy compared to standard of care. | Improved accuracy by 4.5° (±1° s.d.) compared to standard of care instruments (p |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).