(87 days)
VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.
VARO Plan is a pure software device.
VARO Plan is a dental implant surgical guide design software that is used to design surgical procedure guidelines for implanting one or more dental implants based on CT and the Tray data. Implant library, which includes certified implants, and sleeve libraries are provided. The guide model designed in accordance with the established dental implant operation plan can be exported as STL files.
The followings are the major functions of VARO Plan.
- Patient Management and Surgical Plan Management
- Data Management and Matching
- Crown Model Management and Mesh Edit
- Panoramic Screen Generation and Nerve Setting
- Implant Simulation
- Surgical Guide Design
- Results output.
- Report
- Project Information Management
Here is a summary of the acceptance criteria and study information for the VARO Plan device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Accuracy of Measurements on CT Datasets (using phantom) | Average Absolute Difference |
§ 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).