Search Results
Found 1 results
510(k) Data Aggregation
(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 < 2% | Met |
| Length (phantom) | Maximum Absolute Difference < 2% | Met |
| Angle (phantom) | Maximum Absolute Difference < 2% | Met |
| HU (Hounsfield Units) (phantom) | Maximum Absolute Difference < 2% | Met |
| Surgical Guide Model (phantom) | Generated output surgical guide matches user input requirements (Guide thickness, Offset from teeth to guide, Offset from sleeve to guide) | Met |
| Accuracy of Implant Library Sizes | Average Absolute Difference < 2% | Met |
| Diameter (implant library) | Maximum Absolute Difference < 2% | Met |
| Length (implant library) | Maximum Absolute Difference < 2% | Met |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only mentions accuracy testing using a phantom. It does not specify a sample size in terms of the number of patient cases or images, as the tests were conducted with a physical phantom.
- Sample Size for Test Set: Not specified in terms of distinct "cases" or "patients." The testing used a phantom.
- Data Provenance: Not applicable for phantom testing in terms of country of origin or retrospective/prospective. The data was generated from a phantom.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The ground truth for the phantom-based accuracy testing would be the known true values of the phantom itself. Therefore, no human experts were used to establish this ground truth:
- Number of Experts: 0 (Ground truth established by known physical phantom properties).
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth was based on the known physical properties of the phantom, not on expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect Size: Not applicable, as no MRMC study was performed. The device is a planning and design software, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies described are standalone performance tests of the software's accuracy in measurements and guide generation against known phantom values. The device itself is described as a "standalone Windows-based software application."
7. Type of Ground Truth Used
Phantom-based true values: The ground truth for the accuracy tests was derived from the known physical dimensions, angles, and Hounsfield Units (HU) of a phantom, as well as the predefined design requirements for the surgical guide model.
8. Sample Size for the Training Set
The document does not provide information about a training set size. The VARO Plan is described as "pure software device" for dental implant planning and surgical guide design. This type of software, especially for its primary functions listed (MPR, panoramic generation, implant simulation, surgical guide design based on user input), might not involve a machine learning model that requires a distinct "training set" in the conventional sense. The verification and validation activities mentioned are typical for software engineering rather than AI/ML model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set or machine learning model requiring such a ground truth establishment process is described in the provided information.
Ask a specific question about this device
Page 1 of 1