Search Results

The Vimplant is intended for use as a software interface for the transfer of imaging information from a CT scanner and also as a pre-operative software for simulation and evaluation dental implant placement and surgical treatment options.

VImplant™ is a dental implant simulation software for dentists and implantologists. By use of VImplant™, dental practicians can plan and practice their surgery in advance so they can reduce some risks which can happen during their real surgery. Vimplant™ provides very useful and needful functions. It contains functions of implant simulation, manipulation with 2D and 3D mode, nerve identification, and evaluation of bone density. By using Vimplant TM, dental practicians can quickly and easily simulate implant surgery on their desktop PCs. This enables them to conduct implant surgery more effectively by isolating the exact implant position site and angle and to assist in deciding the proper implant diameter, length, etc.

The provided text is a 510(k) summary for the Vimplant™ Dental implant simulation software. It focuses on demonstrating substantial equivalence to predicate devices and describes the software's functionalities and intended use. However, it does not contain the specific information required to answer your questions regarding acceptance criteria, a dedicated study proving device performance against those criteria, or details about ground truth establishment for a test set or training set.

Here's an analysis of what is available and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance:

• Missing: The document does not provide a table of acceptance criteria or reported device performance metrics against specific criteria. The submission methodology is one of "substantial equivalence" to existing predicate devices, not performance against pre-defined quantitative acceptance criteria.

2. Sample size used for the test set and the data provenance:

• Missing: There is no mention of a dedicated test set, its sample size, or the provenance of any data used for testing. The basis of equivalence is functional similarity and technical characteristics to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Missing: As there's no mention of a test set where ground truth was established, this information is not present.

4. Adjudication method for the test set:

• Missing: No specific adjudication method is mentioned as there's no described test set requiring one.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Missing: This 510(k) summary does not describe an MRMC study. The device is software for planning and simulation, not an AI diagnostic aid that would typically undergo such a study to evaluate reader performance improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Missing: While the device is a standalone software, the document does not describe "standalone performance" in the context of a rigorous, quantitative study with metrics like sensitivity, specificity, etc. It focuses on the capabilities and functions of the software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Missing: No ground truth is mentioned as there's no performance study described. The "reliability and validity" of the 3D image construction method were "already verified in Vworks™" (a predicate device by the same manufacturer), suggesting reliance on prior work rather than a new ground truth establishment process for Vimplant.

8. The sample size for the training set:

• Missing: This document focuses on the software's features and its substantial equivalence to predicate devices. It does not contain information about a training set, which would typically be relevant for machine learning or AI algorithms that undergo a training phase.

9. How the ground truth for the training set was established:

• Missing: As there's no training set mentioned, this information is not provided.

Summary of available information:

• Device Name: Vimplant™ Dental implant simulation software
• Intended Use: As a software interface for transferring imaging information from a CT scanner, and as pre-operative software for simulation and evaluation of dental implant placement and surgical treatment options.
• Key Functions: Import DICOM 3.0 data, 2D image reformation (panoramic, cross-sectional), 3D image construction (Surface rendering, verifiable through Vworks™), nerve creation and display, implant simulation (placement, manipulation, property changes), collision detection, sinus bone graft volume estimation, measurement functions (bone density, length, angle, 3D distance), report and image library.
• Predicate Devices: SimPlant System (MATERIALISE N.V., K033849) and V-works™ (CyberMed, Inc., K013878).
• Basis for Clearance: Substantial equivalence to the predicate devices, implying similar safety and effectiveness based on similar technological characteristics and intended use. The 3D image construction's reliability and validity were already verified in the predicate V-works™ system.

The 510(k) summary provided here is characteristic of a submission for a software device that relies on functional equivalence to established technology rather than a novel AI algorithm requiring extensive performance studies with ground truth data.

Ask a specific question about this device