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510(k) Data Aggregation
(132 days)
DentiqGuide
DentiqGuide 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 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 necessary medical training in implantology and surgical dentistry.
DentiqGuide is a software device used to pre-operatively plan the placement of a dental implant and to visualize a patient's CT image optionally aligned to an optical 3D surface data. Virtual crowns can be used to guide the planning under the final prosthetic aspect. The surgical guide data can be designed then exported to an external system for manufacturing.
The device has no patient contact.
The followings are the major functions of DentiqGuide.
- Patient management and operation plan management
- Data loading and matching
- Crown model management and mesh editing
- Panoramic screen creation and neural tube setting
- Implant planning
- Surgical guide design
- Report
- Project information management
- Interworking with cloud
Here's a summary of the acceptance criteria and study findings for the DentiqGuide device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Criteria | Performance Criteria (P/F) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|---|
| Accuracy (Measurement) | Length measurement from loaded CT datasets using phantom. | Average and maximum absolute difference less than 2% of true value. | Not explicitly stated but "testing results support..." | Yes (Implied) |
| Accuracy (Measurement) | Angle measurement from loaded CT datasets using phantom. | Average and maximum absolute difference less than 2% of true value. | Not explicitly stated but "testing results support..." | Yes (Implied) |
| Accuracy (Measurement) | Hounsfield Unit (HU) measurement from loaded CT datasets using phantom. | Average and maximum absolute difference less than 2% of true value. | Not explicitly stated but "testing results support..." | Yes (Implied) |
| Accuracy (Surgical Guide) | Generated output surgical guide matches user input requirements (Guide thickness). | Average and maximum absolute difference less than 2% of user input. | Not explicitly stated but "testing results support..." | Yes (Implied) |
| Accuracy (Surgical Guide) | Generated output surgical guide matches user input requirements (Offset from teeth to guide). | Average and maximum absolute difference less than 2% of user input. | Not explicitly stated but "testing results support..." | Yes (Implied) |
| Accuracy (Surgical Guide) | Generated output surgical guide matches user input requirements (Offset from sleeve to guide). | Average and maximum absolute difference less than 2% of user input. | Not explicitly stated but "testing results support..." | Yes (Implied) |
| Accuracy (Implant Library) | Size of implants in library (Diameter) compared to real size values. | Average and maximum absolute difference less than 2% of real size. | Not explicitly stated but "testing results support..." | Yes (Implied) |
| Accuracy (Implant Library) | Size of implants in library (Length) compared to real size values. | Average and maximum absolute difference less than 2% of real size. | Not explicitly stated but "testing results support..." | Yes (Implied) |
| Software Verification | Code review, module review, integration review. | N/A (Verification activities) | Conducted | Yes |
| Software Validation | Dynamic tests. | N/A (Validation activities) | Conducted | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set. It mentions "CT datasets using phantom" for accuracy tests.
The data provenance is a "phantom," which is a controlled, artificial object used for testing, rather than patient-specific data from a country of origin. The study appears to be retrospective in terms of analyzing the phantom data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish ground truth for the phantom-based test set. The ground truth for the phantom was based on its "true values" as a known controlled object.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method for the test set, as the ground truth was established by the known physical properties of the phantom.
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:
No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The DentiqGuide software is for "pre-operative planning and simulation" and is a tool to support practitioners, not an AI for diagnosis or assisting human readers in detection tasks in the traditional sense of an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the performance tests described (accuracy tests for measurement, surgical guide generation, and implant library) evaluated the algorithm's performance in a standalone manner, specifically its ability to accurately measure and generate outputs based on input data and defined parameters. The statement "results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed radiologists, clinicians and referring physicians as an adjunctive to standard radiology practices for diagnosis" indicates that while the software has standalone capabilities, human interpretation remains crucial.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
For the performance tests, the ground truth used was the "true values" of a physical phantom. This implies known, precisely measured dimensions and characteristics of the phantom itself.
8. The Sample Size for the Training Set:
The document does not provide any information regarding a training set sample size. This suggests that the device likely relies on deterministic algorithms or established image processing techniques rather than a machine learning model that requires a large training dataset.
9. How the Ground Truth for the Training Set Was Established:
Since no training set is mentioned, no information is provided on how ground truth for a training set was established.
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