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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

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DentiqAir is a software application for the visualization of imaging information of the oralmaxillofacial region. The imaging data originates from medical scanners such as CT or CBCT scanners. The dental professionals' planning data may be exported from DentiqAir and used as input data for CAD or Rapid Prototyping Systems.

DentiqAir is a pure software device applied for the visualization of imaging information of the ear-nose-throat (ENT) region and oral-maxillofacial region. The imaging data originates from medical scanners such as CT or Cone Beam - CT (CBCT) scanners. This information can be complemented by the imaging information from optical impression systems. The medical professionals' input information and planning data may be exported from Dentiq Air to be used for CAD or Rapid Prototyping Systems.

The provided text describes the 510(k) premarket notification for the DentiqAir device. While it mentions performance tests, it does not include a detailed table of acceptance criteria and reported device performance for all features, nor does it provide a full breakdown of the test set, expert involvement, or MRMC study results typically found in comprehensive performance studies for AI/ML-driven devices.

However, based on the non-clinical testing section, we can infer some information regarding the performance and acceptance criteria for specific functionalities.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document primarily focuses on accuracy tests for measurements made using the device against phantom data. It does not provide performance metrics for segmentation accuracy (e.g., Dice score, Jaccard index) which might be expected for segmentation features.

Note: The phrasing "Less than True Value and more than Dolphin Imaging average" for Volume is a bit ambiguous regarding exact numerical targets, but it implies a comparative target against a predicate device's expected performance. The document states that the test results support substantial equivalence, implying these criteria were met.

2. Sample Size Used for the Test Set and the Data Provenance:

• Sample Size: The document states that accuracy tests were conducted "from loaded CT datasets using phantom." It does not specify the number of CT datasets or phantoms used for this testing.
• Data Provenance: The data used was from "phantom" studies, meaning simulated or controlled anatomical models, not human patient data. The country of origin is not explicitly stated for the phantom data, but the submitter is from the Republic of Korea. It is retrospective in nature, as it's a pre-market submission based on completed testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• Number of Experts: Not applicable. The ground truth for the phantom accuracy tests was established by the known true values of the phantom itself, not by expert consensus.
• Qualifications of Experts: N/A as expert consensus was not the method for establishing ground truth for the stated performance tests.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Given the ground truth for the measurement accuracy tests was based on the known physical properties of the phantom, no human adjudication was necessary for these specific performance metrics.

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:

• MRMC Study: No. The document explicitly states: "Clinical testing is not a requirement and has not been performed." The performance tests described are strictly non-clinical and focus on software functionality and measurement accuracy. This type of study would be highly relevant for devices intended to assist human readers in diagnosis or treatment planning.

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

• Standalone Performance: For the measurement accuracy tests (Length, Angle, HU, Volume), the described testing does reflect standalone performance as it compares the device's measurements directly to the phantom's true values, without human intervention in the measurement process itself.
• The software also includes "segmentation features," and the document states, "Performance testing has been used to validate the safety and effectiveness of the DentiqAir segmentation features in comparison to the predicate devices." However, no specific quantitative standalone performance metrics (e.g., Dice coefficient, precision, recall) for segmentation are provided in this summary.

7. The Type of Ground Truth Used:

• Ground Truth: For the measurement accuracy tests, the ground truth was based on the known physical properties (true values) of the phantom used for testing.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not provided. The document is a 510(k) summary for a software device. While it mentions "software verification and validation testing activities" including "code review, integration review, and dynamic tests," and "performance tests," it does not discuss the training or development of any AI/ML models within the software or the data used for such purposes. The device's segmentation algorithm is mentioned as "Water Shed (a type of graph-cut algorithm)," which is a traditional image processing algorithm rather than a deep learning model requiring a specific training set with labelled data in the sense of modern AI/ML.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth for Training Set: Not applicable. As the document does not describe the use of an AI/ML model that requires a labelled training set in the contemporary sense, the establishment of ground truth for a training set is not discussed. The Water Shed algorithm does not require labeled training data in the same way a deep learning model would.

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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:

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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Dentiq3D is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.

Dentiq3D is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.

Dentiq3D is a dental image software platform for the 3D visualization and analysis of volume data. Dentig3D is optimized for analyzing volume data from CT scan and enables users to examine volume data through 3D visualization, 2D analysis, and various MPR functions to manipulate CT images. The functions include canal tracing, implant simulation, volume segmentation and airway measurement.

The following are the major functions of Dentiq3D.

• Visualizes CT volume data
• Supports various types of data
• Measures 3D object
• Analyzes and filters volume data
• Publishes various forms of report
• 3D visualization by using GPU
• Loads and saves project files
• Restores (Undo) or repeats (Redo) tasks based on operation history
• Supports a user-friendly interface

The provided text describes a 510(k) submission for the Dentiq3D dental imaging software. However, it does not contain specific acceptance criteria or a study detailing the device's performance against such criteria.

The document states:
"Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the subject device. The device passed all of the tests based on pre-determined Pass/Fail criteria." (Page 5, Section 12. Performance Data)

This indicates that internal testing was performed, but the details of these tests, including acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert involvement, are not provided in this 510(k) summary.

Therefore, I cannot fulfill the request to provide the following information from the given text:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• 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
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on establishing substantial equivalence to predicate devices (Ez3D Plus and InVivo Dental) based on intended use, technical characteristics, and functionalities, rather than presenting detailed performance study results.

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