Search Results

Ez3D-i 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.

Ez3D-i 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.

Ez3D-i v5.5 is 3D viewing software for dental CT images in DICOM format with a host of useful functions including MPR, 2-dimensional analysis and 3-dimensional image reformation. It provides advanced simulation functions such as Implant Simulation, Drawing Canal, and Implant Environ Bone Density, etc. for the benefit of effective doctor and patient communication and precise treatment planning.

Here's an analysis based on the provided FDA 510(k) summary for the Ez3D-i /E3 device, specifically version 5.5:

This document is a 510(k) summary for the Ez3D-i /E3 (v5.5) device, asserting its substantial equivalence to a previously cleared device (Ez3D-i /E3 v5.4, K222069). It does not present a standalone clinical study to prove the device meets specific acceptance criteria based on diagnostic accuracy or clinical outcomes. Instead, it relies on demonstrating that the new version is substantially equivalent to a previously cleared version and that software verification and validation tests were performed.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of specific quantitative acceptance criteria related to diagnostic performance or clinical effectiveness, nor does it report such performance metrics. The approval is based on substantial equivalence and software verification/validation.

Instead, the summary implies the "acceptance criteria" are related to successful software verification and validation, ensuring the new features function as intended and the overall device maintains the same functionality and safety profile as its predicate.

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

• Test Set Sample Size: Not explicitly stated for any clinical performance or diagnostic accuracy test. The document refers to "SW verification/validation and the measurement accuracy test," implying internal testing rather than a clinical study with a patient dataset.
• Data Provenance: Not specified, as no clinical study with patient data is detailed. The tests mentioned are likely internal software tests.

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

Not applicable / Not specified. Since no clinical study or diagnostic performance assessment is detailed, there's no mention of experts establishing a ground truth for a test set. The device is a viewing and analysis tool, and its outputs are for interpretation by trained medical professionals.

4. Adjudication Method for the Test Set

Not applicable / Not specified. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not reported in this 510(k) summary. The submission focuses on substantial equivalence based on technical characteristics and software changes, not on comparing human reader performance with and without the AI (or specific features) of the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. The device, Ez3D-i /E3, is described as "dental imaging software that is intended to provide diagnostic tools" and "meant to be used by trained medical professionals such as radiologist and dentist." It is explicitly stated that "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." This confirms it is not intended for standalone, algorithm-only performance.

7. The Type of Ground Truth Used

Not applicable / Not specified for any diagnostic performance. The ground truth for the software's functionality would be its design specifications, against which its operational performance was verified.

8. The Sample Size for the Training Set

Not applicable / Not specified. This device is described as "dental imaging software" with "diagnostic tools" and "advanced simulation functions" primarily for viewing, analysis, and processing. There is no mention of machine learning or AI that would require a "training set" in the context of deep learning algorithms. It appears to be a rule-based or conventional image processing software.

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

Not applicable / Not specified, as there is no mention of a training set for machine learning.

Ask a specific question about this device

Ez3D-i 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.

Ez3D-i 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.

Ez3D-i is 3D viewing software for prompt and accurate diagnosis dental CT images in DICOM format with a host of useful functions including MPR, 2-dimensional analysis and 3-dimensional image reformation. It provides advanced simulation functions such as Implant Simulation, Drawing Canal, and Implant Environ Bone Density, etc for the benefit of effective doctor and patient communication and precise treatment planning. Ez3D-i is a useful tool for an easier diagnosis and analysis by processing a 3D image with simple and convenient user interface.

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study report.

Specifically, the document states: "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." However, it does not elaborate on:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improvement with/without AI assistance.
6. If a standalone performance (algorithm only) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on software validation and mentions adherence to various standards (ISO 14971, ISO 13485, IEEE Std 1012, IEEE Std 829, IEC 62304) and FDA guidance for software, but it does not provide the specific performance data or study design details that would allow me to populate the requested table and answer the study-specific questions.

Ask a specific question about this device

Ez3D-i 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.

Ez3D-i 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.

Ez3D-i is 3D viewing software for prompt and accurate diagnosis dental CT images in DICOM format with a host of useful functions including MPR, 2-dimensional analysis and 3dimensional image reformation. It provides advanced simulation functions such as Implant Simulation, Drawing Canal, and Implant Environ Bone Density, etc for the benefit of effective doctor and patient communication and precise treatment planning. Ez3D-i is a useful tool for an easier diagnosis and analysis by processing a 3D image with simple and convenient user interface. Ez3D-i's main functions are;

• · Image adaptation through various rendering methods such as Teeth/Bone/Soft tissue/MIP
• · Versatile 3D image viewing via MPR Rotating, Curve mode
• · "Sculpt" for deleting unnecessary parts to view only the region of interest.
• · Implant Simulation for efficient treatment planning and effective patient consultation
• · Canal Draw to trace alveolar canal and its geometrical orientation relative to teeth.
• · "Bone Density" test to measure bone density around the site of an implant(s)
• · Various utilities such as Measurement, Annotation, Gallery, and Report
• · 3D Volume function to transform the image into 3D Panorama and the Tab has been optimized for Implant Simulation.
• . Provides the Axial View of TMJ, the Condyle/Fossa images in 3D and the Section images, and supports functions to separate the Condyle/Fossa and display the bone density
• STO/VTO Simulation to predict orthodontic treatment/ surgery results with 3D Photo image.
• · Segmentation function to get tooth segmentation data from CT, label each segmented tooth data as an object and utilize them in simulation such as tooth extraction, implant simulation, etc.

The provided text is a 510(k) summary for the Ez3D-i / E3 dental imaging software. While it states that performance data exists and the device passed tests based on pre-determined criteria, it does not provide any specific quantitative acceptance criteria or the detailed results of a study to demonstrate that the device meets those criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Effect size of MRMC study (as no such study is described).
3. Description of a standalone performance study.

However, I can extract the following information:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified.
• Data Provenance: Not specified. The document only mentions that the software loads, views, and saves DICOM images from various dental imaging equipment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not specified. The document only states that the device is "meant to be used by trained medical professionals such as radiologist and dentist."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified.

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

• Not specified. The document mentions that the software provides "diagnostic tools" and "advanced simulation functions" and that "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." This implies reliance on expert interpretation, but the specific type of ground truth used for testing is not detailed.

8. The sample size for the training set

• Not specified.

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

• Not specified.

Additional Information from the Document:

• Device Type: Dental Imaging Software (Ez3D-i / E3)
• Intended Use: "to provide diagnostic tools for maxillofacial radiographic imaging... 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." Also intended "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."
• Predicate Device: Ez3D-i / E3 (K163539) by EWOO SOFT Co., Ltd.
• Safety and Effectiveness Claim: The submission claims substantial equivalence to the predicate device because "The new device and the predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not introduce a fundamentally new scientific technology, and the nonclinical tests demonstrate that the device is safe and effective."
• New Features in Subject Device: "additional features such as tooth segmentation function and orthodontic simulation function using 3D Photo and segmented data from CT including bone model and tooth model data. Its file import menu and MPR tab also have been upgraded."
• Justification for Equivalence despite new features: "These differences are not significant since they do not raise any new or potential safety risks to the user or patient and questions of safety or effectiveness."
• Performance Data Statement: "Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." (However, the criteria and results are not listed).

Ask a specific question about this device