Search Results

EzDent-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.

EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

EzDent-i v3.5 is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent-i is a patient & image management software specifically for digital dental radiography. It also provides server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment.

EzDent-i supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format. For 3D image management, it provides uploading and downloading support for dental CT Images in DICOM format. It interfaces with a 3D imaging software made by our company, the Ez3D-i (K131616, K150761, K161246, K163539, K173863, K190791, K200178, K211791, K222069, K231757) but the EzDent-i itself does not view, transfer or process 3D radiographs.

EzDent-i supports the acquisition of dental images by interfacing with OpenCV library to import the intra-oral camera images. It also supports the acquisition of CT/Panoramic/Cephalo/Intra-Oral Sensor /Intra-Oral Scanner images by interfacing with Xray capture software.

The provided text is a 510(k) summary for the EzDent-i/E2/Prora View/Smart M Viewer (v3.5) device. It asserts substantial equivalence to a predicate device (EzDent-i/E2/Prora View/Smart M Viewer v3.4). However, the document does not contain any specific acceptance criteria or details of a study proving the device meets acceptance criteria.

The "Performance Data" section (Section 10) only states: "SW verification/validation and the measurement accuracy test 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. Also we have addressed the recommendations in the most recent cybersecurity guidance, "Cybersecurity in Medical Devices Quality System Considerations and Content of Premarket Submissions"."

This statement confirms that tests were conducted and passed, but does not provide the actual acceptance criteria, the reported device performance, sample sizes, details on ground truth establishment, expert qualifications, adjudication methods, or whether MRMC/standalone studies were performed.

Therefore, based solely on the provided text, I cannot complete the requested tables and information. The document confirms that testing occurred and passed, but the specifics required to answer your questions are not present in this 510(k) summary.

Ask a specific question about this device

EzDent-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.

EzDent-i is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

EzDent-i is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent-i is a patient & image management software specifically for digital dental radiography. It also provides server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment.

EzDent-i supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format. For 3D image management, it provides uploading and downloading support for dental CT Images in DICOM format. It interfaces with a 3D imaging software made by our company, the Ez3D-i (K131616, K150761, K161246, K163539, K173863, K190791, K200178) but the EzDent-i itself does not view, transfer or process 3D radiographs.

EzDent-i supports the acquisition of dental images by interfacing with OpenCV library to import the intra-oral camera images. It also supports the acquisition of CT/Panoramic/Cephalo/Intra-Oral Sensor /Intra-Oral Scanner images by interfacing with Xray capture software.

The provided text describes a 510(k) premarket notification for a dental imaging software named EzDent-i. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, not to showcase the performance of an AI algorithm based on comparative studies. Therefore, much of the requested information regarding acceptance criteria and performance studies (especially relating to AI, human readers, and ground truth establishment) is not detailed in this document because it is not typically required for a software device demonstrating substantial equivalence by adding convenience features.

However, based on the context of the document, we can infer some details and explicitly state what is not provided.

Here's an attempt to answer your questions based on the provided text, indicating where information is not present:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating that the modified device's performance aligns with its intended use and is comparable to the predicate device.

The "Performance Data" section states: "SW verification/validation and the measurement accuracy test 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." This indicates that internal testing was performed, and the device met its internal "Pass/Fail criteria," but these specific criteria and results are not provided in this summary.

Given that this is a 510(k) for a medical image management and processing system (not an AI-driven diagnostic aid that independently identifies pathologies), the "performance" here refers to its ability to correctly acquire, view, save, load, and manipulate dental images, similar to its predicate.

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

The document does not specify any sample size for a test set in terms of patient images. The "performance data" section refers to "SW verification/validation and the measurement accuracy test," implying software-level testing rather than clinical study data on a patient image test set. No information is available regarding data provenance (country of origin, retrospective/prospective).

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 applicable and not provided. The device (EzDent-i) is described as "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." It is a viewer and manager, not an AI diagnostic tool that produces a finding requiring expert ground truth for performance evaluation in the described context. The performance verification likely focuses on technical accuracy of image display, manipulation, and data handling, not diagnostic accuracy against a ground truth.

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

Not applicable and not provided. As per point 3, there's no indication of a diagnostic test set requiring adjudication.

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 such study was mentioned or required for this 510(k) submission. This device is a general image management and processing system, not an AI-assisted diagnostic tool that would typically warrant an MRMC study to show human reader improvement with AI assistance.

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

This device is not an algorithm performing a standalone diagnostic task. It is software that provides "diagnostic tools" for viewing and interpreting images by human professionals. Therefore, a standalone algorithm performance evaluation would not be applicable or described here.

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

Not applicable and not provided. As this is not an AI diagnostic device, the concept of ground truth for diagnostic accuracy (e.g., concerning a disease or finding) is not relevant to the described performance evaluations. The "performance" relates to the software's ability to achieve its technical specifications.

8. The sample size for the training set

Not applicable and not provided. This document describes a traditional software upgrade and substantial equivalence claim, not a machine learning or AI device that would have a training set.

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

Not applicable and not provided. As per point 8, there is no mention of a training set for an AI model in this submission.

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

EzMobile is dental imaging software that is intended to provide various tools for maxillofacial radiographic imaging. These tools are available to view a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzMobile is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

EzMobile is dental imaging software that is intended to provide various tools for maxillofacial radiographic imaging. These tools are available to view a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist. EzMobile is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

The provided text is an FDA 510(k) clearance letter for EzMobile, a dental imaging software. It does not contain information about acceptance criteria for a device's performance or a study proving the device meets acceptance criteria related to diagnostic accuracy or AI performance metrics.

The clearance letter primarily addresses regulatory compliance and substantial equivalence to a predicate device. The "Indications for Use" section describes the software's intended function (viewing/saving DICOM dental images, etc.) but does not specify performance metrics or a study demonstrating their achievement.

Therefore,Based on the provided document alone, I cannot provide the requested information regarding the acceptance criteria and the study that proves the device meets them. The document is an FDA clearance letter focusing on regulatory compliance and substantial equivalence, not a performance study report.

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. 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 describes the Ez3D-i / E3 dental imaging software and its substantial equivalence to a predicate device (K173863). However, it does not contain a detailed study with specific acceptance criteria and performance metrics for the new device that would allow for a quantitative comparison in the format requested.

The document states that "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 provide the specifics of these tests, the acceptance criteria, or the reported performance.

Therefore, I cannot populate the table or provide detailed answers to most of the questions based solely on the provided text.

Here's an assessment based on the information that is available:

Acceptance Criteria and Study Details for Ez3D-i / E3

The provided documentation does not include a specific table of acceptance criteria and reported device performance for the Ez3D-i / E3. It generally states that validation and verification activities were performed and the device passed pre-determined Pass/Fail criteria. The submission focuses on demonstrating substantial equivalence to a predicate device (Ez3D-i / E3, K173863) rather than presenting a de novo performance study with quantitative metrics against specific acceptance thresholds.

Missing Information:

• A table of specific acceptance criteria.
• Quantitative reported device performance against those criteria.
• Details about the study design that would prove the device meets these criteria.

Given the information provided, many sections below cannot be fully answered.

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

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 for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text.

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 in the provided text. The document mentions that the software's results are dependent on the interpretation of "trained and licensed radiologists, clinicians and referring physicians," suggesting human expertise is involved in the clinical use, but it does not detail an expert ground truth process for a test set.

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

• Not specified in the provided text.

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

• A MRMC comparative effectiveness study is not mentioned in the provided text. The device is described as providing "diagnostic tools" and "advanced simulation functions" for use by trained medical professionals, but there's no study detailed to show improvement with or without AI assistance. The submission focuses on software functionality, not a comparative clinical trial.

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

• A standalone performance study for the algorithm is not explicitly described in the provided text in terms of quantitative metrics. The document emphasizes that the results are "dependent on the interpretation of trained and licensed radiologists, clinicians and referring physicians as an adjunctive to standard radiology practices for diagnosis." This suggests it's positioned as an adjunctive tool rather than a standalone diagnostic AI. The "verification, validation and testing activities" likely pertained to software functionality and safety rather than diagnostic accuracy as a standalone algorithm.

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

• Not specified in the provided text for any performance evaluation.

8. The sample size for the training set

• Not specified in the provided text. There is no mention of a "training set," which implies that the device, in this context, is not explicitly described as an AI/ML product that learns from data in the way typically discussed for training sets. It is a software tool with pre-programmed functions for visualization and analysis.

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

• Not applicable based on the lack of a specified "training set" in the provided text.

Ask a specific question about this device