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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 & K163533 & K173863 & K190791) 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 images by interfacing with X-ray capture software.

EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are;

• · Easy and convenient data search function for patient information and clinical images
• · Various image viewing format for 2D dental images
• Various image processing functions including adjustment of brightness and contrast for images
• · Measurement function of length and angle for 2D images
• · Dental implant simulation for treatment planning and effective patient consultation
• · Crown simulation for more effective patient consultation
• · Print function supporting various viewing output format

The provided text is a 510(k) summary for the EzDent-i/E2/Prora View/Smart M Viewer dental imaging software. While it states that performance data was collected and the device "passed all of the tests based on pre-determined Pass/Fail criteria," it does not provide specific details about the acceptance criteria, the study itself, or the quantitative performance metrics.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The document focuses on demonstrating substantial equivalence to a predicate device based on similar intended use and technical characteristics, with modifications described as "additional features for user convenience" that "do not raise the questions of safety or effectiveness."

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. (The applicant is based in Republic of Korea, but this does not confirm the data origin).
• Retrospective or Prospective: Not specified.

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

• Not specified. The document indicates that the software's tools are "meant to be used by trained medical professionals such as radiologist and dentist" 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." However, this pertains to the intended clinical use, not the ground truth establishment for software validation.

4. Adjudication method for the test set:

• Not specified.

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:

• Not specified. The device is described as "dental imaging software that is intended to provide diagnostic tools" and offers "various image processing functions." It is not presented as an AI-powered diagnostic aid that would typically undergo an MRMC study to show human reader improvement with AI assistance. It is classified as "Picture archiving and communications system" (PACS).

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

• Not explicitly stated. Given its classification as PACS software with "diagnostic tools" and "image processing functions," some standalone performance tests would be expected (e.g., accuracy of measurement tools, image processing fidelity), but no details are provided.

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

• Not specified.

8. The sample size for the training set:

• Not applicable as this documentation describes a PACS/imaging software, not an AI/ML algorithm that requires a separate training set. The changes described are primarily feature additions and graphical updates.

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

• Not applicable for the same reason as above.

In summary, the provided 510(k) letter focuses on demonstrating substantial equivalence to a predicate device, primarily through a comparison of intended use and technical specifications. It makes a general statement about performance data collected and tests passed, but it lacks the detailed quantitative information that would typically be available for a device with specific performance claims, especially for AI/ML-driven diagnostics.

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EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.

EzOrtho is a 2D orthodontic analysis program developed by Ewoosoft. EzOrtho manages patient information and images for orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, profilograms, superimpositions, and VTO (visualised treatment objective) and STO (surgical treatment objective). The analyzed results are saved in chart format so that you can easily store and track the treatment and records of each patient.

EzOrtho is designed to provide a simple and straightforward user interface.

• Managing Patients and Registering Images EzOrtho offers powerful features related to making schedules and managing patient appointments. In addition, EzOrtho enables you to import images from EzDenti(K190087, K172364, K163533, K161117, K150747), Explorer, or a scanner and easily calibrate the size of the image or arrange multiple film/photo images.
• . Analyzing and Tracing Images The Landmark Voice Guide and the improved Landmark Input Interface support more accurate and easier tracing.
• . Establishing Treatment Plans The Morphing feature enables you to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables you to establish a treatment plan by comparing photos before and after the treatment.
• . Assisting with Patient Consultation EzOrtho provides features to facilitate understanding and communication between doctors and patients during consultation. For example, the Superimposition feature displays the changes visually due to the treatment and the Gallery feature plays a slide show with multiple images of patients.

The EzOrtho device's acceptance criteria and the study proving it meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document focuses on establishing substantial equivalence to a predicate device (OrthoVision v2.1) rather than defining granular acceptance criteria for specific performance metrics of the new features. However, for the newly added "automatic cephalometric tracing feature," a validation test was performed to evaluate its accuracy.

Acceptance Criteria (Implied for Automatic Cephalometric Tracing):

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

• Test Set Sample Size: The document does not specify the exact sample size (number of images or cases) used for the "validation test to evaluate the accuracy of this auto feature."
• Data Provenance: Not specified in the document.

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

Not specified in the document.

4. Adjudication Method for the Test Set

Not specified in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not explicitly mentioned or described for the EzOrtho device. The focus of the performance data section is on the device's own accuracy and software validation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation of the "automatic cephalometric tracing feature" was done. The document states: "We performed the validation test to evaluate the accuracy of this auto feature." This implies an assessment of the algorithm's performance on its own. It also states that "The users can still adjust the points manually when necessary," indicating that while standalone performance was evaluated, the device is ultimately intended for human-in-the-loop use.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the "automatic cephalometric tracing feature," the type of ground truth used is not explicitly stated. However, given the context of cephalometric analysis, it is highly probable that the ground truth would have been established by:

• Expert Tracings/Measurements: Manual tracings and measurements performed by one or more qualified orthodontic experts.

8. The Sample Size for the Training Set

Not specified in the document. The document details a 510(k) submission for a software device, and while it mentions an "auto feature," it does not provide details about model training or the size of any training sets.

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

Not specified in the document. As no information on a training set is provided, the method for establishing its ground truth is also not mentioned.

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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 & K163533 & K173863) 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 images by interfacing with X-ray capture software.

EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are;

• · Easy and convenient data search function for patient information and clinical images
• · Various image viewing format for 2D dental images
• · Various image processing functions including adjustment of brightness and contrast for images
• · Measurement function of length and angle for 2D images
• · Dental implant simulation for treatment planning and effective patient consultation
• · Crown simulation for more effective patient consultation
• · Print function supporting various viewing output format

The provided text is a 510(k) summary for the EzDent-i / E2 / Prora View dental imaging software. Based on the information given, here's an analysis addressing your questions:

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

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."
• "The subject device and the unmodified device are substantially equivalent, having the same indications for use and functionalities like operation software, computer platform, picture archiving and communication format, image format, image processing features, windowing. image edit, measurements and manipulation."
• "The differences are that the subject device has changes in PC System Requirement Information Change, Settings upgrade (Annotation, Privacy Policy, adding Help Document, VIEWER tab upgrade (Export Image with Overlay, Saving as IO Sensor Image) and adding SERVICE tab. These differences are not significant since they are additional features for user convenience and do not raise the questions of safety or effectiveness."

Crucially, this 510(k) summary does not provide a specific table of quantitative acceptance criteria or detailed performance metrics. The core of this submission is to demonstrate substantial equivalence to a previously cleared device (EzDent-i / E2 / ProraView, K172364). The "performance data" section only states that testing was done and passed pre-determined criteria, but it does not specify what those criteria were (e.g., minimum accuracy, sensitivity, specificity for a diagnostic task). The changes appear to be primarily related to software features, user interface, and system compatibility, rather than fundamental diagnostic algorithm performance.

Therefore, a table of acceptance criteria and reported device performance specific to diagnostic accuracy (e.g., AUC, sensitivity, specificity) cannot be extracted from this document because it's not a de novo submission or a significant change that would necessitate such detailed performance validation for diagnostic claims.

2. Sample size 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 the sample size used for any test set or the provenance of the data (country of origin, retrospective/prospective). Given that the submission focuses on substantial equivalence based on feature updates rather than new diagnostic claims, it's unlikely a large-scale diagnostic performance study with specific sample sizes was conducted. The testing likely focused on functional verification and validation of the new software features.

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)

This information is not provided in the document. Since the submission is not focused on validating a new diagnostic algorithm's performance against ground truth, there's no mention of expert-established ground truth or expert qualifications used for such a test.

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

This information is not provided in the document.

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 (MRMC or otherwise demonstrating human reader improvement with AI assistance) is mentioned or implied in this 510(k) summary. The device's purpose is "to provide diagnostic tools" and is "meant to be used by trained medical professionals such as radiologist and dentist" for viewing and interpreting images. It is not described as an AI-powered diagnostic aid that assists human readers.

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

This document does not indicate that a standalone algorithm performance study was conducted. The device is described as software that provides tools for human interpretation, not an autonomous diagnostic algorithm.

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

Since the document does not detail a diagnostic performance study, the type of ground truth used is not specified.

8. The sample size for the training set

This information is not provided. The device is described as "dental imaging software," and it's unclear if it even employs machine learning/AI models that would require a "training set" in the conventional sense for diagnostic tasks. The changes described are primarily software features and compatibility updates.

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

Not applicable, as no information about a training set or its ground truth establishment is provided.

Summary of what's provided for acceptance criteria and proof of meeting them:

The 510(k) submission for EzDent-i / E2 / Prora View (K190087) focuses on demonstrating substantial equivalence to its predicate device (K172364) following software updates. The acceptance criteria described are primarily functional:

• The device retains the same indications for use.
• The device maintains the same functionalities as the predicate, including image acquisition, viewing, saving, loading DICOM files, image processing features (brightness, contrast, measurement), and simulation tools.
• New features (PC system requirement changes, settings upgrades, viewer tab upgrades, service tab) are deemed "additional features for user convenience" and do not raise new questions of safety or effectiveness.
• "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."

The proof of meeting those criteria is presented as the statement that "the device passed all of the tests based on pre-determined Pass/Fail criteria" and the FDA's ultimate determination of substantial equivalence. The document does not disclose the specific quantitative criteria or the detailed results of those tests (e.g., specific error rates, precision, or recall for any diagnostic task). This is typical for a 510(k) submission based on substantial equivalence for software updates, where the primary concern is that the changes do not adversely affect existing validated functionality and safety.

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 & K163533) 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 images by interfacing with X-ray capture software.

EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are;

• · Easy and convenient data search function for patient information and clinical images
• · Various image viewing format for 2D dental images
• · Various image processing functions including adjustment of brightness and contrast for images
• · Measurement function of length and angle for 2D images
• · Dental implant simulation for treatment planning and effective patient consultation
• · Crown simulation for more effective patient consultation
• · Print function supporting various viewing output format

Based on the provided text, the device in question is the EzDent-i / E2 / ProraView dental imaging software.

Here's the information regarding its acceptance criteria and the study that proves it:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds) for the EzDent-i software. Instead, it refers to general performance and safety verification.

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

The document does not specify a sample size for a test set in terms of patient cases or images. It mentions "verification, validation and testing activities" but does not detail the nature or size of these tests.

The data provenance (country of origin, retrospective/prospective) is not provided in the text.

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

The document does not provide any information about the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it discuss the effect size of AI assistance on human readers.

6. Standalone Performance Study

The document describes a standalone performance assessment of the software's functionality and technical characteristics. It 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." This indicates that the algorithm/software itself was tested for its intended functions. However, it does not provide quantitative results in terms of diagnostic metrics.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any testing. Given it's a dental imaging software for viewing and interpreting DICOM images, the "ground truth" for its functionality testing would likely involve verification against expected image displays, processing outcomes, and measurement accuracy, but no specific method like "expert consensus" or "pathology" is detailed for a diagnostic evaluation.

8. Sample Size for the Training Set

The document does not provide any information about the sample size used for a training set. This is consistent with the device being primarily an image management and viewing software rather than one performing automated diagnostic interpretations with AI/ML that typically require large training datasets.

9. How Ground Truth for the Training Set Was Established

Since no training set is mentioned in the context of AI/ML, the document does not describe how ground truth for a training set was established.

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