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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 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 v3.4 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) but the EzDent-i itself does not view, transfer or process 3D radiographs. None of the changes to the predicate software are related to the 3D functions.

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 software level of concern is Moderate.

The provided document is a 510(k) summary for the EzDent-i / E2 / Prora View / Smart M Viewer software. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.

However, the document does not contain the detailed information necessary to answer all parts of your request, specifically regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

This 510(k) submission primarily focuses on demonstrating that the updated software version (v3.4) is substantially equivalent to a previous cleared version (v3.3) by highlighting that the changes are for "user convenience and do not affect the device safety or effectiveness". It therefore does not provide a comprehensive study report with quantified performance metrics against specific acceptance criteria for diagnostic accuracy, which would typically be found in direct performance studies for devices with diagnostic claims.

Here's what can be extracted and what 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 (e.g., country of origin of the data, 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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • The Indications for Use state the device is "meant to be used by trained medical professionals such as radiologist and dentist." This implies the target users, but not the experts for ground truth.

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

• Adjudication Method: 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

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The device is described as "dental imaging software that is intended to provide diagnostic tools" and its 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 is a viewing and processing tool, not a diagnostic AI that would typically undergo an MRMC study to show improvement in human reader performance.

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

• Standalone Performance Study: No, a standalone performance study is not described. Given the device's function as an image management and processing system used "as an adjunctive to standard radiology practices for diagnosis," it is not presented as an AI algorithm providing standalone diagnoses.

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

• Type of Ground Truth: Not specified, as specific performance tests against diagnostic ground truth are not detailed. The performance data section broadly mentions "SW verification/validation and the measurement accuracy test were conducted," implying functional and technical testing rather than a clinical performance study with established ground truth for diagnostic accuracy.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. The document describes software with various image processing and management features, rather than a machine learning or AI algorithm that would require a distinct "training set."

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

• Ground Truth for Training Set: Not applicable/Not specified, as no training set for a machine learning model is mentioned.

Summary of what the document implies about performance testing:

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 Ewoosoft performed internal validation testing to ensure the software met its specified functional and technical requirements (e.g., correct image display, accurate measurements for linear distance and angle, proper functioning of new features like "Image Share" and "IO sensor image Preview"). However, these are not detailed clinical performance metrics for diagnostic efficacy or accuracy that would typically be associated with AI-driven diagnostic devices. Since the device is presented as substantially equivalent to a predicate device for managing and processing images, the focus of the 510(k) is on the safety and effectiveness of the software updates rather than demonstrating novel diagnostic performance.

Ask a specific question about this device

The EzDent-i /E2 /ProraView/ Smart M Viewer 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.

The EzDent-i F2 /ProraView/ Smart M Viewer 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.

The EzDent-i / E2 / Prora View / Smart M Viewer v.3.3 is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. The subject device 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.

It also 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) but does not view, transfer or process 3D radiographs.

The subject device 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.

This document describes a 510(k) premarket notification for the EzDent-i / E2 / ProraView/ Smart M Viewer, a dental imaging software. The submission aims to demonstrate substantial equivalence to a previously cleared version of the same software (EzDent-i / E2 / Prora View / Smart M Viewer v.3.2, K211795).

Based on the provided information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a pass/fail format. Instead, it relies on a statement that "The device passed all of the tests based on pre-determined Pass/Fail criteria." The study's focus was on demonstrating that modifications made to the software "do not raise the questions of safety or effectiveness" and that the newer version is substantially equivalent to the predicate device.

The reported device performance, in terms of meeting criteria, is implicitly described as:

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

The document states that "SW verification/validation and the measurement accuracy test were conducted." However, it does not provide any details regarding:

• The specific sample size (e.g., number of images, number of cases) used for the test set.
• The data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

This information is not provided in the document. The document mentions that the software's diagnostic 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, it does not specify how ground truth was established for the performance testing.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth for the test set.

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

An MRMC comparative effectiveness study was not performed or reported in this submission. The study focuses on demonstrating substantial equivalence of the modified software version to its predicate through software verification/validation and measurement accuracy testing, rather than evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study focused on the algorithm's performance without human-in-the-loop interaction was performed implicitly through the "SW verification/validation and the measurement accuracy test." These tests are typically designed to assess the software's intrinsic functionalities and accuracy parameters independently. The submission indicates that these tests were conducted and passed. However, specific metrics (e.g., sensitivity, specificity, AUC) for diagnostic capabilities are not provided, as the device is characterized as a "medical image management and processing system" with "diagnostic tools," meaning it is an adjunctive tool for image interpretation by clinicians.

7. Type of Ground Truth Used

The type of ground truth used for the "SW verification/validation and the measurement accuracy test" is not explicitly stated. Given the nature of a "medical image management and processing system" and its function of enabling trained professionals to "view and interpret" images and provide "diagnostic tools," the ground truth for measurement accuracy tests would likely involve precisely measured objects or features within reference images. For software functionality, it would involve confirming that features operate as intended based on predefined specifications. Pathology or outcomes data are not mentioned as being used for ground truth.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This submission describes an updated version of existing software, and the evaluation focuses on comparing it to a predicate device rather than on the development and training of a new AI algorithm.

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

As no training set is mentioned, information on how its ground truth was established is not applicable/not provided in this document.

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

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.

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 & 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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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) 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 describes a 510(k) premarket notification for a dental imaging software called EzDent-i (also referred to as E2 and ProraView). The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device. As such, the document focuses on comparing the new device to the predicate device rather than detailing specific performance studies with acceptance criteria for diagnostic accuracy.

Therefore, based on the provided text, I cannot provide a table of acceptance criteria and reported device performance related to diagnostic accuracy because such information is not present. The document focuses on performance related to functionality and reliability of the software.

Here's an analysis addressing the other points based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the provided text does not contain specific acceptance criteria or reported device performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity, AUC) for the EzDent-i software. 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."

This indicates that internal performance tests were conducted for functionality and reliability, and the device met its own pre-determined pass/fail criteria for these aspects. However, further details on these criteria or the results are not provided.

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

The document does not specify any sample size used for a test set (in the context of evaluating diagnostic performance) or the data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned refers to "performance, functionality and reliability characteristics" of the software itself.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish a ground truth for any diagnostic performance test set. The software is described as providing "diagnostic tools," but its own diagnostic accuracy is not explicitly evaluated in the provided text.

4. Adjudication Method

No adjudication method is mentioned, as there is no described diagnostic performance study involving human readers or expert panels.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The document focuses on the software's features and its substantial equivalence to a predicate device, not on how human readers perform with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study for the algorithm's diagnostic accuracy is not mentioned. The "performance data" refers to the verification, validation, and testing of the software's functionality and reliability.

7. Type of Ground Truth Used

No type of ground truth (e.g., expert consensus, pathology, outcomes data) is mentioned, as no diagnostic performance study is described. The "ground truth" for the software's own functionality and reliability would relate to its adherence to design specifications.

8. Sample Size for the Training Set

No sample size for a training set (relevant for machine learning algorithms) is mentioned. The description of the device's technological characteristics does not indicate the use of AI/machine learning that requires a training set in the typical sense. It describes features like "image processing functions including adjustment of brightness and contrast" and "measurement function of length and angle," which are generally rule-based or conventional image processing techniques, not typically requiring large training datasets for their core function.

9. How Ground Truth for Training Set Was Established

Since no training set is mentioned, the method for establishing its ground truth is also not described.

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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 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 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

The provided text is a 510(k) summary for the Ez3D-i / E3 dental imaging software. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the detailed performance data, acceptance criteria, or study specifics requested in your prompt.

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." (Page 5)

This statement indicates that performance testing was performed and passed, but it does not provide any specific acceptance criteria, reported device performance metrics, sample sizes, data provenance, ground truth establishment, or details about comparative effectiveness studies.

Therefore, I cannot fulfill your request for the specific acceptance criteria and study details based purely on the provided text. The document is a regulatory submission summary, not a detailed technical report of the validation study.

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 and save 2D image files, 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) 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. The summary focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study evaluating the device against specific acceptance criteria for diagnostic performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set information is not available within this document.

The document primarily states:

• Performance Data: "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."
• Conclusion: "The new device and 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 modifications are validated through system level test."

This indicates that internal verification and validation against pre-determined criteria were performed for functionality and reliability to support substantial equivalence, but it does not provide the specific diagnostic performance metrics or study design typically found in a clinical performance study.

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