Search Results

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 and simulation program developed by Ewoosoft. It is of Moderate level of concern. 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) simulations. The analyzed results are saved in chart format so that the user can easily store and track the treatment and records of each patient.

The provided text, K220003, is a 510(k) summary for a software device called "EzOrtho v1.3." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (EzOrtho v1.2) rather than presenting a performance study with acceptance criteria and a detailed study design.

Therefore, the requested information, specifically regarding acceptance criteria, a detailed study proving device performance against these criteria, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and ground truth types, is not explicitly available in the provided document.

The document states:

• "EzOrtho v1.3 described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device." (Page 6)
• "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." (Page 6)
• "The modifications are changes in PC system requirement information, upgrading the SETTINGS tab (font size change option for analysis chart), upgrading the PATIENT Tab (reset to original DICOM pixel spacing), upgrading the VIEWER Tab (change layouts in presentation mode), upgrading the ANALYSIS Tab (exporting analysis chart), upgrading the PRACTICE Tab (UI upgrade and recurrence option).These differences are not significant since they are additional features for user convenience and do not raise the questions of safety or effectiveness." (Page 6)
• "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." (Page 7)

This indicates that the focus of the submission was on validating the non-significant changes between versions to ensure they did not negatively impact the established safety and effectiveness. The "measurement accuracy test" mentioned is likely a part of the software verification/validation, but its specific methodology, acceptance criteria, and detailed results are not provided in this summary.

In summary, the document does not contain the detailed performance study information requested. It primarily relies on the predicate device's established performance and demonstrates that the modifications in EzOrtho v1.3 do not alter its fundamental functionality or safety/effectiveness profile, hence requiring less extensive clinical performance data than a novel device might.

Ask a specific question about this device

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 and simulation 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) simulations. The analyzed results are saved in chart format so that the user can easily store and track the treatment and records of each patient.

The provided text is a 510(k) summary for the EzOrtho device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets them.

Specifically, the document 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." (Page 6)

This confirms that tests were done and acceptance criteria existed, but the document does not provide the specific "predetermined Pass/Fail criteria" (acceptance criteria) nor the detailed "measurement accuracy test" results (reported device performance). It also does not elaborate on the specific study details such as sample size, data provenance, expert involvement, or ground truth establishment.

Based on the available information, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This information is not explicitly detailed in the provided 510(k) summary. The document states that a "measurement accuracy test" was conducted and "The device passed all of the tests based on pre-determined Pass/Fail criteria." However, the specific criteria (e.g., tolerance for linear distance measurements, angular measurements) and the numerical results are not included.

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

This information is not provided in the document.

• Sample Size for Test Set: Not specified.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.

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

This information is not provided in the document for the "measurement accuracy test." The document mentions that the software's results are "dependent on the interpretation of trained and licensed practitioners or dentists" (page 4, Indications for Use), but this refers to the clinical use of the device, not the ground truth establishment for the validation study itself.

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:

A MRMC comparative effectiveness study is not mentioned in the document. The EzOrtho device is described as a "Medical Image Management and Processing System" that assists in orthodontic treatment by providing analysis and simulation tools, and its results are "dependent on the interpretation of trained and licensed practitioners or dentists." It does not describe an AI assistance feature for human readers within a diagnostic workflow in the context of improving reader performance, but rather a tool for analysis and simulation.

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

The document describes "SW verification/validation and the measurement accuracy test" as being conducted. While these tests evaluate the algorithm's performance, the context does not explicitly state if this was a "standalone" performance evaluation in the sense of a diagnostic performance claim without human interpretation. Given the device's description and indications for use ("Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists."), it suggests the device is an assistive tool, not a standalone diagnostic device. The "measurement accuracy test" would evaluate the accuracy of the measurements generated by the software itself, which is a form of standalone evaluation of that specific function.

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

This information is not explicitly detailed in the document for the "measurement accuracy test." For a "measurement accuracy test" in imaging, ground truth is typically established by highly accurate manual measurements (e.g., by experts) or by phantoms with known dimensions. The document does not specify how the ground truth was established for the measurements.

8. The sample size for the training set:

The document makes no mention of a "training set," implying that the device's functionality (measurement and simulation) is likely based on defined algorithms and parameters rather than a machine learning model that requires a training set. If there were a machine learning component, information about training data would typically be included.

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

Since no training set is mentioned (see point 8), this information is not applicable/provided.

In summary: The provided 510(k) letter confirms that the EzOrtho device underwent "measurement accuracy tests" and passed "pre-determined Pass/Fail criteria" for its performance, functionality, and reliability. However, this regulatory summary does not contain the detailed clinical study report or technical specifications that would provide the specific quantitative acceptance criteria, the actual numerical performance results, sample sizes for testing or training, details on ground truth establishment, or any information about comparative effectiveness studies with human readers. This level of detail is typically found in the full submission, not necessarily in the publicly available 510(k) summary letter.

Ask a specific question about this device

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 and simulation 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) simulations. The analyzed results are saved in chart format so that the user 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 features for making schedules and managing patient appointments. In addition. EzOrtho enables the users to import images from EzDent-i made by our company, 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 features support easier tracing.
• Establishing Treatment Plans ● The Morphing feature enables the user to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables the user 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 after surgery changes visually, and the Gallery feature plays a slide show with multiple images of patients.

The provided text is a 510(k) summary for the medical device EzOrtho. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any performance data from a specific study that demonstrates the device meets particular acceptance criteria. The "Performance Data" section only 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." This is a general statement and does not provide the specific details required to answer your questions about acceptance criteria and a study proving their fulfillment.

Therefore, I cannot populate the table or provide the detailed information requested regarding sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided document.

To answer your questions, I would need a section detailing a specific clinical or performance study, including:

• Specific performance metrics and their acceptance thresholds.
• The actual results of the device against those metrics.
• Details about the dataset used (size, type, origin).
• Information about the ground truth establishment process (number/qualifications of experts, adjudication).

Without this specific performance study data, I can only provide general information based on the document's structure, which states that performance, functionality, and reliability characteristics were verified and validated, and all tests passed their pre-determined criteria.

Ask a specific question about this device

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.

Ask a specific question about this device