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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 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.

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