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510(k) Data Aggregation
(155 days)
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):
| Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Automatic Cephalometric Tracing | The automatic cephalometric tracing feature should demonstrate acceptable accuracy. | The validation test concluded that the auto feature demonstrates accuracy. (Specific performance metrics like mean absolute error or agreement rates are not provided in this summary.) |
| Overall Software Performance | The device passed all tests based on pre-determined Pass/Fail criteria for software verification/validation and measurement accuracy. | The device passed all of the tests. |
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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