Search Results

Web Ceph is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO (Visual Treatment Objective) 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. The device is only for the use of patients above 7 years old.

WebCeph is a 2D orthodontic analysis program. It manages patient information and images for orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, profilograms, superimpositions, and VTO (visualized treatment objective) and STO (surgical treatment objective). The analyzed results are saved in chart format so that the users can easily store and track the treatment and records of each patient. This device is designed to provide a simple and straightforward user interface.

WebCeph is used for registering orthodontic medical images and managing the patient information through the features of making schedules and managing patient appointments. This software receives image files (JPG, BMP, PNG) as input source and enables the users to easily calibrate the size of the image or arrange multiple film/photo images.

The feature of anatomical landmark detection support more accurate and easier tracing by enabling the user precisely to adjust the position of the detected landmarks.

After image alignment, orthodontic treatment simulation and Maxillo-facial surgical planning simulation can be performed. The Morphing feature enables the dentist user to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables the dentist user to establish a treatment plan by comparing photos before and after the treatment.

Cephalometric analysis results are provided as a report. The report can be saved in PDF file or Excel file format. For the evaluation of treatment progress, the software automatically superimposes the lateral cephalographic image.

This software 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 provided text is a 510(k) summary for the WebCeph device. It outlines the device description, indications for use, comparison to a predicate device (EzOrtho), and states that performance data was collected. However, it does not contain any specific acceptance criteria or performance study results for the device itself.

The "Performance Data" section merely 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 is a high-level statement and lacks the detailed information requested in the prompt.

Therefore, I cannot provide the requested table, sample sizes, expert qualifications, or details about MRMC or standalone studies because this information is not present in the provided document.

To answer your request, I would need a section of the 510(k) submission that specifically details the clinical or performance study conducted to demonstrate the device's accuracy and effectiveness against defined acceptance criteria. This typically includes:

• Specific performance metrics: What was measured (e.g., accuracy of landmark detection, precision of measurements)?
• Acceptance criteria: What was the numerical threshold for acceptable performance (e.g., landmark detection within X mm of ground truth, angular measurements within Y degrees)?
• Study design: How was the data collected and analyzed?
• Results: The actual reported device performance against the acceptance criteria.
• Ground truth establishment details: How was the "true" value determined for the test cases?
• Training and test set specifics: Sizes, data characteristics.

Without this information, any attempt to fill out the table or answer the questions would be speculative and inaccurate based only on the provided text.

Ask a specific question about this device