(27 days)
Otrho Vision software is indicated for use by orthodontists for image analysis, simulation, profilogram, growth forecast, 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.
OrthoVision is a 2D orthodontic analysis and simulation program created by EWOOSOFT. OrthoVision manages patient information and images during orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, growth forecasts, profilograms, superimpositions, and VTO/STO simulations. The analyzed results are saved in chart format so that you can easily store and track treatment and records of each patient.
The provided text is a 510(k) summary for the OrthoVision software. It asserts substantial equivalence to a previous version of the same device. As such, it does not contain the detailed study information typically found in a De Novo or full PMA submission where a new device's performance is rigorously tested against acceptance criteria.
The document 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." However, it does not specify what those acceptance criteria were, what tests were conducted, or the results of those tests in a quantifiable manner.
Therefore, the requested information, specifically acceptance criteria and a study proving the device meets them, is not present in the provided text.
Here's a breakdown of the specific points missing:
- A table of acceptance criteria and the reported device performance: This is not provided. The document only states that tests were conducted and passed.
- Sample sized used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method: Not provided.
- 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 provided. This type of study is typically done for AI/CAD devices aiming to improve human performance. OrthoVision is described as an "image analysis, simulation, profilogram, growth forecast, VTO/STO and patient consultation" software, whose results are "dependent on the interpretation of trained and licensed practitioners or dentists," suggesting it's a tool for practitioners rather than a direct diagnostic AI that would be subject to MRMC studies demonstrating improvement over human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. Given its description, a standalone performance study in the context of a new diagnostic algorithm is not explicitly relevant here as it's an analysis and simulation tool for interpretation by a human.
- The type of ground truth used: Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).