(202 days)
iOrtho is intended for use as a medical front-end device providing tools for management of orthodontic cases, systematic inspection, detailed analysis, treatment simulation and virtual applians (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of iOrtho requires the user to have the necessary training and domain knowledge in the practice of orthodonties, as well as to have received a dedicated training in the use of the software.
iOrtho (hereafter referred to as "Proposed Device") includes modifications to the currently marketed software included in K203688, cleared October 8, 2021 (hereafter referred to as "Reference Device"). The Proposed Device is an orthodontic appliance design and treatment simulation software is for use by dental professionals to aid in diagnosis and design solutions for patients. Digital scans (3D) of a patient's dentition can be loaded into the software and the dental professional can then create treatment plans for each individual patient and their needs. The system can be used to fabricate 3D dental models using standard stereolithographic (STL) files for use in 3D printers. These models can then be used as a template for thermoforming aligners or retainers by Angel Align technicians.
The provided text is a 510(k) summary for the iOrtho device. It describes the device, its intended use, and compares it to predicate and reference devices to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria or a specific study that proves the device meets those criteria in detail.
The summary states:
"Utilizing FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2015) the Proposed Device, iOrtho underwent appropriate integration, verification, and validation testing. The software passed the testing and performed per its intended use."
And:
"The software has been designed, integrated, verified, and validated in accordance with IEC 62304-Medical device software – software life cycle processes."
These statements confirm that testing was performed and passed, and that it followed relevant standards and guidance. However, the document does not provide the specific acceptance criteria, the detailed results (e.g., in a table), sample sizes, ground truth establishment methods, or expert qualifications that are typically found in a clinical or performance study summary.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study, as this information is not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence through comparison of specifications and general statements about passing validation testing, rather than presenting a detailed performance study with specific metrics and methodologies.
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.