Search Results

Indicated for use in alignment of teeth through orthodontic treatment of malocclusion.

The Proposed Device is indicated for use in the alignment or mixed dentition teeth through orthodontic treatment of misalignment and malocclusion, with 20 to 22 hours of daily wear for at least 10 days. The Proposed Device allows the option of forward repositioning of the mandible to a more optimal bite profile.

This premarket notification is submitted to notify the FDA of Wuxi EA Medical Technologies' intent of changes to the Clear Aligner (hereafter referred to as "Proposed Device") to the currently marketed reference device's, Clear Aligner (K203688, cleared October 8, 2021) (hereafter referred to as "Reference Device") indications for use to include mixed dentition, a wear time of at least 10 days, and mandibular repositioning features.

The Proposed Device consists of multiple stages of thermoformed plastic aligners designed to be worn in sequence to facilitate the movement of a patient's teeth to the final desired treatment position. The sequential stages of aligners introduce incremental move teeth by way of gentle continuous force and reposition the mandible to achieve a more optimal bite profile. The aligners are to be worn 20 to 22 hours a day and are to be removed for cleaning. Patients can be prescribed with more than one aligner of different materials within a single stage.

The Proposed Device is designed from digital scans of a patient's dentition submitted by a dental health professional (e.g. dentist or orthodontist). Using the scan, sequential stages of dental models are designed and approved by a physician prior to physical manufacturing. The Proposed Device includes mandibular repositioning features known as "A6" on each upper and lower aligner. A6 is intended for use in patients with growing mandibles presenting with retrognathic Class II malocclusions in permanent dentition or stable late mixed dentition.

Once the treatment plan is reviewed and approved by a dental health professional, the 3D model of each stage from the treatment plan is manufactured by 3D printed models are then thermoformed over with a suitable dental thermoplastic sheet. The final manufactured aligner stages are then delivered to the patient. The patients' dental health professional then monitors their treatment from the placement of delivered initial aligner stage to the final aligner stage.

The provided text is a 510(k) summary for a medical device (Clear Aligner) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through a rigorous test set evaluation usually seen with AI/ML-enabled devices.

This document describes a "special 510(k)" submission, which is typically used for modifications to a company's own already-cleared device where the modification does not raise new questions of safety and effectiveness. In this case, the modifications are to the indications for use (adding mixed dentition, shorter wear time, and mandibular repositioning features) and material options.

The "clinical performance testing" section states: "Retrospective clinical data has been provided the Proposed Device. The data collected for the study showed that successful alignment of teeth through orthodontic treatment of misalignment and malocclusion with at 20 to 22 hours of daily wear for at least 10 days was achieved when using the Proposed Device."

This statement is very general and does not provide the quantitative details needed to fill out the requested table or address most of the specific questions about acceptance criteria and study methodology. It mentions "retrospective clinical data" and "successful alignment," but lacks specific metrics, sample sizes for the test set, ground truth creation details, expert qualifications, or MRMC study information.

Therefore, I cannot provide the requested information from the given text. The document focuses on demonstrating substantial equivalence to a predicate device based on similarities in indications for use, technological characteristics, and non-clinical performance data, rather than presenting a detailed performance study against specific acceptance criteria for a novel AI/ML algorithm.

Ask a specific question about this device

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.

Ask a specific question about this device