Overview and General Information

Device Operation

Medit Orthodontic Suite (previously known as Progressive Orthodontics) is an innovative app (prescription only consistent with FDA 21 CFR 801.109) that enables dental professionals to generate realistic and reproducible simulations for the most common orthodontic treatments in minutes. Utilizing an intraoral scan and optional cephalometric X-ray and identifying a few basic landmarks, the app will instantly display the anticipated outcome, encompassing 3 to 9 common treatment options for each case.

🔎Note

For more details, please see the Data Management, User Interface, and Workflow chapters below.

Intended Use and Disclaimer

The software is meant to be used as a visual aid during patient consultations by utilizing the Data Validation Analysis method. The generated simulation results should not be used as the sole source of healthcare guidance. Medit does not take responsibility for any miscommunication or improper use of the software and is not liable to either the user or the patient for any decisions or actions taken in reliance on the information given by the software.

The user assumes full responsibility for the following:

• generated results and their further interpretation and communication to the patient;

• informing the patients that the results produced by the software may not be precise or reliable;

• actions and treatment decisions based on the generated results.

⚠️Caution

This software application does not modify the patient's anthropometric scan data, which remains accessible to health care professionals, as depicted through the Medit Scan software's 3D graphical representation tools.

⚠️Caution

Medit Orthodontic Suite has integration with the SmileStream services (for coaching). Please note that Medit is not responsible for any issues related to the performance or quality of those services. For inquiries or problems, please contact the SmileStream support team.

Indication of Use

The Medit Orthodontic Suite app is indicated for use as a front-end software tool for the management of orthodontic models, systematic inspection, detailed analysis, treatment simulation, and virtual appliance design options, which may be used for sequential aligner trays or retainers. These applications are based on 3D scans 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 the program requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have dedicated training in the use of the software.

Target Users

The target user group for this software is dentists and dental professionals working in dental clinics practicing orthodontics.

Warnings

• Federal Law restricts the use of this software to dentists or licensed dental professionals.

• Orthodontic treatments can cause discomfort, especially after adjustments. Patients may experience sore teeth and gums.

• Long-term orthodontic treatment can lead to root resorption, where the roots of the teeth shorten.

• Braces can make it harder to maintain oral hygiene, increasing the risk of cavities, gum disease, and decalcification.

• Successful orthodontic treatment often requires patient compliance with wearing appliances and attending regular appointments.

Precautions

• The use of the Medit Orthodontic Suite app requires the user to have the necessary training and domain knowledge in orthodontics and to have received dedicated training in using the software.

• This is a software-only device. Physical outputs such as aligners are FDA-regulated medical devices and should be fabricated by manufacturers who have premarket clearance and are registered and listed with the FDA.

• Before utilizing the app, complete a medical history review to identify any conditions that might complicate treatment, such as bleeding disorders, heart conditions, or diabetes.

• Ensure that the patient has regular dental check-ups to monitor oral health throughout treatment.

• Ensure patients involved in contact sports use mouthguards to protect both their braces and teeth from injury.

Contraindications

The software should not be used to generate simulations for patients who have

• Active Disease: Orthodontic treatment is contraindicated in patients with active oral disease due to the risk of exacerbating the condition. Periodontal disease, dental caries, and endodontic/periapical diseases must be resolved before starting orthodontic treatment.

• Severe Bone Loss: Significant bone loss around the teeth can make orthodontic treatment unfeasible as it can compromise tooth stability.

• Severe TMJ Disorders: Severe temporomandibular joint (TMJ) disorders may worsen with orthodontic treatment and should be carefully evaluated.

• Certain Systemic Conditions: Conditions such as uncontrolled diabetes, certain heart conditions, and osteoporosis may contraindicate orthodontic treatment due to increased risks.

• Poor Oral Hygiene: Patients who are unable or unwilling to maintain proper oral hygiene may not be suitable candidates for orthodontic treatment due to the high risk of complications.

Impact on Manual Decisions

There is no impact on manual decisions, as the dentist makes all the decisions based on the information and options provided by the app.

Off-the-shelf Software

No off-the-shelf software is used.

AI/ML Use

The use of AI/ML is limited to identifying the points on the cephalometric x-ray. The related algorithms are locked to provide the same results each time the same input is applied to it and does not change with use.

Interoperability and Interfaces

Interoperability with a wide range of 3D software is achieved by supporting standard formats such as STL, OBJ, and PLY, as well as our own meditMesh format. The Medit Orthodontic Suite app is a separate and independent piece of software from the Medit scanner, and there is no direct user interface between the two. The app only receives path information for STL files using internally defined APIs via Medit Link and the Inter-Process Communication (IPC) protocol.

Cybersecurity Safety

Cybersecurity level: Level 3 (High)

The Medit Orthodontic Suite app employs robust cybersecurity measures to protect patient data confidentiality, integrity, and availability. It complies with industry standards and regulations, including HIPAA and GDPR. The application is downloaded from Medit Link and integrates with SmileStream services. Both the Medit Link software and SmileStream are hosted by AWS and use AWS Firewall Manager.

Instructions for Use

• User Authentication: Ensure that only authorized users access the Medit Orthodontic Suite app. Use your unique username and password credentials to log in. Contact your system administrator for assistance with account setup or password reset.

• Data Encryption: Medit Orthodontic Suite encrypts sensitive patient data both at rest and in transit. Ensure that you use secure internet connections when accessing the software and follow recommended security protocols.

• Secure Access: Access the Medit Orthodontic Suite app only from trusted devices and Medit Link. Avoid using public Wi-Fi or shared devices for accessing patient data to prevent unauthorized access or interception.

• Incident Reporting: Report any suspicious activities, security incidents, or potential data breaches immediately to your system administrator or IT security team. Follow established incident reporting procedures for prompt investigation and resolution.

• Regular Updates: Keep the Medit Orthodontic Suite app up to date with the latest security patches and updates. Regularly check for software updates and apply them promptly to address known vulnerabilities and enhance cybersecurity defenses. Back up your data regularly and make sure the “restore” function on your hardware is switched on.

• Security Awareness: Stay informed about cybersecurity best practices and threats relevant to orthodontic software. Participate in cybersecurity awareness training sessions and follow recommended guidelines for protecting patient data and maintaining system security.

Security Contact Information

Compliance Statement

The Medit Orthodontic Suite app complies with relevant cybersecurity regulations and standards, including HIPAA, GDPR, and industry best practices. It is designed to safeguard patient data and ensure the highest standards of cybersecurity.

⚠️Disclaimer

While the Medit Orthodontic Suite app employs robust cybersecurity measures, it is essential to follow recommended security practices and remain vigilant against potential threats. The software provider is not liable for damages resulting from user negligence or non-compliance with security instructions.

System Requirements

Hardware Requirements

Software Requirements

Installation Guide

1. Log into your Medit Link account and go to the App Box on the left-hand menu.

2. Find the Medit Orthodontic Suite app and click “Install.“
   

3. The app will be downloaded and installed automatically. It may take several minutes to finish the installation process; do not turn off the PC or close Medit Link.

   ⚠️Warning

   Do not skip the CUDA installation, as it is required to enable the use of cephalometric data and related features. Without it, the functionality of the program will be limited.

4. Once the app is installed, you can run it from any case in Medit Link by clicking the app icon in the top right corner of the Case Detail window.