MTM® Clear Aligner In-Office is indicated for the treatment of anterior tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental minor tooth movements (torque, tipping, rotation and bodily movement), MTM® Clear Aligner sequentially positions teeth by way of continuous gentle force.

Device Description

MTM® Clear Aligner In-Office is a system of plastic aligners fabricated in the dental professional's office that are modified with thermoplier accessories to create force points and spaces necessary for tooth movement by way of continuous gentle force. Commercially available auxiliaries such as hooks and orthodontic elastics may also be used in order to create the desired tooth movement. As the aligner is positioned on any particular tooth, the presence of the force points loads the polymeric shell material. The stored energy thus imparted into the elastomeric material of the aligner slowly dissipates over time as the bone underlying the tooth physiologically responds to the forces. After each desired incremental tooth movement has occurred, the aligner can be modified to increase the size of the force points or a new aligner may be fabricated. Each aligner moves the patient's teeth in small increments from their original state.

AI/ML Overview

This document describes the acceptance criteria and the study conducted to prove that the MTM® Clear Aligner In-Office device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MTM® Clear Aligner In-Office were based on its ability to achieve incremental minor tooth movements, as stated in its Indications for Use. The clinical study aimed to demonstrate this capability.

Acceptance Criteria (Ability to achieve)	Reported Device Performance (Number of cases successfully treated)
Incremental minor tooth movement: Torque	5 cases
Incremental minor tooth movement: Tipping	7 cases
Incremental minor tooth movement: Rotation	14 cases
Incremental minor tooth movement: Bodily Movement	11 cases
Safety (No adverse events, including root resorption)	No adverse events reported

2. Sample Size and Data Provenance for the Test Set

Sample Size: The document lists the number of cases successfully treated for each type of tooth movement: 5 for Torque, 7 for Tipping, 14 for Rotation, and 11 for Bodily Movement. The total number of unique patients or overall cases included in the study is not explicitly stated but is implicitly the sum of cases across all movement types if each case represented a unique patient with a primary movement type, or possibly a smaller number if a single patient experienced multiple types of movements. Without further detail, it's difficult to ascertain the exact total number of individuals.
Data Provenance: The study was a "prospective open-label safety and effectiveness study." The country of origin for the data is not specified.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Number of Experts: The document does not specify the number of experts explicitly. However, it mentions that the study included a "pretreatment period for establishing baseline root integrity and tooth position and to develop a treatment plan." This implies that dental professionals (likely orthodontists or dentists) were involved in assessing the initial state and planning the treatment for each patient.
Qualifications of Experts: The specific qualifications of these experts are not detailed, but it can be inferred that they were dental practitioners responsible for treatment planning and monitoring.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing the ground truth or evaluating the outcomes of the test set. The study design focused on documenting "progression of the case" and establishing "final tooth position and root integrity," which suggests that the clinical outcomes were assessed directly by the participating practitioners as part of the prospective study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study focused on the performance of the device itself rather than comparing human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only)

This device is an in-office system of physical aligners and accessories, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The device inherently requires human intervention (dental professional's fabrication, modification, and patient's wear).

7. Type of Ground Truth Used

The ground truth used was based on clinical outcomes assessed by dental professionals. This included:

Pre-treatment establishment of "baseline root integrity and tooth position."
Documentation of "progression of the case" during treatment.
Post-treatment establishment of "final tooth position and root integrity" to determine the "magnitude of total tooth movement."
Monitoring for "adverse events, including root resorption."

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. The MTM® Clear Aligner In-Office system is a physical medical device, not a software algorithm that requires a training dataset.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable.

Summary

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K123925

SECTION 5: 510(k) SUMMARY

MAY 2 4 2013

510(k) SUMMARY for MTM® Clear Aligner In-Office

1. Submitter Information:

DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

Contact Person:	Helen Lewis
Telephone Number:	717-849-4229
Fax Number:	717-849-4343

Date Prepared: May 7, 2103

2. Device Name:

Proprietary Name: MTM® Clear Aligner In-Office ●
Classification Name:

Aligner, Sequential

CFR Number: 872.5470
Device Class:
- II Product Code: NXC

3. Predicate Device:

Product Name	510(K)	Company Name
Invisalign® System	K081960	Align Technology, Inc.

4. Description of Device:

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5. Indications for Use:

6. Description of Safety and Substantial Equivalence:

Technological Characteristics:

The MTM® Clear Aligners that are created in-office have the same technological characteristics as the predicate device, in that all the devices are made from commercially available plastic that is thermoformed to create a customized, patient-specific aligner. The aligners are then used for minor tooth movement by way of continuous gentle force.

In both systems, the aligners are created by thermoforming commercially available plastic material. The MTM® Clear Aligners are thermoformed by the healthcare practitioner in-office and in the case of the predicate device; the aligners are thermoformed by an outside laboratory. The plastic used for MTM Clear Aligners is cleared under K062828, Mouthguard and Aligner Material.

The MTM® Clear Aligner In-Office system incorporates the use of thermobiler accessories to create spaces and force points in order to cause minor tooth movement, These force points are located in specific areas and positioned in such a way that they provide a continuous force which slowly dissipates over time on the tooth to be moved for as long as the aligner is worn. The predicate device system also has the option of creating force points using pliers ("plier detailing") as a supplemental treatment to facilitate minor tooth movement.

With the MTM® Clear Aligner In-Office system, auxiliaries such as hooks, buttons, and orthodontic elastics may be used by the healthcare practitioner together with the aligner for the purpose of tooth movement. The H.I.T.® - Hook Inserting Tack System, is designed to insert external hooks onto the MTM® Clear Aligners for the purposes of attaching elastics. The H.I.T.® system consists of a H.I.T.® punch plier (used to punch a hole into the aligner into which the hook is inserted), a H.I.T.® insertion plier (used to insert the hook into the MTM® Clear Aligners), and the H.I.T.® hooks (a hook used to attach the elastics). Commercially available orthodontic elastics can be used to attach to the hooks. These auxiliaries are attached to the aligner and not the teeth, and the usage of these auxiliaries is determined by the dental practitioner. With the predicate system, the healthcare practitioner also has the option of using these types of auxiliary components in-office with the aligner for the purpose of tooth movement.

In both systems, the aligners can be removed by the patient at any time, and treatment can be discontinued at any time.

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Non-Clinical Performance Data:

The MTM® Clear Aligner In-Office System is composed of existing, commercially available DENTSPLY Mouthguard and Aligner Materials which are cleared in premarket notification K062828. Material properties data derived from the methods described in ISO 20795-2 (Dentistry - Base polymers - Part 2: Orthodontic base polymers), ASTM D790 (Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials), ASTM D570 (Standard Test Method for Water Absorption of Plastics), and ASTM D256 (Standard Test Method for Determining the Izod Pendulum Impact Resistance of Plastics) for the aligner materials have been included to support substantial equivalence. No additional in vitro testing of finished, customized aligners has been included to support substantial equivalence. Clinical data is included to validate that the MTM® Clear Aligner meets the requirements of its intended use.

Clinical Performance Data

A clinical study was performed in order to support the safety and efficacy of the MTM® Clear Aligner In-Office System. The objective of the study was to demonstrate the ability of the MTM® Clear Aligner In-Office to achieve incremental minor tooth movement (including torque, tipping, rotation and bodily movement), using a series of aligners consistent with and fully supportive of the product's indications for use.

The three phase prospective open-label safety and effectiveness study included a pretreatment period for establishing baseline root integrity and tooth position and to develop a treatment plan, an in-treatment monitoring period to document progression of the case, and a post-treatment period designed to establish final tooth position and root integrity. This data was also used to determine the magnitude of total tooth movement.

The study results included the following number of teeth successfully treated by sequential aligners:

• Torque	5 cases
• Tipping	7 cases
• Rotation	14 cases
• Bodily Movement	11 cases

No adverse events, including root resportion, were reported during the study.

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Conclusion Regarding Substantial Equivalence:

MTM® Clear Aligner In-Office moves teeth by way of continuous gentle force through a sequence of clear aligners that follow the treatment plan developed by the clinician as does the predicate, Align System.

MTM® Clear Aligner In-Office is substantially equivalent to the predicate Invisalign System originally cleared under premarket notification K981095 and subsequently modified under premarket notification K081960. The MTM® Clear Aligner In-Office incorporates the same fundamental technology, is composed of similar materials, has the same intended use, and similar indications for use. Clinical data has been further provided to support the safety and efficacy of the MTM® Clear Aligner system when used within its proposed intended use. The conclusion of the design and intended use comparison of the MTM® Clear Aligner In-Office to the predicate device and the results of the clinical data included in this premarket notification support substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 24, 2013

Ms. Helen Lewis Director Corporate Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street YORK PA 17405

Re: K123925

Trade/Device Name: MTM® Clear Aligner In-Office Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: April 30, 2013 Received: May 2, 2013

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Susan Runner, DDS,BA

Digitally signed by Mary S. Runner -5
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
cn=Mary S. Runner -S.
0.9.2342.19200300.100.1.1=130008795

Date: 2013.05.24 14:33:43-04'00'

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4: INDICATIONS FOR USE STATEMENT

1123925 510(k) Number (if known):

Device Name: MTM® Clear Aligner In-Office

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner, DDS, MA

(Division Sign-Off)

Digitally signed by Mary S. Runner -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Mary S. Runner

0.9.2342.19200300.100.1.1=1300087950
Date: 2013.05.10 08:33-22 04:00

Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number: K123925

MTM Clear Aligner In-Office

Regulation Number and Section

§ 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.