The Insignia Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient.

Device Description

The Insignia software creates a computer model of the patient's dentition based on either a stone model or impression of the patient's dentition. Insignia operators and the orthodontist use this computer model to determine the placement and/or modification of dental brackets to achieve the intended repositioning of the teeth. Ormco then manufactures foam bracket placement jigs to position the brackets on the patient's teeth in specific positions prescribed by the orthodontist. The orthodontist uses the foam jigs to place and secure the brackets with a commercially-available dental adhesive.

Insignia consists of the following components and accessories:

Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist.
Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets.
Patient-specific foam bracket placement jigs to affix the brackets in position.
Either commercially-available or patient-specific shaped traditional archwires.
The device does not include the adhesive that affixes the brackets to the teeth.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Insignia device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria (e.g., minimum accuracy percentages, error tolerances) for the Insignia software. Instead, it relies on a comparison to a predicate device and a statement of "successful validation."

Acceptance Criteria (Not Explicitly Stated as Numerical Targets)	Reported Device Performance (Summary Statements)
Software Performance (General)	"the Insignia software has been successfully validated to confirm the performance of the device."
Substantial Equivalence to Predicate Device (OrthoCAD iQ)	"Insignia functions in a manner similar to and is intended for the same use as OrthoCAD iQ... Based upon... successful validation of the Insignia software, the performance of Insignia is deemed to be substantially equivalent to OrthoCAD iQ." The detailed comparison table outlines similar technological characteristics, intended use, treatment plan sequence, bracket materials, archwire materials, positioning device materials, mode of use, description of appliance placement, and manufacturing method between Insignia and OrthoCAD iQ.

Acceptance Criteria (Not Explicitly Stated as Numerical Targets)

Reported Device Performance (Summary Statements)

Software Performance (General)

"the Insignia software has been successfully validated to confirm the performance of the device."

Substantial Equivalence to Predicate Device (OrthoCAD iQ)

"Insignia functions in a manner similar to and is intended for the same use as OrthoCAD iQ... Based upon... successful validation of the Insignia software, the performance of Insignia is deemed to be substantially equivalent to OrthoCAD iQ." The detailed comparison table outlines similar technological characteristics, intended use, treatment plan sequence, bracket materials, archwire materials, positioning device materials, mode of use, description of appliance placement, and manufacturing method between Insignia and OrthoCAD iQ.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for any test set used to validate the software. It merely states "the Insignia software has been successfully validated." There is no information provided regarding data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish a ground truth for a test set. The validation information is extremely high-level and lacks details about specific methodologies.

4. Adjudication Method for the Test Set

Since no test set with expert-established ground truth is described, there is no information provided regarding an adjudication method.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The document explicitly states: "Clinical testing has not been conducted on this product." The focus is on software validation and biocompatibility, not on human-in-the-loop performance or comparison to human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A standalone study of the algorithm's performance, separate from human interaction, was done, but with very limited detail. The statement "the Insignia software has been successfully validated to confirm the performance of the device" indicates a standalone evaluation of the software. However, the specifics of this validation (e.g., metrics, methodology, dataset) are not provided in the summary.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the software validation. Given the nature of the device (treatment planning and bracket positioning), the ground truth for an ideal outcome would likely be established through engineering design specifications, simulated clinical scenarios, or potentially comparisons to historical treatment outcomes, but this is not detailed.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. As a software for treatment planning, it's possible that the "training" refers more to the development and refinement of algorithms based on orthodontic principles and mechanical models rather than traditional machine learning training data.

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

The document does not describe how ground truth for a training set was established. This lack of detail is consistent with the generally high-level overview of software validation provided in the summary.

Summary

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510(k) Summary

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Above the logo are the numbers '6121524'. Below the logo, the words 'SYBRON DENTAL SPECIALTIES' are printed in a smaller, sans-serif font.

AUG 9 · 2012

Submitter:

Sybron Dental Specialties, Inc ... 1717 West Collins Avenue Orange, California 92867_ (714) 516-7602 - Phone (714) 516-7488 - Facsimile Wendy Garman - Contact Person

Date Summary Prepared: May 2012

Device Name:

Trade Name Insignia o
Common Name Accessory to Orthodontic Brackets o
Classification Name Orthodontic Plastic Bracket, per 21 CFR § 872.5470 o
Product Codes Orthodontic Plastic Bracket (DYW), Orthodontic Ceramic Bracket . � (NJM) and Orthodontic Metal Bracket (EJF)

Devices for Which Substantial Equivalence is Claimed:

OrthoCAD iQ, Cadent, Inc., K082207 o

Device Description:

Principles of Operation

Ormco Corp. - 510(k) Submission - INSIGNIA

005_510(k) Summary - page 2 of 5 800-537-7824 714-516-7400

1717 West Collins Avenue, Orange, CA 92867

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Technological Characteristics

Insignia consists of the following components and accessories:

1. Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist.
1. Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets.
1. Patient-specific foam bracket placement jigs to affix the brackets in position.
1. Either commercially-available or patient-specific shaped traditional archwires.
The device does not include the adhesive that affixes the brackets to the teeth.

Indications for Use:

Summary of Technological Characteristics:

Insignia is substantially equivalent to another legally marketed device in the United States. Insignia functions in a manner similar to and is intended for the same use as OrthoCAD iQ that is currently marketed by Cadent, Inc.

Features	Insignia	OrthoCad IQ
Intended Use	Insignia is a computer-guided systemintended for use as an aid in orthodontictreatment planning for use by dentalprofessionals trained in orthodontictreatment including radiographic analysesand treatment planning. Insignia isintended for use with commercially-available and/or individually modifiedbrackets and wires that apply continuousgentle force to reposition the teeth. Italso uses patient-specific foam placementjigs to affix the brackets in position.	OrthoCad IQ is a computer-guidedsystem intended for use as an aid inorthodontictreatment planning for use by dentalprofessionals trained in orthodontictreatment including radiographicanalyses and treatment planning.OrthoCad IQ is intended for use withcommercially-available brackets andwires that apply continuous gentleforce to reposition the teeth. It alsouses molded thermoplastic trays toaffix the brackets in position.
Sequence ofTreatment Plan	• A 3D digital model is created based ona stone model or a patient's dentalimpression	• A 3D digital model is created froma patient's impression
Features	Insignia	OrthoCad IQ
	A 3D end-of-treatment outcome model is generated	A 3D end-of-treatment outcome model is generated
	The 3D model is sent to the orthodontist for review	The 3D model is sent to the orthodontist for review
	Foam bracket placement jigs are manufactured to position the brackets on the patient's teeth as prescribed by the orthodontist	Customized trays are created with each bracket in the ideal position to achieve the desired outcome.
	Brackets are adhered to the patient's teeth	Brackets are adhered to the patient's teeth
Bracket Material	Stainless Steel / Ceramic / Plastic	Stainless Steel / Ceramic /Plastic
ArchwireMaterial	Stainless Steel / Nickel Titanium / Beta Titanium	Stainless Steel / Nickel Titanium / Beta Titanium
PositioningDevice Material	Plastic foam	Thermoformed plastic
Mode of Use	Either patient-specific (individually modified) or standard appliances are fixed to the patient's teeth using patient-specific foam placement jigs. Patient-specific archwires of traditional metallurgy are provided. The appliances are fixed to the teeth with commercially available adhesives.	Standard appliances are fixed to the patient's teeth using thermoformed trays. Archwires of traditional metallurgy are selected. The appliances are fixed to the teeth with commercially available adhesives.
Description ofAppliancePlacement	Affixed and removed by clinician	Affixed and removed by clinician
ManufacturingMethod	Final desired arrangement of teeth, brackets, wires and jigs are designed with the guidance of computer software using 3-dimensional models of the patient. In-office software allows the clinician to review, alter and approve desired result and appliances. Software generates code that drives machinery to manufacture the appliances	Final desired arrangement of teeth is designed with the guidance of computer software using 3-dimensional models of the patient. In-office software allows the clinician to select, review, alter and approve desired result and appliances

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Non-Clinical Test Data:

Biocompatibility studies (Cytotoxicity, Irritation and Sensitization) have been completed which demonstrate that the Insignia components including the bracket placement jig, the jig adhesive and the midline marker for the archwire, are safe for their intended use.

Additionally, the Insignia software has been successfully validated to confirm the performance of the device.

Clinical Test Data:

Clinical testing has not been conducted on this product.

Conclusion:

Based upon the biocompatibility studies, similar technological characteristics to the predicate device, and successful validation of the Insignia software, the performance of Insignia is deemed to be substantially equivalent to OrthoCAD iQ.

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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 & Human Services. The logo features a stylized image of an eagle or bird in flight, with its wings spread and head turned to the right. The bird is depicted in a simple, abstract manner using thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird.

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

9 2012 AUG

ORMCO Corporation C/O Sybron Dental Specialties, Incorporated Ms. Wendy Garman Director, Regulatory Affairs 1717 West Collins Avenue Orange, California 92867

Re: K121524

Trade/Device Name: Insignia Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW. NJM. EJF Dated: July 27, 2012 Received: July 30, 2012

Dear Ms. Garman:

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. Garman

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 device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours,

hh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Insignia

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K921524

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.