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

Device Description

The Insignia software creates a computer model of the patient's dentition based on a stone model, iTero scan file or impression of the patient's dentition. The iTero scanner produces a digital scan of a patient's tooth data as an alternative to the physical dental impressions. 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 with iTero 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. 2) Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets. 3) Patient-specific foam bracket placement jigs to affix the brackets in position. 4) 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

The provided text describes the "Insignia with iTero" device, an orthodontic treatment planning software and appliance system. It claims substantial equivalence to two predicate devices: "Insignia (K121524)" and "Biomet 3i Using Cadent iTero Scanner (K102209)".

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a typical pass/fail format with specific thresholds. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The primary performance aspect highlighted is the accuracy of the digital impression file generated from the iTero scanner.

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy of digital impression file must be verified.	Accuracy testing of the digital impression file generated from the iTero scanner has been successfully verified.
Functionality and intended use must be similar to predicate devices.	"Insignia with iTero functions in a manner similar to and is intended for the same use as Insignia that is currently marketed by Ormco." "The iTero scanner used with Insignia is the same device that is used by Biomet 3i..."

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

Sample Size: Not specified. The document only mentions "Accuracy testing of the digital impression file..." without providing the number of scans or measurements included in this testing.
Data Provenance: Not specified. It's unclear if the testing was retrospective or prospective, or the country of origin of the data.

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

Not specified. The document simply mentions "Accuracy testing" without detailing how the ground truth for this testing was established or if experts were involved in its determination.

4. Adjudication Method for the Test Set:

Not specified. There's no mention of any adjudication method (e.g., 2+1, 3+1, none) for the accuracy testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The device is not presented as an AI-assisted diagnostic tool for human readers but rather as a treatment planning software and appliance system. The evaluation focused on the accuracy of the digital impression and substantial equivalence to existing devices, not on human reader improvement with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, implicitly. The "Accuracy testing of the digital impression file generated from the iTero scanner" appears to be a standalone performance evaluation of the scanner component, which produces a digital output (algorithm only) as an alternative to physical impressions. The software then uses this digital model for treatment planning. The "Insignia software" itself also operates in a standalone manner to calculate bracket positions.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

Not explicitly defined. For the "accuracy testing of the digital impression file," the ground truth likely involved a comparison against a highly accurate reference measurement of the dentition. This could be a physical impression measured with high-precision instruments or a different, highly accurate 3D scanning method considered the gold standard. However, the document does not specify the exact nature of this ground truth.

8. The Sample Size for the Training Set:

Not applicable/not specified. The document describes a "proprietary software that calculates the position of dental brackets" and the "iTero scanner" which produces digital scans. While these systems likely have internal algorithms that were developed and potentially "trained," the document does not discuss a training set in the context of machine learning or AI models in the modern sense. The focus is on the output accuracy of the system's components.

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

Not applicable/not specified. As with the training set itself, the document does not provide details on how ground truth would have been established for any internal training or development of the software or scanner's algorithms.

Summary

{0}------------------------------------------------

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. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The logo is black and white.

MAR 1 3 2013

510(k) Summary

Submitter:

Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person

March 2013 Date Summary Prepared:

Device Name:

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

Devices for Which Substantial Equivalence is Claimed:

. Insignia, Ormco Corporation, K121524
Biomet 31 Patient Specific Dental Abutments (Encode) Designed Using Cadent iTero Scanner . and inLab Software Version v.3.5, K102209

Device Description:

{1}------------------------------------------------

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 with iTero 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.

Indications for Use:

The Insignia Orthodontic System is compatible with the iTero scanner.

Summary of Technological Characteristics:

Insignia with iTero is substantially equivalent to two other legally marketed devices in the United States. Insignia with iTero functions in a manner similar to and is intended for the same use as Insignia that is currently marketed by Ormco. Additionally, the iTero scanner used with Insignia is the same device that is used by Biomet 3i to manufacture the patient-specific dental abutments as described in below.

Features	Insignia With iTero	Insignia (K121524)	Biomet 3i UsingCadent iTeroScanner(K102209)
Indications forUse	Insignia with iTero is atreatment planningsoftware and orthodonticappliance system used tocorrect malocclusions inorthodontic patients,using appliancesindividualized for theorthodontic patient.	The Insignia OrthodonticSystem is a treatmentplanning software andorthodontic appliancesystem used to correctmalocclusions inorthodontic patients,using appliancesindividualized for theorthodontic patient.	Biomet 3i UsingCadent iTero Scanneris intended for use asan accessory toendosseous dentalimplants to support aprosthetic device in apartially or edentulouspatient. These areintended for use to
Features	Insignia With iTero	Insignia (K121524)	Biomet 3i UsingCadent iTeroScanner(K102209)
	The Insignia OrthodonticSystem is compatible withthe iTero scanner.		support single andmultiple toothprostheses, in themandible or maxilla.The prostheses can bescrew or cementretained to theabutment.
Sequence ofTreatmentPlan	A 3D digital model iscreated based on astone model or apatient's dentalimpression or analternate digitalimpression filegenerated from theiTero scanner iscreated andforwarded to Ormco. A 3D end-of-treatment outcomemodel is generated The 3D model is sentto the orthodontist forreview Foam bracketplacement jigs aremanufactured toposition the bracketson the patient's teethas prescribed by theorthodontist Brackets are adheredto the patient's teeth	A 3D digital model iscreated based on astone model or apatient's dentalimpression A 3D end-of-treatment outcomemodel is generated The 3D model is sentto the orthodontistfor review Foam bracketplacement jigs aremanufactured toposition the bracketson the patient's teethas prescribed by theorthodontist Brackets are adheredto the patient's teeth	A digitalimpression filegenerated fromthe iTero scanneris created. The digital file iselectronically sentto Biomet 3i todesign and mill thefinal abutment.
Features	Insignia With iTero	Insignia (K121524)	Biomet 3i UsingCadent iTeroScanner(K102209)
ManufacturingMethod	Final desired arrangementof teeth, brackets, wiresand jigs are designed withthe guidance of computersoftware using 3-dimensional models ofthe patient. In-officesoftware allows theclinician to review, alterand approve desiredresult and appliances.Software generates codethat drives machinery tomanufacture theappliances.	Final desiredarrangement of teeth,brackets, wires and jigsare designed with theguidance of computersoftware using 3-dimensional models ofthe patient. In-officesoftware allows theclinician to review, alterand approve desiredresult and appliances.Software generates codethat drives machinery tomanufacture theappliances.	Not applicable.

{2}------------------------------------------------

{3}------------------------------------------------

Non-Clinical Test Data:

Accuracy testing of the digital impression file generated from the iTero scanner has been successfully verified to confirm the performance of the device.

Clinical Test Data:

Clinical testing has not been conducted on this product.

Conclusion:

Based upon the accuracy testing to the predicate device, Insignia, the performance of Insignia with iTero is deemed to be substantially equivalent.

{4}------------------------------------------------

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 consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

March 13, 2013

Ormco Corporation C/O Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties 1717 West Collins Avenue ORANGE CA 92867

Re: K123416

Trade/Device Name: Insignia with iTero Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW, NJM, EJF Dated: January 28, 2013 Received: January 31, 2013

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.

{5}------------------------------------------------

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.

Image /page/5/Picture/6 description: The image shows the name "Kwame O. Ulmer" superimposed over a stylized FDA logo. The name is written in a bold, sans-serif font, making it easily readable. The FDA logo is rendered in a line art style, with multiple parallel lines creating a three-dimensional effect.

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

{6}------------------------------------------------

Indications for Use

kl23416 510(k) Number (if known):

Device Name: Insignia with iTero

Indications For Use:

The Insignia Orthodontic System is compatible with the iTero scanner.

Prescription Use × {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)

lary S. Runner -S ·47 -04'00'

hesiology, General Hospital Infection Control, Den

510(k) Number:

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.