iTero software is used with the iTero scanner in capturing 3D digital impressions of teeth, oral soft tissue and structures, and bite relationship. iTero software controls the processing of the data, facilitating the integration of data, and exporting of the data for CAD/CAM fabrication of dental restorations, orthodontic devices, abutments, and accessories. In addition to scan data, various patient and case information can be imported/exported or used for simulation purposes. Other functions are available for verification and service of the system and to serve as an order management tool.

Device Description

The iTero software is used with the iTero scanner in capturing 3D digital impressions of teeth, oral soft tissue and structures, and bite relationship. The software supports dental professionals in acquiring very accurate digital images which can be edited and used for planning and simulation. The software controls the export of the data by a secured internet connection for CAD/CAM fabrication of dental restorations, orthodontic devices, abutments, and accessories.

AI/ML Overview

This document refers to the iTero Software and details its 510(k) submission.

Here's an analysis of the acceptance criteria and the study data it provides:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Results of verification/validation testing demonstrate that iTero Software showed conformity with pre-established specifications and acceptance criteria. The acceptance criteria were established in order to demonstrate that iTero Software is safe and effective for its intended use."

However, the specific "pre-established specifications and acceptance criteria" themselves are not detailed in this provided text. Nor are specific numerical performance metrics from the device's testing reported in a table format. The text only offers a general statement of conformity.

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

This information is not provided in the given text.

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not described or referenced in the provided text. The submission focuses on the software's functionality and equivalence rather than an AI-assisted human reader improvement study.

6. Standalone Performance Study

The document indicates that "Results of verification/validation testing demonstrate that iTero Software showed conformity with pre-established specifications and acceptance criteria." This implies a standalone evaluation of the software's performance against its technical and functional specifications. While not explicitly using the term "standalone study," the focus on its own performance against internal criteria suggests a standalone assessment. However, specific metrics of this standalone performance are not provided.

7. Type of Ground Truth Used

The type of ground truth used for verification/validation testing is not explicitly stated. Since the device captures 3D digital impressions, the ground truth would likely involve comparisons to physical models, highly accurate traditional impressions, or possibly other high-precision 3D scanning technologies, but this is an inference based on the device's function, not explicit in the text.

8. Sample Size for the Training Set

This information is not provided in the given text. The iTero Software is described as controlling the processing, integration, and export of scan data, and also for planning and simulation. It's not explicitly presented as an AI/Machine Learning device that undergoes a "training" phase in the conventional sense, as might be the case for image recognition or diagnostic algorithms. Instead, it seems to be a software tool for data acquisition, processing, and management.

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

As the document does not describe a "training set" in the context of an AI/ML algorithm, this information is not applicable/provided. The software's capabilities are more in line with data processing and visualization rather than learning from a dataset to perform a task.

Summary

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SECTION 5: 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: July 26, 2013

510(k) number: K131101

Applicant Information:

Cadent, Ltd. An Align Technology Company 2560 Orchard Parkway San Jose, CA 95131

AUG 2 6 2013

Contact Person

Manas M Lele Regulatory Affairs Analyst Alian Technology, Inc. Phone: (408) 789-1550 Fax: (408) 470-1011 Email: miele@aligntech.com

Device Information:

Trade Name: Classification: Classification Name: iTero Software 21 CFR 872.3630 Abutment, Implant, Dental, Endosseous

Description:

Intended Use:

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Equivalent Device:

iTero Software is substantially equivalent in intended use and/or method of operation to the following devices:

Name	Manufacturer	510(k) #
3M Lava Software	Brontes Technologies, Inc./3M	K062493
Straumann Visual Software	Institut Straumann, AG	K093113

Summary of Technical Characteristics:

Characteristic	Cadent iTero Software	3M Lava Software	Straumann Software
Intended use statement	iTero software is usedwith the iTero scannerin capturing 3D digitalimpressions of teeth,oral soft tissue andstructures, and biterelationship. Thesoftware controls theprocessing of the data,facilitating theintegration of data, andexporting of the data forCAD/CAM fabrication ofdental restorations,orthodontic devices,abutments, andaccessories. In additionto scan data, variouspatient and caseinformation can beimported/exported orused for simulationpurposes. Otherfunctions are availablefor verification andservice of the systemand to serve as an ordermanagement tool.	The Lava software isused with the Lavascanner, an all-ceramicsystem for theCAD/CAM fabrication ofdental restorations,abutments, orthodonticdevices, andaccessories. Thesoftware controls themeasuring process,processing of themeasurement data (3D-CAD tool), and export ofthe data to the millingmachine. In addition,various patient and caseinformation elementscan be entered. Otherfunctions are availablefor verification andservice of themeasuring system. TheLava software alsofacilitates the transfer of3D data from a scannerto a remote millingmachine via internet.	Straumannetkon visual is asoftware deviceintended to importpatient-specific datafrom a scanner forCAD (computer aideddesign) design ofindividual dentalrestorations likecrowns, bridges,inlays, onlays,veneers, andabutments. The visualsoftware alsofacilitates the transferof 3D data from adental lab to a remotemilling center byinternet connectionand serves as anorder managementtool.
Operating System	Windows	Linux	Windows
Programming Language	C++ and C#	C++	C++ and Java
Import/Export DataFormat	STL	STL	STL
Data Visualization	2D and 3D	2D and 3D	3D

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Characteristic	Cadent iTero Software	3M Lava Software	Straumann Software
Principles of Operation:
· Entering andReviewing PatientData	Yes	Yes	Yes
· Scanning	Yes	Yes	Yes●
· Data Review and	Yes	Yes	Yes
Editing
· Data Transfer	Yes	Yes	Yes
		●
· System Operation and	Yes	Yes	Yes
Process Management	�	�
· Abutment Design and	No	No	Yes
Manufacturing

Test Results:

Results of verification/validation testing demonstrate that iTero Software showed conformity with pre-established specifications and acceptance criteria. The acceptance criteria were established in order to demonstrate that iTero Software is safe and effective for its intended use.

Conclusion:

Based on the intended use, product, performance, and software information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices identified.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font.

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

August 26, 2013

Cadent, Limited An Align Technology Company C/O Mr. Manas M. Lele Regulatory Affairs Analyst 2560 Orchard Parkway San Jose, California 95131

Re: K131101

Trade/Device Name: iTero Software Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Il Product Code: NHA, NOF Dated: July 26, 2013 Received: July 29, 2013

Dear Mr. Lele:

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 - Mr. Lele

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industrv/default.htm.

Sincerely vours.

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division 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

510(k) Number (if known): K131101

Device Name: iTero Software

Indications for Use:

Prescription Use × (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Sheena A. Green 2013.08.26 11:31:23 =04'00'

for M. Susan Runner, DDS, MA

(Division Sign-Off) Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices 510 (k) Number: K131101

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)