CEREC Ortho Software is intended for use with image data acquired from handheld intra oral 3D cameras and desktop laboratory scanners to create 3D virtual models to be used for data acquisition and modeling analysis for orthodontic patients and conditions. The CEREC Ortho Software 3D model data can be exported to orthodontic design software to aid in the design of orthodontic appliances.

Device Description

The CEREC Ortho Software is stand-alone software which utilizes images of the patient's intraoral anatomy from intra-oral cameras and/or desktop laboratory scanners to create a 3D virtual dental model that can be used in the same manner as a traditional physical dental model.

The CEREC Ortho Software facilitates the segmentation and editing of the 3D virtual digital model as well as analysis which can be used in secondary orthodontic treatment planning. The software allows for measurement and jaw analysis to be performed - including Bolton, Nance, and Moyers analyses. The models and analysis produced by the proposed CEREC Ortho Software can be exported to an orthodontic laboratory or directly to orthodontic appliance manufacturers for use in orthodontic treatment planning and design of orthodontic appliances.

AI/ML Overview

The document provides information on the CEREC Ortho Software (K171122) and its substantial equivalence to a predicate device. Here's a breakdown based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. However, it states that "Testing to verify the accuracy of the measurement functions of the CEREC Ortho Software as well as the trueness and precision of optical impressions produced using CEREC optical impression systems and the CEREC Omnicam intra-oral scanner (510(k)-exempt under 21 CFR 872.3661)" was conducted. The conclusion is that "the results support substantial equivalence." This implies that the device met internal performance criteria for accuracy, trueness, and precision, which were deemed sufficient for substantial equivalence.

Therefore, the table cannot be fully completed as requested due to the absence of specific numeric acceptance criteria and detailed performance results in the provided text. However, we can infer the tested aspects:

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Accuracy of measurement functions	Verified (Supports substantial equivalence)
Trueness of optical impressions	Verified (Supports substantial equivalence)
Precision of optical impressions	Verified (Supports substantial equivalence)
Conformity with IEC 62304	Achieved (Software validated)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Testing to verify the accuracy of the measurement functions of the CEREC Ortho Software as well as the trueness and precision of optical impressions produced using CEREC optical impression systems and the CEREC Omnicam intra-oral scanner." However, it does not specify the sample size used for these tests, nor the country of origin of the data, or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide any information about experts used to establish ground truth for the test set or their qualifications. The non-clinical performance data section focuses on software verification and accuracy/trueness/precision of impressions, suggesting a more technical assessment rather than expert evaluation of diagnostic outcomes for the test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method for the test set, as it does not detail the process of establishing ground truth by experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the standalone performance of the software in creating and analyzing 3D models. The software aids in orthodontic treatment planning but does not directly assess human reader performance improvements.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment was done. The "Non-Clinical Performance Data" section describes "Testing to verify the accuracy of the measurement functions of the CEREC Ortho Software as well as the trueness and precision of optical impressions produced using CEREC optical impression systems and the CEREC Omnicam intra-oral scanner." This testing evaluates the algorithm's output (measurements, trueness, precision of models) directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The type of "ground truth" implicitly used for the non-clinical performance testing would be physical measurements or established standards for accuracy, trueness, and precision of dental impressions and model measurements. For example, to verify the accuracy of measurement functions, the software's measurements would likely be compared against known, perhaps physically measured, distances or angles on a reference model or object.

8. The sample size for the training set

The document does not explicitly state a sample size for the training set. As this is a 510(k) submission for software that creates 3D virtual models for analysis, rather than a deep learning AI model for image interpretation, the concept of a "training set" in the machine learning sense might not directly apply in the same way. The software likely relies on algorithms and computational geometry for model creation and analysis, which are developed and validated through engineering principles rather than large-scale data training.

9. How the ground truth for the training set was established

Given that a "training set" in the machine learning context is not explicitly mentioned, and the software's function is more about model creation and measurement based on scans, the concept of ground truth for a training set in the typical AI sense is not addressed. The underlying algorithms would be developed and refined based on established principles of dental anatomy, imaging, and metrology.

Summary

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January 11, 2018

Dentsply Sirona Karl J. Nittinger Senior Manager & Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401

Re: K171122

Trade/Device Name: CEREC Ortho Software Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: December 11, 2017 Received: December 13, 2017

Dear Karl J. Nittinger:

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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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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S

For Tina Kiang, Ph.D. Acting 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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Indications for Use

510(k) Number (if known)

K171122

Device Name

CEREC Ortho Software

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5. 510(k) SUMMARY K171122 CEREC Ortho Software

1. Submitter Information:

Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404

Contact Person:	Karl Nittinger
Telephone Number:	717-849-4424
Fax Number:	717-849-4343

Date Prepared: January 5, 2018

2. Device Name:

• Proprietary Name:	CEREC Ortho Software
• Classification Regulation Name:	Orthodontic plastic bracket.
• CFR Number:	21 CFR 872.5470
• Device Class:	Class II

Product Code: PNN (Orthodontic Software) ●

Predicate Device: 3.

The predicate device for the CEREC Ortho Software is:

Predicate Device Name	510(k)	Company Name
3Shape Ortho System™	K152086	3Shape A/S

4. Description of Device:

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The proposed CEREC Ortho Software is intended to be used wherever cast impressions are used and in the identical manner in which the traditional physical models are used (i.e., to record topographical characteristics of dentition, gingiva, palate, and/or oral anatomy in conjunction with the treatment planning and production of orthognathic/orthodontic appliances).

న. Indications for Use:

6. Substantial Equivalence:

The CEREC Ortho Software has the same intended use and incorporates the same fundamental technology as the predicate software device. Both the CEREC Ortho Software and the predicate 3Shape Ortho System™ (K152086) are stand-alone software devices which are intended as Orthodontic Treatment Software devices (Product Code PNN, under 21 CFR 872.5470 ) and. as such are intended to aid in the diagnosis and treatment planning of orthodontic patients and conditions.

Detailed comparison of the intended use and technological characteristics and features of the CEREC Ortho Software and the predicate 3Shape Ortho System™ (K152086) devices is presented in Tables 6.1 and 6.2.

Table 6.1: Indications for Use

Subject DeviceCEREC Ortho Software	Predicate Device3Shape Ortho System™(K152086)
CEREC Ortho Software is intended for use with image dataacquired from handheld intra oral 3D cameras and desktoplaboratory scanners to create 3D virtual models to be used for dataacquisition and modeling analysis for orthodontic patients andconditions. The CEREC Ortho Software 3D model data can beexported to orthodontic design software to aid in the design oforthodontic appliances.	3Shape Ortho System™ is intended for use as amedical front-end device providing tools formanagement of orthodontic models, systematicinspections, detailed analysis, treatment simulationand virtual appliance design options (Custom metalbands, Export of Models, Indirect Bonding TransferMedia) based on 3D models of the patient's dentitionbefore the start of an orthodontic treatment. It can alsobe applied during the treatment to inspect and analyzethe progress of the treatment. It can be used at the endof the treatment to evaluate if the outcome is consistentwith the planned/desired treatment objectives.The use of Ortho System™ requires the user to havethe necessary training and domain knowledge in thepractice of orthodontics, as well as to have receivedtraining in the use of the software.
Proposed DeviceCEREC Ortho Software	Predicate Device3Shape Ortho System™(K152086)
Supported Computer Formats
- Intended for loading on a personal computer.	- Intended for loading on a personal computer.
Minimum requirements:	Minimum requirements:
- Functions within Windows 7, 64-bit operating system.	- Functions within Windows 7 or 8, 64-bit operating system.
- 250 GB hard disk storage.	- 250 GB hard disk storage.
- 8 GB RAM memory.	- 8 GB RAM memory.
- Intel QuadCore 1.6 GHz processor.	- Intel Core i5 or equivalent processor.
- NVidia or AMD graphics card with 1 GB memory.	- GeForce graphics card with 1 GB memory.
Acquisition Data Formats Support
Intra-oral scan data	Intra-oral scan data
Desktop scanner STL data	Desktop scanner STL data
N/A	Computed Tomography (CT) DICOM image data
N/A	2D overlay data
Supported anatomic areas
Maxilla	Maxilla
Mandible	Mandible
Functionality
Acquisition of oral topography image data	Acquisition of oral topography image data
Creation of virtual 3D virtual dental models	Creation of virtual 3D virtual dental models
Alignment of 3D virtual dental models	Alignment of 3D virtual dental models
Measurement of 3D virtual dental models	Measurement of 3D virtual dental models
Analysis of 3D virtual dental models	Analysis of 3D virtual dental models
N/A	Orthodontic treatment simulation
N/A	Virtual orthodontic appliance design
Exporting of 3D virtual model and analysis data	Exporting of 3D virtual model, analysis and treatment casedata
Proposed DeviceCEREC Ortho Software	Predicate Device3Shape Ortho System™(K152086)
Analysis Features
Occlusal mapping	Occlusal mapping
Tooth and gingiva separation/segmentation	Tooth and gingiva separation/segmentation
Definition of dental arch shape and length	Definition of dental arch shape and length
Tooth width measurements	Tooth width measurements
Bolton's analysis	Bolton's analysis
Nance and Moyer space analyses	Space analyses
Orthodontic Treatment Simulation
N/A	2D and 3D simulated orthodontic treatment
Virtual Orthodontic Appliance Design
N/A	Orthodontic appliance search library.
N/A	Virtual placement of orthodontic appliances.
N/A	Design of orthodontic appliances
N/A	Export of orthodontic appliance designs

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Table 6.2: Technological Characteristics and Features

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Table 6.2: Technological Characteristics and Features (continued)

The CEREC Ortho Software and the predicate 3Shape Ortho System™ (K152086) both facilitate their intended use through the acquisition of image scan data of the oral topography. With the acquired image data, the proposed device and predicate device (K152086) create 3D virtual dental models of the patient's dentition. These virtual dental models are functional equivalents of physical cast models.

The CEREC Ortho Software and the predicate 3Shape Ortho System™ (K152086) automatically provide alignment tools, measurement, and perform analysis of the 3D virtual models. With respect to the proposed CEREC Ortho Software, the 3D virtual model and finalized analysis can be exported to support orthodontic treatment planning. However, in the case of the predicate 3Shape Ortho System™ (K152086), orthodontic treatment planning is also integral to the software device functionality through: simulated orthodontic treatment; virtual design and placement of orthodontic appliances, and export for the finalized orthodontic treatment plan.

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7. Non-Clinical Performance Data

In support of the substantial equivalence of the CEREC Ortho Software, performance and software testing were conducted and are included and the results support substantial equivalence:

. Testing to verify the accuracy of the measurement functions of the CEREC Ortho Software as well as the trueness and precision of optical impressions produced using CEREC optical impression systems and the CEREC Omnicam intra-oral scanner (510(k)-exempt under 21 CFR 872.3661).
Validation of the CEREC Ortho Software in conformity with IEC 62304 (Medical device . software – Software lifecycle processes).

The CEREC Ortho Software does not include any physical device, accessory, or component with patient contacting intended use. Therefore, no biocompatibility data, sterilization, or shelf life analyses were included in support of substantial equivalence.

8. Clinical Performance Data

No human clinical data was included to support substantial equivalence.

9. Conclusion Regarding Substantial Equivalence

The CEREC Ortho Software has the same intended use as that of the predicate 3Shape Ortho System™ (K152086) software. Both devices are orthodontic software devices regulated under 21 CFR 872.5470 and as such are intended for use to aid in the diagnosis and treatment planning of orthodontic patients and conditions.

The predicate 3Shape Ortho System™ (K152086) is additionally regulated as a Radiological Image Processing System under 21 CFR 892.2050 due to its functionality to utilize CT DICOM images as input. However, the proposed CEREC Ortho Software does not incorporate this functionality and therefore is proposed for an intended use which is a subset of the predicate device (K152086) to which it is compared.

Non-clinical testing and software validation data are included to demonstrate the performance of the CEREC Ortho Software against its design, functional, and safety requirements. The results of the testing support a determination of substantial equivalence.

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.