The NobelDesign Software uses patient-specific data from scanners and defines the shapes of dental prosthetic devices such as dental abutments, copings, crowns and bridges through the use of a CAD tool. The software also serves as a means of creating, ordering and managing cases.

The software is intended to be used at a dental clinic or a dental laboratory. The software uses patient-specific data, e.g., a scanned geometry, and facilitates the CAD of an individual restorative solution based on these data, e.g., a supporting dental framework. The design data of the individualized design and any associated standardized components are transmitted via a network to a production facility where the individualized prosthetic device is manufactured.

Device Description

NobelDesign software is an integrated CAD Software in a cockpit application that enables the user to scan, design and order the designed products (prosthetics).

The software is a solution that allows the use of the NobelProcera 2G scanner and integrates a third party software which is used to perform the actual design (CAD design) for the previously cleared Nobel Biocare patient specific dental implant abutments and implant bridges.

Using this system it is possible for the user to create and track cases, scan models and order NobelProcera prosthetics from the global production resources of Nobel Biocare. NobelDesign v1.0 includes to the following modules:

Design Setup. Module to allow users to define restoration type and design on which tooth position
Scan Center. Module to assist in acquiring all required scans for the design . setup.
Case Management. Module with tools to help manage designs.
Basic Application. Basic functionality (About, Help framework) are in place.
Order Manager. Module for ordering designed components and order tracking.
CAD Design. Module to allows designing of different types of restorations . virtually with easy to use tools.

Each physical product (prosthetic) which is designed in the software has been previously FDA cleared with its own specifications and requirements.

AI/ML Overview

The provided document is a 510(k) premarket notification for the NobelDesign Software, a CAD tool for designing dental prosthetic devices. The document clarifies that this is a new device and seeks substantial equivalence to a predicate device (Procera Software, K053602).

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of numerical acceptance criteria or quantitative performance metrics in the way one might expect for a diagnostic or therapeutic device. Instead, the acceptance criteria are implicitly defined by the successful completion of verification and validation testing to demonstrate that the software meets its design requirements and is substantially equivalent to the predicate device.

The "reported device performance" is described qualitatively as:

Ability to define shapes of dental prosthetic devices: The software uses patient data from scanners to define shapes of dental abutments, copings, crowns, and bridges via a CAD tool.
Case management: It creates, orders, and manages cases.
Integration and functionality: It integrates scanning, design (CAD), and ordering modules effectively.
Adherence to standards: It conforms to Quality System Regulation (21 CFR § 820), ISO 13485, and IEC 62304 (2006).

The focus of this 510(k) is on the functional equivalence and safety in the context of a CAD software, rather than quantifiable clinical performance metrics. The clearance explicitly states that "The final abutment design and all other screw retained restorations (e.g., abutments, crowns and bridges) will continue to be sent to a Nobel Biocare facility for validation of the design for appropriate dimensions and manufacturing." This implies that the software's primary role is to create a design file, and the ultimate "performance" in terms of fit and function is validated downstream by the manufacturer.

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

The document mentions "an entire end-to-end validation (scan, design, and order) for multiple worst-case scenario scan and design requirements." However, it does not specify the exact sample size (e.g., number of cases, number of scan datasets, number of designs).

The data provenance is not explicitly stated in terms of country of origin. The test data are described as "worst-case scenario scan and design requirements," so it's likely synthetic or carefully selected real-world data designed to challenge the software's capabilities. It's not specified whether the data were retrospective or prospective, but for software validation, it often involves pre-existing or engineered datasets.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. Given that the software designs dental prosthetics, "ground truth" would likely involve adherence to dental anatomical principles, manufacturing specifications, and clinical best practices for prosthetic design. This would typically be assessed by experienced dental professionals or engineers specializing in dental prosthetics.

4. Adjudication Method for the Test Set:

The document does not explicitly state an adjudication method. For software validation, ground truth is often established by comparing the software's output against predefined engineering specifications, expert-reviewed designs, or reference physical models. The statement "The final abutment design... will continue to be sent to a Nobel Biocare facility for validation of the design for appropriate dimensions and manufacturing" suggests an internal validation process at the manufacturing facility for the final product, which would involve expert review.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document describes a software validation process focusing on functionality, safety, and substantial equivalence to a predicate device, not a comparative study of human reader performance with and without AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone validation of the algorithm (software) was primarily done. The testing described is focused on the software's ability to fulfill its design requirements: "The performance of the NobelDesign software was verified and validated following the guidance provided in FDA Guidance General Principles of Software Validation... This documentation includes testing which demonstrates that the requirements for the features have been met." This implies evaluating the software's functions (scanning, designing, ordering modules) in isolation to ensure they work as intended. While humans use the software, the validation focuses on the software's correct execution of its programmed functions. The "human-in-the-loop" aspect exists in the sense that a human operator is using the CAD tool, but the validation is of the tool itself.

7. The Type of Ground Truth Used:

The ground truth used for the software validation is based on engineering specifications and functional requirements. The phrase "testing which demonstrates that the requirements for the features have been met" indicates that the software's output (e.g., the generated prosthetic design files) was compared against predetermined specifications for accuracy, completeness, and adherence to design principles. Given the context of dental prosthetic design, this would implicitly involve principles derived from dental anatomy, biomechanics, and manufacturing constraints.

8. The Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. The NobelDesign Software is described as a CAD tool. CAD software typically relies on algorithms based on geometric principles and design rules, rather than machine learning models that require a "training set" of data in the same way an AI diagnostic algorithm would. If any machine learning components were embedded, their training data is not mentioned.

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

Since there's no mention of a traditional "training set" for a machine learning model, this question is not directly applicable. For CAD software, the "ground truth" for its underlying rules and capabilities is established by engineering and dental design principles coded into the software by developers and subject matter experts.

Summary

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

June 2, 2016

Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare, USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887

Re: K153036

Trade/Device Name: NobelDesign Software Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 21, 2016 Received: April 22, 2016

Dear Charlemagne Chua:

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. 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

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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 (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 Industry and Consumer Education at its toll-free 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" (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.

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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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CEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K153036

Device Name NobelDesign Software

Indications for Use (Describe)

The NobelDesign Software uses patients data from scanners and defines the shapes of dental prosthetic devices such as dental abutinents, copings and bridges through the use of a CAD tool. The software also serves as a means of creating, ordering and managing cases

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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A.4 510(k) Summary

Submitter:	Nobel Biocare AB
Address:	Vastra Hamngatan 1Goteborg, SWEDEN 411 17
Establishment Registration No.	9611992
Submitted By:	Nobel Biocare, USA LLC22715 Savi Ranch ParkwayYorba Linda, CA. 92887
Establishment Registration No.	2027971
Contact Person:	Charlemagne ChuaSenior Regulatory Affairs ManagerTelephone: (714) 282-4800
Date Prepared:	June 2, 2016
Classification and Device Name
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	NHA (21 CFR 872.3630)
Trade/Propriety Name:	Nobel Design Software

1. Predicate Device(s):

510(K) Number	Product Name	Manufacturer	Clearance Date
K053602	Procera Software	Nobel Biocare	Feb 10, 2006

2. Reason for Submission:

New Device

3. Device Description:

NobelDesign software is an integrated CAD Software in a cockpit application that enables the user to scan, design and order the designed products (prosthetics).

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. Design Setup. Module to allow users to define restoration type and design on which tooth position
Scan Center. Module to assist in acquiring all required scans for the design . setup.
Case Management. Module with tools to help manage designs. ●
Basic Application. Basic functionality (About, Help framework) are in place. ●
Order Manager. Module for ordering designed components and order tracking. ●
CAD Design. Module to allows designing of different types of restorations . virtually with easy to use tools.

Each physical product (prosthetic) which is designed in the software has been previously FDA cleared with its own specifications and requirements.

4. Indications for Use:

The NobelDesign Software uses patient-specific data from scanners and defines the shapes of dental prosthetic devices such as dental abutments, copings and bridges through the use of a CAD tool. The software also serves as a means of creating, ordering and managing cases.

Criteria	NobelDesign Software(Subject Device)	Procera Software(K053602)Predicate Device	Notes
Indicationsfor Use	The NobelDesign Softwareuses patient-specific datafrom scanners and definesthe shapes of dentalprosthetic devices such asdental abutments, copings,crowns and bridges throughthe use of a CAD tool. Thesoftware also serves as ameans of creating, orderingand managing cases.	Nobel Biocare's ProceraSoftware imports patientspecific data fromscanners and defines theshapes of dental prostheticdevices such as dentalabutments, copings,laminates and bridgesthrough the use of a 3D-CAD tool. The softwarealso serves as means ofordering and managingorders of Procera products	Slight differencewith the additionof crowns andremoval oflaminate. Theaddition ofcrowns to bridgedesign does notchange theintended use ofthe device
Intendeduse	The software is intended tobe used at a dental clinic ora dental laboratory. Thesoftware uses patient-specific data, e.g., ascanned geometry, and	The Procera Software isintended to be used at thelab/clinic to import patientspecific data (eg a scannedgeometry of a tooth) anddesign a patient specific	Same
Criteria	NobelDesign Software(Subject Device)	Procera Software(K053602)Predicate Device	Notes
facilitates the CAD of anindividual restorativesolution based on thesedata, e.g., a supportingdental framework. Thedesign data of theindividualized design andany associatedstandardized componentsare transmitted via anetwork to a productionfacility where theindividualized prostheticdevice is manufactured.	restorative solution basedon these data (eg a dentalprosthetic framework or acoping). The CAD designedsolution is sent via internetto the Procera Productionfacility.
Anatomicareas	MaxillaMandible	MaxillaMandible	Same
Designoptions	Dental abutments, copings,crowns and bridges. Allowsfor selection of specificNobel Abutment designincluding materialcomposition	Dental abutments, copings,laminates and bridges	The designoptions allows forinclusion of moreinformation in thedesign output inaddition to justdimensions.
Computerformat	PC - Windows based	PC - Windows based	Same
CADcomponent	Integrated	Separate	The CAD modulecontains similarfunctions as thepredicate but isnot integratedinto a singlesystem with scanand orderingmodules
Input	STL file from a scanner	STL file from a scanner	Same(The compatiblescanner hasbeen updatedfrom thepredicate).
Output	Encrypted proprietary format(.NDO file) sent to NobelBiocare manufacturing	Proprietary format (.bcf.c3b file) sent to NobelBiocare manufacturing	The NobelDesignfile format (.NDO)is the only
Criteria	NobelDesign Software(Subject Device)	Procera Software(K053602)Predicate Device	Notes
	facility	facility.	encrypted file.However, both fileformats areproprietary andcontaininformation forthe Nobel Biocaremanufacturingfacility.

5. Comparison of Technological Characteristics

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Discussion:

The identified differences between the submission device and the identified predicate do not affect the substantial equivalence of the device as the changes only allow for the amount and type of information provided by the dental laboratory to Nobel Biocare. The final abutment design and all other screw retained restorations (e.g., abutments, crowns and bridges) will continue to be sent to a Nobel Biocare facility for validation of the design for appropriate dimensions and manufacturing.

6. Testina

The device is designed and manufactured under the Quality System Requlation as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of IEC 62304 (2006) standards.

Design Control Activities including risk management following the ISO 14971 verification/validation testing, was conducted and are included in this submission. The performance of the NobelDesign software was verified and validated following the guidance provided in FDA Guidance General Principles of Software Validation including an entire end-to-end validation (scan, design, and order) for multiple worst-case scenario scan and design requirements This documentation includes testing which demonstrates that the requirements for the features have been met. Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.

7. Substantial Equivalence

Based on the substantial equivalence discussion and software verification //alidation activities described above. NobelDesign Software is substantially equivalent to the identified previously cleared predicate device referenced in this submission.

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.)