NobelClinician® (DTX Studio Implant) is a software interface for the transfer and visualization of 2D and 3D image information from equipment such as a CT scanner for the purposes of supporting the diagnostic process, treatment planning and follow-up in the dental and cranio-maxillofacial regions.

NobelClinician® (DTX Studio Implant) can be used to support guided implant surgery and to provide design input for and review of dental restorative solutions. The results can be exported to be manufactured.

Device Description

NobelClinician® is a software interface used to support the image-based diagnostic process and treatment planning of dental, cranio-maxillofacial, and related treatments. The product will also be marketed as DTX Studio implant.

The software offers a visualization technique for (CB)CT images of the patient for the diagnostic and treatment planning process. In addition, 2D image data such as photographic images and X-ray images or surface scans of the intra-oral situation may be visualized to bring diagnostic image data together. Prosthetic information can be added and visualized to support prosthetic implant planning. The surgical plan, including the implant positions and the prosthetic information, can be exported for the design of dental restorations in NobelDesign® (DTX Studio design).

Surgical planning may be previewed using the software and the related surgical template may be ordered.

AI/ML Overview

This document is a 510(k) premarket notification summary for the NobelClinician® (DTX Studio Implant) software. The information provided heavily focuses on regulatory comparisons to a predicate device rather than detailed study protocols and results for meeting specific acceptance criteria in a typical clinical performance study.

Based on the provided text, the device is a "Picture archiving and communications system" (PACS) software, classified under 21 CFR 892.2050. The performance data presented are primarily non-clinical.

Here's an attempt to answer your questions based only on the provided text:

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

The document does not explicitly present a table of acceptance criteria and reported device performance in the manner typically found in a clinical study report. Instead, it states that "Software verification and validation per EN IEC 62304:2006" was performed. This implies that the acceptance criteria would be related to the successful completion of these verification and validation activities, demonstrating that the software meets its specified requirements and is fit for its intended use, as defined by the standard.

Since specific performance metrics (e.g., accuracy, precision) for diagnostic or treatment planning tasks are not quantified or presented in this regulatory summary, a table showing such criteria and performance cannot be constructed from this document.

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 does not provide details on the sample size used for a test set or the provenance of any data beyond indicating "non-clinical studies". This suggests that a traditional clinical test set with patient data for evaluating performance metrics was not the focus of the "performance data" section in this 510(k) summary. The listed activity "Software verification and validation per EN IEC 62304:2006" typically involves testing against synthetic data, simulated scenarios, or existing clinical datasets used for functional and performance testing of software, rather than a prospective clinical study with a defined "test set" in the sense of patient cases.

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)

This information is not provided in the document. Given that the performance data mentioned refers to "Software verification and validation per EN IEC 62304:2006," it is unlikely that a formal ground truth establishment by a panel of clinical experts for a test set (as in a diagnostic accuracy study) was conducted or reported in this summary.

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

This information is not provided in the document.

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 any multi-reader multi-case (MRMC) comparative effectiveness study. The "performance data" section is limited to "Non-Clinical Studies - Software verification and validation per EN IEC 62304:2006".

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

The document does not explicitly state whether a standalone algorithm-only performance study was conducted. The device is described as "a software interface for the transfer and visualization of 2D and 3D image information from equipment... for the purposes of supporting the diagnostic process, treatment planning and follow-up...". This indicates a human-in-the-loop context for its intended use. The verification and validation activities would assess the software's functional correctness for these tasks.

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

Since the document only refers to "Software verification and validation per EN IEC 62304:2006" as performance data, the specific type of "ground truth" used for these non-clinical tests is not detailed. For software testing, ground truth could involve:

Pre-defined expected outputs for given inputs.
Comparisons to known good results from previous versions or manually calculated values.
Adherence to specifications and design requirements.
Formal clinical ground truth (like pathology or outcomes data) is not mentioned.

8. The sample size for the training set

This document does not indicate that the device involves AI/machine learning requiring a "training set" in the conventional sense. The "performance data" refers to software verification and validation, which focuses on the deterministic functionality of the software according to its specifications, not statistical learning from data.

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

As there is no mention of an AI/machine learning component requiring a training set, this information is not applicable and not provided in the document.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based primarily on non-clinical software verification and validation activities. It does not contain detailed information about a clinical performance study with specific acceptance criteria, test sets, expert ground truth establishment, or comparative effectiveness studies of the type you've inquired about.

Summary

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

January 31, 2017

Nobel Biocare AB % Chalemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway YORBA LINDA CA 92887

Re: K163122

Trade/Device Name: NobelClinician®, DTX Studio Implant Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 7, 2016 Received: November 8, 2016

Dear Chalemagne 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 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.

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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/Resourcesfor You/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.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No.	0910-0120
Expiration Date:	January 31, 2017
	See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known)	K163122
Device Name	NobelClinician(R)
	DTX Studio Implant

Indications for Use (Describe)

NobelClinician® (DTX Studio Implant) is a software interface for the transfer and visualization of 2D and 3D image
information from equipment such as a CT scanner for the purposes of supporting the diagnostic process, treatment
planning and follow-up in the dental and cranio-maxillofacial regions.

NobelClinician® (DTX Studio Implant) can be used to support guided implant surgery and to provide design input for and
review of dental restorative solutions. The results can be exported to be manufactured.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)	Page 1 of 1
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1.0 510(k) Summary

Submitter I.

Submitted by:

Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x7830 Fax: (714) 998-9348

Submitted for:

Nobel Biocare AB Vastra Hamngatan 1 Goteburg, SE-411 17 Sweden

Date Prepared: January 11, 2017

II. Device

Device Proprietary Name(s):

Trade Name No. 1:	NobelClinician®
Trade Name No. 2:	DTX Studio Implant
Common or Usual Name:	Picture Archiving and Communications System
Classification Name:	System, Image Processing, Radiological
Regulation Number:	21 CFR 892.2050
Product Code:	LLZ
Device Classification	2

III. Predicate Device

Substantial equivalence is claimed to the following device:

. NobelClinician®, K123976, Nobel Biocare AB

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The following reference devices are cited within the submission:

Implant Studio 2015, K152078, 3Shape Medical A/S ●
coDiagnostix Implant Planning Software, K130724, Straumann USA
Simplant 2011, K110300, Materialise Dental NV
Swissmeda Dental Planning System, K112251, Swissmeda AG ●
InVivo Dental, K123519, Anatomage, Inc. ●

IV. Device Description

Surgical planning may be previewed using the software and the related surgical template may be ordered.

V. Indications for Use

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VI. Comparison of Technological Characteristics

NobelClinician® and the predicate device share the following characteristics:

Treatment of same anatomic areas (maxilla, mandible, and cranio-maxillofacial)
. Patient data management features
3D planning environment ●
Creation of surgical templates (through a radiographic guide workflow) ●
Communication module (data sharing capability) using NobelConnect and ● NobelClinician® Viewer
. Order module
. Support of the NobelGuide1 clinical concept for oral rehabilitation based on dental implants.

NobelClinician® is technologically different from the predicate device as follows:

. Acceptance of surface data from the intraoral situation. This surface information is aligned to DICOM data to support the prosthetic implant planning and guided surgery protocols.
For partially edentulous patients, the shape of missing teeth is automatically designed
Creation of surgical template based on intraoral surface data
Export of the surgical template design to be manufactured ●
. Export of the treatment plan for dental restoration design in NobelDesign® (DTX Studio design)
Option to design surgical templates for fully guided implant insertion or pilot drill ●
. Volume based matching of data such as voxel base matching of (CB)CT (e.g. for postop evaluation), and surface alignment of 3D data

A comparison of the subject and predicate devices is provided in the table below.

Parameter	NobelClinician®	NobelClinician®(K123976)
Indications forUse Statement	NobelClinician® (DTX StudioImpant) is a software interfacefor the transfer and visualizationof 2D and 3D image informationfrom equipment such as a CTscanner for the purposes ofsupporting the diagnostic process,	The NobelClinician® software is asoftware interface for the transferand visualization of imaginginformation from equipment suchas a CT scanner or a magneticresonance scanner for thepurposes of diagnosis and
	treatment planning and follow-upin the dental and cranio-maxillofacial regions.NobelClinician® (DTX StudioImplant) can be used to supportguided implant surgery and toprovide design input for andreview of dental restorativesolutions. The results can beexported to be manufactured.	treatment planning in the dentaland cranio-maxillofacial regions.The NobelClinician® software canbe used to design a surgicaltemplate for the purposes ofaiding placement of dentalimplants.
Anatomic Areas	MaxillaMandibleCranio-maxillofacial	MaxillaMandibleCranio-maxillofacial
Input	DICOM data from (CB)CTscannerDigital data of the intraoralsituation (open file format suchas STL)NXA format (proprietary format)	DICOM data from (CB)CTscannerN/AN/A
SoftwareFeatures	Create and manage planningscenarios and treatmentsCreate and edit 3D ModelsAlignment of radiographic guideand patient modelAdding an implant, abutmentsand anchor pins to a planningSurgical template creation fromradiographic guideAlignment of intraoral surfacedata (proprietary or open format)with (CB)CT dataAutomatic tooth setup designSurgical template calculationfrom intraoral surface dataPilot drill sleevesVolume based matching of data(such as voxel base matching of	Create and manage planningscenarios and treatmentsCreate and edit 3D ModelsAlignment of radiographic guideand patient modelAdding an implant, abutments andanchor pins to a planningSurgical template creation fromradiographic guideN/AN/AN/AN/AN/A
	(CB)CT data, surface alignmentof 3D data)
Data Sharing	NobelConnectNobelClinician® ViewerNobelDesign® (DTX Studio design)	NobelConnectNobelClinician® Viewer
Output	Export surgical template designfor centralized production inNobel Biocare facilities	Export surgical template designfor centralized production inNobel Biocare facilities
	Export surgical template design(proprietary or open format) to bemanufactured	N/A
	Export treatment plan for dentalrestoration design inNobelDesign® (DTX Studio design)	N/A

Design Options	DiagnosticsProsthetic driven surgicalplanning for dental implantsCreation of surgical templatesfrom a radiographic guide orintraoral surface dataTreatment plan exchange withNobelDesign® (DTX Studiodesign) for dental restorationdesignPost-op evaluation – compare preand post op (CB)CT scans usingvolume base matching	DiagnosticsProsthetic driven surgicalplanning for dental implantsCreation of surgical templatesfrom a radiographic guideN/AN/A




ComputerFormat	PC – Windows basedMAC - OS	PC – Windows basedMAC - OS

1See Section 9.3

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Discussion

As seen above, the subject and predicate devices have similar indications for use statements. Slight differences in wording allow for clarity and align with the added functionality within the subject device. These changes in the indications for use statement do not alter the intended use of the product.

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Added software features within the subject device provide users with more flexibility and options to support the diagnostic process and treatment planning. These technological differences are addressed by the performance data identified below and do not raise different questions of safety or effectiveness.

VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Studies

Software verification and validation per EN IEC 62304:2006 ●

VIII. Conclusion

Although minor differences in design and technology exist between the subject and predicate device, the testing cited above supports these differences. Therefore, it is concluded that the NobelClinician® is substantially equivalent to the predicate devices.

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Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).