SIMPLANT Online Case Review and SIMPLANT Editor are indicated for use as medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. These are intended for use as preoperative software programs for generating and reviewing plans for dental implant placement and surgical treatment.

Device Description

The proposed devices, SIMPLANT Online Case Review and SIMPLANT Editor, are software intended for pre-operative planning to generate and review plans for dental implant placement and surgical treatment, without patient contact.

SIMPLANT Online Case Review is a web application used for review and approval of dental implant plans provided by DENTSPLY Implants. SIMPLANT Online Case Review can also be used in combination with the desktop software application SIMPLANT Editor when an implant plan, provided by DENTSPLY Implants, is edited by the dental professional.

The software SIMPLANT Online Case Review and SIMPLANT Editor are used by dental professionals with clinical experience in implant surgery as well as training in medical image review.

Implant plans, in the format of SIMPLANT project files are created by DENTSPLY Implants and made available to the dental professional. The SIMPLANT project is created by DENTSPLY Implants using dental professional supplied patient image data, patient information and implants data developed by DENTSPLY Implants which are merged together. The SIMPLANT project is the basis for implant surgery planning by dental professionals.

The dental plan, which is the result of the dental implant planning process, can be used for manufacturing a surgical guide or for evaluation of treatment options by the dental professional during the implant surgery procedure.

AI/ML Overview

This document describes the SIMPLANT Online Case Review and SIMPLANT Editor devices, focusing on their intended use as medical front-end software for dental implant planning and review. Unfortunately, the provided text does not contain the specific details about acceptance criteria or a dedicated study proving device performance against those criteria in a quantitative manner.

However, it does describe the software testing performed as part of the verification and validation process, which generally aims to ensure functionality and compatibility.

Here's an attempt to answer your questions based on the available information, with specific notes where information is missing:

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

The document does not explicitly state specific quantitative acceptance criteria for device performance (e.g., accuracy, precision as defined by a specific metric and threshold). It mentions that "Verification and validation testing confirms that all user needs and performance requirements according to the design input are fulfilled." This suggests that acceptance criteria would be tied to these "user needs and performance requirements," but these are not detailed in the provided text.

The "reported device performance" is described broadly as confirming "the functionality, safety and efficacy of the proposed devices" and that they are "substantially equivalent" to the predicate. No numerical performance metrics are given.

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

This information is not provided in the document. The text states:

"The SIMPLANT project is created by DENTSPLY Implants using dental professional supplied patient image data, patient information and implants data developed by DENTSPLY Implants which are merged together."

This indicates that patient image data is used, but details on the size, origin, or nature (retrospective/prospective) of this data for the test set are absent.

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. The text mentions "dental professionals with clinical experience in implant surgery as well as training in medical image review" will use the software, but it doesn't specify if such experts were involved in establishing ground truth for testing, or if so, how many or their specific qualifications.

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

This information is not provided in the document. The document focuses on the software as a tool for planning and review, implying human-in-the-loop, but does not describe any MRMC studies comparing human performance with and without the device. The device itself is described as "medical front-end software," not an AI-assisted diagnostic tool in the sense of providing automated interpretations.

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

The devices, SIMPLANT Online Case Review and SIMPLANT Editor, are described as "medical front-end software" and tools for "visualizing gray value images" and "generating and reviewing plans for dental implant placement and surgical treatment" by "medically trained people" and "dental professionals." This strongly suggests a "human-in-the-loop" application, not a standalone algorithm without human involvement. Therefore, a standalone performance study as typically understood for an AI algorithm is unlikely to have been performed or necessary for this type of device based on its description.

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

This information is not explicitly provided in the document. Given the nature of the device (pre-operative planning), ground truth would typically refer to the correctness of the implant plan or the visualizations. However, how this correctness was established for testing is not detailed.

8. The sample size for the training set

Given that SIMPLANT Online Case Review and SIMPLANT Editor are described as software for visualizing, generating, and reviewing plans, and their predicate's functions largely involve image processing and 3D modeling, it's unclear if a "training set" in the context of machine learning (AI) was even used. The document does not mention machine learning or AI models, but rather standard software development and verification processes.

If there were indeed any underlying machine learning components, the size of a training set is not provided.

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

As it's unclear if a training set for machine learning was used, the method for establishing its ground truth is also not provided. The "SIMPLANT project files are created by DENTSPLY Implants," based on "dental professional supplied patient image data, patient information and implants data." This describes the workflow for generating the project files that the devices then interact with, rather than how a training set for an AI model would be established.

Summary of what is present and what is missing:

Acceptance Criteria/Performance Data: Not explicitly detailed with quantitative metrics. Performance is broadly stated as confirming functionality, safety, and efficacy, and achieving substantial equivalence.
Sample Size (Test Set), Data Provenance: Not provided.
Expert Ground Truth (Test Set): Not provided (number or qualifications).
Adjudication Method: Not provided.
MRMC Study: Not described.
Standalone Performance: The devices are human-in-the-loop; a standalone algorithm study (without human involvement) is not described and likely not applicable in the typical sense for this device.
Type of Ground Truth: Not explicitly stated.
Sample Size (Training Set): Not provided, and it's unclear if a "training set" in the ML sense is applicable.
Ground Truth (Training Set): Not provided.

The document primarily focuses on establishing "substantial equivalence" to a predicate device (Simplant 2011) based on similar indications for use and fundamental functions, along with general software verification and validation activities. The emphasis is on the software's role as a tool rather than its performance as an autonomous or AI-driven diagnostic system.

Summary

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

July 28, 2016

Dentsply Sirona % Ms. Helen Lewis Director, Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60 YORK PA 17404

Re: K161118

Trade/Device Name: SIMPLANT Online Case Review and SIMPLANT Editor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 7, 2016 Received: July 8, 2016

Dear Ms. Lewis:

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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Indications for Use

510(k) Number (if known) K161118

Device Name

SIMPLANT Online Case Review and SIMPLANT Editor

Indications for Use (Describe)

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

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SECTION 5. 510(k) SUMMARY

for

SIMPLANT Online Case Review and SIMPLANT Editor

Submitter Information: 1.
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404

Contact Person:	Helen Lewis
Telephone Number:	717-487-1332
Fax Number:	717-849-4343

Date Prepared: April 15, 2016

1. Device Name:

Proprietary Name:	SIMPLANT Online Case Review and SIMPLANT Editor
Classification Name:	Picture Archiving and Communication System
CFR Number:	21 CFR §892.2050
Device Class:	Class II
Product Code:	LLZ

3. Predicate Device:

The medical device SimPlant 2011 was selected as the predicate device for this submission for the proposed devices SIMPLANT Online Case Review and SIMPLANT Editor. Simplant 2011 is designed, developed and manufactured by DENTSPLY Implants NV (formerly Materialise Dental NV) and cleared for the US market in K110300.

4. Description of Device:

The software SIMPLANT Online Case Review and SIMPLANT Editor are used by dental professionals with clinical experience in implant surgery as well as training in medical image review.

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ડ. Indications for Use:
SIMPLANT Online Case Review and SIMPLANT Editor are indicated for use as medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. These are intended for use as preoperative software programs for generating and reviewing plans for dental implant placement and surgical treatment.
1. Substantial Equivalence:
  Technological characteristics

The proposed devices, SIMPLANT Online Case Review and SIMPLANT Editor, are stand-alone medical device software used without patient contact.

Element	Proposed Devices		Predicate Device	Difference
	SIMPLANTOnline CaseReview	SIMPLANTEditor	Simplant 2011(K11300)
Indicationsfor Use	SIMPLANT Online Case Reviewand SIMPLANT Editor areindicated for use as medical front-end software that can be used bymedically trained people for thepurpose of visualizing gray valueimages. These are intended for useas pre-operative software programsfor generating and reviewing plansfor dental implant placement andsurgical treatment.		Simplant 2011 is intended foruse as a software interface andimage segmentation system forthe transfer of imaginginformation from a medicalscanner such as a CT scanner ora Magnetic Resonance scanner.It is also intended as pre-planning software for dentalimplant placement and surgicaltreatment.	Yes
IntendedPurpose	Review andapprove implantplan	Edit implantplan forapproval inOnline CaseReview.	Create, edit and approve implantplan.	Yes
Function			Volume Rendering	Yes
			Segmentation Wizard	Yes
			Reorient axial images to occlusal plane	Yes
			Advanced virtual teeth	Yes
			Advanced grafts and Volumes	Yes
			Dual scan registration	Yes
Element	Proposed Devices		Predicate Device	Difference
	SIMPLANTOnline CaseReview	SIMPLANTEditor	Simplant 2011(K11300)
			Optical scan registration	Yes
			Occlusion tool	Yes
			Virtual occludator*	Yes
			Advanced soft tissue simulation	Yes
			Surgical guide wizard	Yes
	Open project	Open project	Open project	No
		Save project	Save project	No
	Load project		Load project	No
	3D viewing	3D viewing	3D viewing	No
	2D gray value images	2D gray value images	2D gray value images	No
	Navigation	Navigation	Navigation	No
			Review and accept nerve	Yes
	Distance	Distance	Distance	No
	Geometrypresentation	Geometrypresentation	Geometry presentation	No
	Measurements	Measurements	Measurements	No
	Review implants	Review implants	Review implants	No
		Edit implants	Edit implants	No
		Change implant	Change implant	No
	Collision detection	Collision detection	Collision detection	No
	Approve plan		Approve plan	No
Media forDelivery	Web application	Software-Filefor download	Software-Magnetic media	Yes
Principles ofoperation	Web application	Desktopsoftwareapplication	Desktop software application	Yes
Programlanguage	C#	C++	C++	Yes
OperatingSystem	Windows	Windows	Windows	No

Table 5-1 Substantial equivalence comparison table

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*Occludator means a function to visualize how the upper and lower jaw will come together when the mouth is closed.

Analysis of differences

The proposed devices compared to the predicate have similar indications for use and partly the same basic functionalities. The first 11 functions listed in Table 5-1 for the predicate device are used during creation of an implant plan, which will not be performed with any of the proposed devices. The differences here are due to the proposed devices', SIMPLANT Online Case Review and SIMPLANT Editor's dependency to a pre-created implant plan made by DENTPLY Implants.

The 'Review and accept nerve' function is no longer included in the software applications as a separate function. For the proposed devices, SIMPLANT Online Case Review and SIMPLANT Editor, the nerve is accepted implicitly when the complete dental implant plan is approved by the dental professional.

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The differences in principles of operation and media for delivery are due to the simplification of the review process for the dental professional allowing them to view implant plans in the web application SIMPLANT Online Case Review. This does not require transfer of all the data in the implant plan to a local computer nor is a local installation of a software application required.

The differences in programming languages are also due to principles of operation and the fact that SIMPLANT Online Case Review is a web application. For this reason. C# is selected for its suitability to support development of web applications.

1. Software testing
  Software verification and validation was conducted to ensure the functionality and compatibility of all system components and to support the safety and effectiveness of the proposed devices.

The software testing has been compared to the predicate device, Simplant 2011 (K110300), image accuracy testing and tests applied in accordance with the software life cycle processes, as defined in IEC 62304.

The verification and validation testing consists of the following activities:

Unit test
Peer Code Review
Integration test ●
Internal release test ●
Smoke test
Formal system test
Acceptance test ●
Beta test ●

Verification and validation testing confirms that all user needs and performance requirements according to the design input are fulfilled. The comparison tests confirm the functionality, safety and efficacy of the proposed devices.

8. Conclusion Regarding Substantial Equivalence

The SIMPLANT Online Case Review and SIMPLANT Editor are dental software which are intended for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. The SIMPLANT Online Case Review and SIMPLANT Editor are intended for use as pre-operative software programs for generating and reviewing plans for dental implant placement and surgical treatment.

The SIMPLANT Online Case Review and SIMPLANT Editor have similar indications for use and incorporate the same fundamental functions as the predicate device SimPlant 2011 cleared under premarket notification K110300. Test data to verify the performance of the SIMPLANT Online Case Review and SIMPLANT Editor have been provided, where the results of this testing, combined with the comparison to the predicate device, support substantial equivalence and do not raise any new issues of safety or effectiveness.

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).