SurgiCase Viewer provides functionality to visualize 3D data and to perform measurements on these 3D data, which should allow a clinician to evaluate and communicate about treatment options.

SurgiCase Viewer is intended for use by people active in the medical sector. When used to review and validate treatment options, SurgiCase Viewer is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.

The SurgiCase Viewer can be used by a medical device/service manufacturer/provider or hospital department to visualize 3D data during the manufacturing process of the end-user who is ordering the device/service. This allows the end-user to evaluate and provide feedback on proposals or intermediate steps in the manufacturing of the device or service.

The SurgiCase Viewer is to be integrated with an online Medical Device Data System which is used to process the medical device or service and which is responsible for case management, authorization, authentication, etc.

The data visualized in the SurgiCase Viewer is controlled by the medical device manufacturer using the SurgiCase Viewer in its process. The Device manufacturer will create the 3D data to the end-user and export it to one of the dedicated formats supported by the SurgiCase Viewer. Each of these formats describe the 3D data in STL format with additional meta-data on the 3D models. The SurgiCase Viewer does not alter the 3D data it imports and its functioning is independent of the specific medical indication or product/service it is used for. It's the responsibility of the Medical device company using the SurgiCase Viewer to comply with the applicable medical device regulations.

AI/ML Overview

The Materialise SurgiCase Viewer is a software interface intended for the visualization and communication of treatment options. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results on specific acceptance criteria and performance metrics of the device itself.

Based on the provided text, detailed acceptance criteria and the study proving the device meets them, in the typical format of clinical or standalone performance studies, are not extensively described. The document primarily highlights its non-clinical testing for substantial equivalence.

Here's an attempt to extract and synthesize the requested information, noting where specific details are not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or effect sizes, which are typically seen in clinical performance studies of AI/imaging devices. Instead, the "Performance Data" section refers to "Non-clinical tests" conducted to validate the application for its intended use and determine substantial equivalence.

Acceptance Criterion (Inferred from "Non-clinical tests")	Reported Device Performance (Inferred/Summarized)
Functionality and performance of the SurgiCase Viewer are substantially equivalent to predicate devices (K113599 and K132290).	Non-clinical testing indicated that the subject device is as safe, as effective, and performs as well as the predicates.
Ability to visualize 3D data.	Device provides functionality to visualize 3D data.
Ability to perform measurements on 3D data.	Device provides functionality to perform measurements on 3D data.
Integration with an online Medical Device Data System.	Intended to be integrated with an online Medical Device Data System for case management, authorization, authentication, etc.
Does not alter the 3D data it imports.	The SurgiCase Viewer does not alter the 3D data it imports.
Supports dedicated 3D data formats (e.g., STL with additional meta-data).	Device imports 3D data in STL format with additional meta-data on the 3D models.
Functioning independent of specific medical indication or product/service.	Its functioning is independent of the specific medical indication or product/service it is used for.

2. Sample Size for the Test Set and Data Provenance

The document states "Non-clinical tests" were performed. However, it does not specify the sample size used for any test set (e.g., number of cases, number of 3D models). It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature) as it refers to non-clinical testing, which typically involves technical verification and validation rather than studies on patient data.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set. This is consistent with its focus on non-clinical testing and substantial equivalence rather than a clinical performance evaluation against expert consensus.

4. Adjudication Method for the Test Set

As no expert ground truth or clinical test set is described, there is no mention of an adjudication method (e.g., 2+1, 3+1, none).

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

The document does not describe an MRMC comparative effectiveness study comparing human readers with and without AI assistance. Therefore, no effect size for human improvement is provided.

6. Standalone (Algorithm Only) Performance Study

The document does not present a standalone performance study in terms of typical clinical metrics (e.g., sensitivity, specificity) for the algorithm itself. The "non-clinical tests" relate to the device's functional performance and its equivalence to predicates.

7. Type of Ground Truth Used

The document does not specify a "ground truth" type in the context of expert consensus, pathology, or outcomes data. The validation described is focused on functional and performance equivalence during "non-clinical tests," implying a technical or engineering validation against specified requirements or predicate device behavior.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This aligns with the description of "SurgiCase Viewer" as a software interface for visualization and measurements, suggesting it might not be a machine learning or AI algorithm that requires a traditional training set in the same way. It's more of a tool that processes and displays pre-existing 3D data.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned or implied in the context of machine learning, the document does not describe how ground truth for a training set was established.

Summary

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

May 11, 2017

Materialise NV % Oliver Clemens Regulatory Officer Technologielaan 15 Leuven, 3001 BELGIUM

Re: K170419

Trade/Device Name: SurgiCase Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 30, 2017 Received: April 3, 2017

Dear Oliver Clemens:

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

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

For

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known) K170419

Device Name SurgiCase Viewer

Indications for Use (Describe)

SurgiCase Viewer is intended to be used as a software interface to assist in visualization and communication of treatment options.

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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
	Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov
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510(k) Summary

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92

Company name	Materialise N.V.
Establishment registration number	3003998208
Street Address	Technologielaan 15
City	Leuven
Postal code	3001
Country	Belgium
Phone number	+32 16 39 62 80
Fax number	+32 16 39 66 06
Principal Contact person	Oliver Clemens
Contact title	Regulatory Affairs Officer
Contact e-mail address	Regulatory.Affairs@materialise.be
Additional contact person	Anneleen Van Assche
Contact title	Software Product Manager
Contact e-mail address	Anneleen.VanAssche@materialise.be

Submission date

The date of the Traditional 510(k) submission is May 11, 2017.

Submission information

Trade Name	SurgiCase ViewerMaterialise Viewer
Common Name	Image processing system
Classification Name	System, Image processing, Radiological
Classification product code	LLZ (892.2050)

Predicate Devices

The primary predicate devices to which substantial equivalence is claimed:

Trade or proprietary or model name	SurgiCase Connect for iPad
510(k) number	K113599

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Decision date	April 27, 2012
Classification product code	LLZ (892.2050)
Manufacturer	Materialise N.V.

The secondary predicate device:

Trade or proprietary or model name	SurgiCase Connect
510(k) number	K132290
Decision date	April 10, 2014
Classification product code	PBF (21 CFR 888.3030)
Manufacturer	Materialise N.V.

The reference device:

Trade or proprietary or model name	Materialise TKA Guide System
510(k) number	K150928
Decision date	August 10th, 2015
Classification product code	JWH (21 CFR 888.3560)
Subsequent product codes	MBH, OIY, OOG
Manufacturer	Materialise N.V.

Description and functioning of the device

SurgiCase Viewer provides functionality to visualize 3D data and to perform measurements on these 3D data, which should allow a clinician to evaluate and communicate about treatment options.

The SurgiCase Viewer can be used by a medical device/service manufacturer/provider or hospital department to visualize 3D data during the manufacturing process of the end-user who is ordering the

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device/service. This allows the end-user to evaluate and provide feedback on proposals or intermediate steps in the manufacturing of the device or service.

Intended Use

SurgiCase Viewer is intended to be used as a software interface to assist in visualization of treatment options.

Technological Characteristics

A detailed comparison shows the subject device is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics to the primary predicate devices.

Performance Data

Non-clinical tests

The SurgiCase Viewer application has been validated for its intended use to determine substantial equivalence to the predicate device.

Summary

The characteristics that determine the functionality and performance of the SurgiCase Viewer are substantially equivalent to the devices cleared under K113599 and K132290. The non-clinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicates.

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).