SurgiCase is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner.

Device Description

This submission is a Traditional 510(k) for the Orthognathic wizard of SurgiCase software application.

Based on the software planning several options are available to transfer the result of the planning to surgery. Examples:

The software planning can be used to select appropriate implants or implant sizes for use during surgery.
. Based on the planning, patient-specific surgical guides and implants can be designed.
. Patient-specific surgical splints can be generated to transfer the planned dental occlusion to surgery.

The SurgiCase software platform is the basis of all clinical Materialise software designed for surgery planning. The platform allows basic functionality such as visualizing 3D objects, visualizing medical image data, generating 3D objects from medical image data and measuring.

On top of this platform, modules, also called wizards, can be added that each offer additional functionality such as planning a specific surgical routine. This platform is the main general wizard, while additional modules (wizards) are mainly based on the functionality of this general wizard; they assist the surgeon to plan specific surgery types step-by-step by providing each a different user interface, giving the surgeon the opportunity to fine tune parameters specific for that type of surgery. Current premarket notification is only for the Orthognathic wizard of the SurgiCase software. The rest of software wizards have been cleared under K073449 submission for the SurgiCase software.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SurgiCase Orthognathic software wizard, based on the information available in the 510(k) summary:

Summary of Device Acceptance Criteria and Performance Data (Based on this 510(k) Pre-submission Documentation):

Based on the provided 510(k) summary, the device's acceptance criteria primarily revolve around its equivalence to its predicate device (SurgiCase, K073449) and successful completion of non-clinical software verification and validation. There are no explicit, quantifiable acceptance criteria or reported performance metrics in the provided text other than the successful completion of these non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Equivalence to Predicate Device (SurgiCase K073449) in:
* Intended Use	Achieved (stated in "Summary of technological characteristics" and implied by FDA clearance)
* Materials	Achieved (stated in "Summary of technological characteristics")
* Performance Characteristics	Achieved (stated in "Summary of technological characteristics")
Software Verification and Validation Testing:
* Completion of Verification and Validation Reports	"Will be completed by the end of August 2011. Verification and validation reports will be on file at Materialise from that point on and can be sent on request." (Indicates an intent to meet, and subsequently FDA clearance implies it was met)

Missing Information/Caveats: The document explicitly states that "Software verification and validation testing will be completed by the end of August 2011." While the FDA's clearance letter implies these were successfully completed and reviewed, the detailed reports themselves are not part of this public summary. Therefore, specific quantifiable acceptance criteria (e.g., accuracy, precision, processing time) and their corresponding performance values from these internal tests are not provided in this document. The "reported device performance" in the table above is inferred from the FDA's clearance.

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

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The document states the software uses "imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging (MRI) scanner," but does not mention the origin (country, specific hospitals) or nature (retrospective/prospective) of any specific data used for testing or validation.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set:

Adjudication Method: Not specified.

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:

MRMC Study: No. The document explicitly states "Clinical testing: Not applicable." This indicates that no studies comparing human readers with and without AI assistance were conducted or submitted as part of this 510(k).

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

Standalone Performance: The 510(k) summary only mentions "Software verification and validation testing." While these tests likely assessed the algorithm's performance in isolation (standalone), the specific details of these tests, including the metrics and results, are not provided in this document. The document primarily focuses on the regulatory submission process and substantial equivalence, not detailed technical performance studies.

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

Type of Ground Truth: Not specified. Given the absence of detailed clinical or performance studies, the specific type of ground truth used for any internal software testing is not available in this summary.

8. The sample size for the training set:

Sample Size for Training Set: Not specified. This type of detail, if applicable to the software's development (e.g., for machine learning components, which are not explicitly mentioned but could be part of "image processing"), is not included in this 510(k) summary.

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

Ground Truth for Training Set: Not specified.

Summary

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510(k) Summary

Submitter information

Company name	Materialise N.V.
Establishment registration number	3003998208
Street Address	Technologielaan 15
City	Leuven
Postal code	3001
Country	Belgium
Phone number	+32 16 74 45 37
Fax number	+32 16 39 66 06
Principal contact name	Oliver Clemens
Contact title	Quality & Regulatory officer
Contact e-mail address	oliver.clemens@materialise.be
Additional contact name	Alexandra Razzhivina
Contact title	Regulatory officer
Contact e-mail address	alexandra.razzhivina@materialise.be
Additional contact name	Dieter Vandoren
Contact title	Continuous Improvement Manager CMF
Contact e-mail address	Dieter.vandoren@materialise.be

Submission date

The date of the Traditional 510(k) submission is June 10th, 2011

Submission information

Trade Name	SurgiCase, SurgiCase CMF, ProPlan CMF
Common Name	Image processing system and software forsimulating/evaluating implant placement and surgicaltreatment options
Classification Name	System, Image processing, Radiological
Product code	LLZ (21 CFR 892.2050)

Predicate device

Trade or proprietary or model name	SurgiCase
510(k) number	K073449
Decision date	2008/04/16
Product code	LLZ
Manufacturer	Materialise N.V.

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Device Information

Description of the device

This submission is a Traditional 510(k) for the Orthognathic wizard of SurgiCase software application.

Based on the software planning several options are available to transfer the result of the planning to surgery. Examples:

The software planning can be used to select appropriate implants or implant sizes for use during surgery.
. Based on the planning, patient-specific surgical guides and implants can be designed.
. Patient-specific surgical splints can be generated to transfer the planned dental occlusion to surgery.

Functioning of the device

Intended use

² The surgical splints are Class I, 510k exempt and therefore are not submitted for review in this 510k submission. References to the splints are provided as an example throughout this submission to give a complete overview on the whole process (from planning to surgery).

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Summary of technological characteristics

Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate device.

Performance data

Non-clinical testing

Software verification and validation testing will be completed by the end of August 2011. Verification and validation reports will be on file at Materialise from that point on and can be sent on request.

Clinical testing

Not applicable.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Oliver Clemens Quality and Regulatory Officer Materialise NV Technologielaan 15 3001 Leuven BELGIUM

SEP 26 2011

Re: K111641

Trade/Device Name: SurgiCase Orthognathic software Wizard Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: H Product Code: L.L.Z Dated: September 1, 2011 Received: September 2, 2011

Dear Mr. 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.

If your device is classified (see above) into class II (Special Controls). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safery at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: SurgiCase Orthognathic software wizard

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _1

, "

Mary Stated

(Division Sign-Division f Radiological Devic Office of In Vitro Djagr

K111 641
510K

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).