The SurgiCase Orthopaedics system is intended to be used as a surgical instrument to assist in pre-operative planning and/or in guiding the marking of bone and/or guide surgical instruments in non-acute, non-joint replacing osteotomies for upper extremity orthopedic surgical procedures and osteotomies around the knee.

The system is to be used for adult patients.

SurgiCase Guides are intended for single use only.

Device Description

The SurgiCase Orthopaedics system is intended to be used as a surgical instrument to transfer a pre-surgical plan to the surgery with osteotomies on upper extremity orthopedic procedures anound the knee.

The SurgiCase Orthopaedics system is components: SurgiCase Connect (software) and SurgiCase Guides (hardware).

SurgiCase Connect is a medical device for Materialise and a surgeon for pre-surgical simulation of surgical treatment options. This includes transfering, visualizing, measuring, annotating and editing medical data.

The SurgiCase Guides are patient specific templates that are designed and manufactured based on a pre-surgical software plan for a specific patient. In surgery these guides are used to assist a surgeon in guiding the marking of bone and/or guiding surgical instruments to cut and drill according to the pre-surgical plan.

All guides are individually designed and manufactured for each patient using a design and manufacturing process with strict procedures and work instructions to guarantee guides that consistently perform in a safe and effective way. Part of this process is a scientific Stability Model which measures the sensitivity of a guide to movement during surgery. The use of this Stability Model ensures a stable position on the patient's anatomy for accurate guiding of surgical instruments. The Stability Model is anatomy independent, thus it can be applied to any bony structure in upper extremity surgical procedures and osteotomies around the knee.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria Category | Specific Test/Study | Reported Device Performance and Acceptance |
| :--------------------------- | :------------------------------------------------ |
| Accuracy | Bone Model Tests | "All results were within the preset acceptance criteria." (Specific numerical criteria not provided) |
| Accuracy | Cadaveric Tests | "All results were within the preset acceptance criteria." (Specific numerical criteria not provided) |
| Safety & Effectiveness | Biocompatibility Test | "Testing verified that the accuracy and performance of the device is adequate to perform as intended." |
| Safety & Effectiveness | Sterilization Dimensional Stability Test | "Testing verified that the accuracy and performance of the device is adequate to perform as intended." |
| Safety & Effectiveness | Cleaning Validation Test | "Testing verified that the accuracy and performance of the device is adequate to perform as intended." |
| Safety & Effectiveness | Packaging and Shipment Test | "Testing verified that the accuracy and performance of the device is adequate to perform as intended." |
| Stability/Fit | Scientific Stability Model | "Ensures the most stable position on the patient's anatomy for accurate guiding of surgical instruments." |
| Software Functionality | Internal and External User Testing & Observations | "Results from this verification and validation testing demonstrate the device's safety and effectiveness is substantially equivalent to the predicate device." |
| Clinical Efficacy | Retrospective Analysis of Clinical Cases (Europe) | "Confirms the subject device's safety and effectiveness is substantially equivalent to the predicate device for use as intended based on surgeon evaluation of expected outcome." |

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

Bone Model Tests: "On a series of femoral and tibial models" (Specific number of models not provided).
Cadaveric Tests: "On a series of cadaveric specimens" (Specific number of specimens not provided).
Retrospective Clinical Cases: "Retrospective analysis of clinical cases performed in Europe" (Specific number of cases not provided).

3. Number of Experts Used to Establish Ground Truth and Qualifications

For the bone model and cadaveric tests, the "pre-operative planned versus achieved corrected models/specimens were compared." This implies a comparison to a pre-defined plan or standard, rather than a consensus among external experts. The qualifications of who established the "pre-operative plan" and conducted the comparison are not explicitly stated, but it would typically be engineers or qualified personnel involved in the device development.
For the retrospective clinical cases, "surgeon evaluation of expected outcome" was used. The number and specific qualifications of these surgeons are not provided, other than them being clinical users in Europe.

4. Adjudication Method for the Test Set

The document implies a comparison of achieved results against "preset acceptance criteria" for the non-clinical tests. This suggests a direct measurement against a standard, rather than a multi-expert adjudication process.
For the retrospective clinical cases, the ground truth was based on "surgeon evaluation of expected outcome," which might implicitly involve some level of individual surgeon judgment rather than a formal adjudication panel. No specific adjudication method like 2+1 or 3+1 is mentioned.

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

No MRMC comparative effectiveness study is mentioned that assesses how much human readers improve with AI vs without AI assistance. The device is a surgical planning and guiding system, not an AI for image interpretation that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

A standalone performance was implicitly conducted for the SurgiCase Connect software component through "internal and external user testing and observations" and verification against specifications.
The SurgiCase Guides were validated through "bone model tests" and "cadaveric tests," which involved applying the guides according to a pre-operative plan and comparing the achieved corrected models/specimens to the planned ones. This represents a standalone performance assessment of the guide's accuracy in transferring the surgical plan.

7. Type of Ground Truth Used

Non-clinical tests (Bone models, Cadavers): "Pre-operative planned" outcomes served as the ground truth against which the achieved corrected models/specimens were compared. This is an engineered or defined ground truth.
Retrospective Clinical Study: "Surgeon evaluation of expected outcome" served as the ground truth. This is a form of expert clinical judgment/outcome data.

8. Sample Size for the Training Set

The document does not provide explicit information on the sample size used for a "training set." The device is primarily a software system for planning and physical guides for execution, rather than a machine learning algorithm that typically undergoes a separate supervised training phase with a dedicated training set. The descriptions focus on verification and validation against specifications and clinical use.

9. How Ground Truth for the Training Set Was Established

As no explicit training set is mentioned in the context of a machine learning algorithm, the method for establishing its ground truth is not applicable or described in this document. The "training" for such a system would involve software development, engineering, and iterative testing/refinement against design specifications and user feedback, rather than a formal ground truth for a machine learning model.

Summary

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APR 1 0 2014

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
Contact name	Oliver Clemens
Contact title	Quality and Regulatory officer
Contact e-mail address	regulatory.affairs@materialise.be

Submission date

The date of the Traditional 510(k) submission is 19th of July, 2013.

Submission information

Trade Name	SurgiCase Orthopaedics system, SurgiCase Connect, SurgiCase Guides
Common Name	Orthopaedic surgical planning and instruments guide
Classification Name	Orthopaedic surgical planning and instruments guide
Product code	PBF

Predicate devices

Trade or proprietary or model name	SurgiCase Orthopaedics system
510(k) number	K112389
Decision date	07/20/2012
Product code	PBF
Manufacturer	Materialise N.V.

Device Information

Description and functioning of the device

The SurgiCase Orthopaedics system is components: SurgiCase Connect (software) and SurgiCase Guides (hardware).

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Intended use

The system is to be used for adult patients.

SurgiCase Guides are intended for single use only.

Summary of technological characteristics

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

· Both subject device and predicate device are to be used as a surgical instrument to assist the surgeon in preoperative planning and evaluation of surgical treatment options.
· The guides of the subject and predicate devices are intended to guide the marking of bone and/or guiding the surgical instruments in surgical procedures.
· The guides of the subject and predicate devices are designed and manufactured from reconstructed threedimensional models of the patient's anatomy.
The guides of the subject and predicate devices are made of the same material and follow the same manufacturing process.
The guide performance of subject and predicate device is guaranteed once the stable fit of the guide on the patient's anatomy is obtained, no matter the shape of the bone.
· Both subject device and predicate device use the same scientific Stability Model to ensure the most stable fit of the guide on the patient's anatomy.
The software component of the subject and predicate device are intended for use as medical device for Materialise and a surgeon for pre-surgical simulation of surgical treatment options, which includes transferring, visualizing, measuring, annotating and editing medical data.
The software component of the subject device is the same software component of the predicate device, only updated with user interface improvements and minor functional additions.
· The software component of the subject and predicate device functions exactly the same.
The software component of the subject and predicate device utilized the same programming language and operating system.
The guides and software of the subject and predicate device have been developed by the same manufacturing company (Materialise NV), based on the same fundamental technology and in-house knowledge and followed the same internal quality procedures and work instructions for design, development, testing and validation.

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The only difference is the surgical region where the guides will be applied: lower extremity around the knee for the subject device versus upper extremity for the predicate device. There is no functional difference between the subject and predicate device guides are able to obtain a similar level of performance for both predicate and subject device. The difference between the subject device and the predicate device does not affect the safety and effectiveness of the device when used as labeled.

Performance data

Non-clinical testing

The SurgiCase Connect software has been validated for its intenal and external user testing and observations. Verification tests are derived from the specifications and ensures that all controls are functioning properly. The results from this verification and validation testing demonstrate the device's salety and effectiveness is substantially equivalent to the predicate device for use as intended.

SurgiCase Guides were validated through non-clinical studies using bone models and cadaver specimens:

Bone model tests: On a series of femoral and tibial models, Surgicase Guides were designed and applied according to a pre-operative planned versus achieved corrected models were compared. All results were within the preset acceptance criteria.
- Cadaveric tests: On a series of cadaveric specimens, Surgicase Guides were designed and applied according to a pre-operative plan. The planned versus achieved corrected specimens were compared. All results were within the preset acceptance criteria.

Biocompatibility test, sterilization dimensional stability test, cleaning validation test and packaging and shipment test were performed to assess the safety and effectiveness of the SurgiCase Guides. Testing verified that the accuracy and performance of the device is adequate to perform as intended. Additionally, the use of a scientific Stability Model ensures the most stable position on the patient's anatomy for accurate guiding of surgical instruments.

Clinical testing

Non-clinical testing was sufficient to demonstrate that the device's safety and effectiveness is substantially equivalent to the predicate device.

Other performance data

Retrospective analysis of clinical cases performed in Europe confirms the subject device's safety and effectiveness is substantially equivalent to the predicate device to use as intended based on surgeon evaluation of expected outcome.

These clinical cases are also described in the following paper:

Victor J, Premanathan A, Virtual 3D planning and patient specific guides for osteotomies around the knee: a feasibility and proof-of-concept study, BONE & JOINT JOURNAL 2013 .95B(11, suppl. A).p.153-158

Summary

All non clinical testing and other performance data indicate that the subject device is as safe, as effective, and performs as well as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 10, 2014

Materialise N.V. Mr. Oliver Clemens Technologielaan 15 Leuven, 3001 BE

Re: K132290

Trade/Device Name: Surgicase orthopaedics system, surgicase connect, surgicase guides Regulation Number: 21 CFR 888.3030 Regulation Name: Orthopaedic Surgical Planning And Instruments Guide Regulatory Class: Class II Product Code: PBF Dated: February 21, 2014 Received: February 24, 2014

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. 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801); please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

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 on last page.

510(k) Number (if known) K132290

Device Name

SurgiCase Orthopacdics system

Indications for Use (Describe)

The SurgiCase Orthopsedics system is intended to be used as a surgical instrument to essist in pre-operative planning and/or in guiding the marking of bone and or guide surgical instruments in non-joint replacing osteotomics for upper extremity orthopedie surgical procedures and osteotomics around the knee.

The system is to be used for adult patients.

SurgiCase Guides are intended for single use only.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

["\] : T\Lidning Son inst ( 101) : 41 1-6740

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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 Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.