The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Materialise TKA Guide System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing. Zimmer NexGen LPS-Flex fixed bearing. Zimmer NexGen LPS fixed bearing. Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona™ Trabecular Metal™, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Consensus Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR and Omni Apex PS total knee prostheses during total knee arthroplasty surgical procedures.

The Materialise TKA Guides are intended for single use only.

Device Description

Materialise TKA Guides are patient-specific medical devices that are designed to implant total knee prosthesis during total knee arthroplasty surgical procedures.

The Materialise TKA Guides must only be used in conjunction with the Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persond™ CR fixed bearing, Zimmer Persong™ PS fixed bearing, Zimmer Persona ™ Trabecular Metal ™, Vanguard® Complete Knee System, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Consensus Knee System, Lima Physica PS System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex PS total knee prostheses. Consult the prosthesis labeling and instructions for use for specific patient indications, contraindications, associated risks, information for use, warnings and precautions. Materialise TKA Guides is an instrument set containing a femur and/or tibia template(s).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Materialise TKA Guide System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it relies on a validation study to demonstrate "accuracy and performance...adequate to perform as intended" and "substantial equivalence" to a predicate device.

Performance Metric (Implicit)	Acceptance Criteria (Implicit)	Reported Device Performance
Accuracy of Plan Transfer	Adequate transfer of the pre-surgical plan to actual patient anatomy in a simulated environment, demonstrating substantial equivalence to the predicate device.	"The patient specific templates were subjected to a sawbone validation test in order to validate the use of the Materialise TKA Guide System and to demonstrate that the performance of the subject device is substantially equivalent to the predicate device (K150928) with respect to transferring a pre-surgical plan to actual patient anatomy in a simulated environment. Testing verified that the accuracy and performance of the system is adequate to perform as intended." Details of "adequate" are not quantified.
Functionality	The system can generate a pre-surgical plan, allow surgeon review/approval, design guides, and the guides can assist in positioning and aligning components intra-operatively.	The document describes the functioning of the device as generating a pre-surgical plan, allowing surgeon fine-tuning and approval, designing and manufacturing patient-specific guides, and the guides assisting in intra-operative positioning, alignment, and marking drill locations for total knee replacement components. The validation study implies this functionality was successfully demonstrated.
Compatibility	Compatibility with an established list of total knee arthroplasty implants, including additional ones for the subject device.	The device is compatible with a comprehensive list of Zimmer, Vanguard, Regenerex, Maxim, Ascent, AGC, Consensus, Lima Physica, and Omni Apex total knee prostheses.

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

Sample Size for Test Set: Not explicitly stated as a number of cases or subjects. The document refers to a "sawbone validation test" and "patient specific templates," implying a number of templates/sawbones were tested. However, the exact quantity is not provided.
Data Provenance: The study was a "sawbone validation test" performed in a "simulated environment." This indicates it was a laboratory-based, prospective test using cadaveric or synthetic bone models (sawbones). The country of origin of the data is not specified, but the applicant company is based in Belgium.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. However, the "functioning of the device" section states the pre-surgical plan is "used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan." This suggests involvement of qualified surgeons in establishing the intended surgical plan which the device is then validated against. Whether these "qualified surgeons" also established the ground truth measurements for the sawbones is not explicitly stated.

4. Adjudication Method for the Test Set

Not applicable/Not described. The study appears to be a technical validation of accuracy against a predefined surgical plan, rather than a clinical interpretation study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not described. The validation focused on the device's accuracy in transferring a pre-surgical plan using sawbones, not on improving human reader performance with or without AI assistance. The device is a surgical instrument/guide, not an AI diagnostic aid for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study Was Done

Yes, a standalone study of the device's performance (specifically the patient-specific templates in a simulated environment) was done. The "sawbone validation test" assessed the accuracy and performance of the Materialise TKA Guide System in transferring a pre-surgical plan to actual patient anatomy in a simulated environment, independent of a human surgeon's real-time decision-making beyond the initial plan approval.

7. The Type of Ground Truth Used

The ground truth used was based on the pre-surgical plan approved by a qualified surgeon. The sawbone validation test aimed to demonstrate that the physical guides accurately transferred this approved plan to the simulated bone anatomy.

8. The Sample Size for the Training Set

Not applicable. The Materialise TKA Guide System is a patient-specific surgical guide system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its design is based on engineering principles and CAD/CAM from patient imaging data, not a machine learning model trained on a large dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of a machine learning algorithm. The "ground truth" for the device's design would be the established anatomical landmarks and biomechanical principles of total knee arthroplasty, and the surgeon's approved pre-surgical plan generated using the Materialise TKA Planner software.

Summary

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

November 7, 2016

Materialise NV Oliver Clemens Regulatory Officer Technologielaan 15 Leuven, 3001 BE Belgium

Re: K162273 Trade/Device Name: Materialise TKA Guide System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, OIY, OOG, MBH Dated: August 10, 2016 Received: August 12, 2016

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 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. 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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic 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

510(k) Number (if known) K162273

Device Name Materialise TKA Guide System

Indications for Use (Describe)

The Materialise TKA Guides are intended for single use only.

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)	☒ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

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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	Wim Claassen
Contact title	Orthopedic Guide Portfolio Manager
Contact e-mail address	Wim.Claassen@materialise.be

Submission date

The date of the Traditional 510(k) submission is August 10, 2016

Submission information

Trade Name	Materialise TKA PlannerMaterialise TKA Guide
Common Name	Knee prosthesis
Classification Name	Knee joint patellofemorotibial polymer /metal /polymer semi-constrained cemented prosthesis
Primary product code	JWH (21 CFR 888.3560)
Subsequent product codes	OIY, OOG, MBH

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Predicate Devices

The predicate devices to which substantial equivalence is claimed:

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

Device Description

Materialise TKA Guides are patient-specific medical devices that are designed to implant total knee prosthesis during total knee arthroplasty surgical procedures.

The Materialise TKA Guides must only be used in conjunction with the Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persond™ CR fixed bearing, Zimmer Persong™ PS fixed bearing, Zimmer Persona ™ Trabecular Metal ™, Vanguard® Complete Knee System, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Consensus Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex PS total knee prostheses. Consult the prosthesis labeling and instructions for use for specific patient indications, contraindications, associated risks, information for use, warnings and precautions. Materialise TKA Guides is an instrument set containing a femur and/or tibia template(s).

Intended Use

The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking or bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Materialise TKA Guide System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona TM Trabecular Metal ™, Vanguard® Complete Knee System, Vanguard® SSK 360, Vanguard® SSK Revision Knee System, Regenerex® Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim® Complete Knee System, Ascent™ Total Knee System, AGC® Complete Knee system, Consensus Knee System, Lima Physica PS System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex PS total knee prostheses during total knee arthroplasty surgical procedures.

The Materialise TKA Guides are intended for single use only.

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Functioning of the Device

The Materialise TKA Guide System generates a pre-surgical plan based on MRI images using the Materialise TKA Planner. The software device then is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next, Materialise TKA Guides are designed and manufactured based on the approved presurgical plan. Materialise TKA Guides are patient specific templates which transfer the pre-operatively determined positioning of the chosen total knee replacement components to the patient intra-operatively, assisting the surgeon in positioning and aligning the actual total knee replacement components by guiding and marking drill locations.

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 predicate device is compatible with an established list of brands of total knee arthroplasty implants. The subject device is additionally compatible with Lima Physica PS System, Physica CR Knee System, and Physica KR Knee System and Omni Apex CR and Omni Apex PS knee prostheses.

Performance Data

Materialise TKA Guide System was validated though non-clinical tests to verify the system is adequate to perform as intended and to determine substantial equivalence. Previous testing, biocompatibility, sterility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate substantial equivalence with the predicate device. The patient specific templates were subjected to a sawbone validation test in order to validate the use of the Materialise TKA Guide System and to demonstrate that the performance of the subject device is substantially equivalent to the predicate device (K150928) with respect to transferring a pre-surgical plan to actual patient anatomy in a simulated environment. Testing verified that the accuracy and performance of the system is adequate to perform as intended.

Summary

The characteristics that determine the functionality and performance of the Materialise TKA Guide System are substantially equivalent to the device cleared under K150928. The non-clinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicate. The Moterialise TKA Guide System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (9000 and 13485) requirements.

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.