The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the intra-operative positioning of total knee replacement components and in guiding the marking of bone before cutting.

The Materialise TKA Guide System must 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 Persona™ CR fixed bearing, Zimmer Persona™ 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, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex PS prostheses families only.

The Materialise TKA Guides are intended for single use only.

Cut-Through Guides

The Materialise TKA Guide System is intended to be used as a surgical instrument to assist in the intra-operative positioning of total knee replacements and in guiding the marking of bone before cutting of the bone.

The Materialise TKA Guide System must be used in conjunction with 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 and AGC™ Complete Knee system prostheses families only

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 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).

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and a study that quantitatively proves the device meets those criteria. It primarily focuses on the device's substantial equivalence to predicate devices based on non-clinical tests and overall performance.

However, based on the information available, here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly list quantitative acceptance criteria for the device's performance. It generally states that "the accuracy and performance of the system is adequate to perform as intended." The "Reported Device Performance" section below is an interpretation of the general claims made.

Acceptance Criteria Category	Specific Acceptance Criteria (as implied/inferred)	Reported Device Performance (as stated in the document)
Intended Use Fulfillment	Device successfully assists in intra-operative positioning and guiding bone marking/cutting for TKA.	The device is "adequate to perform as intended" for assisting in intra-operative positioning of total knee replacement components and guiding marking/cutting of bone.
Accuracy and Performance	(Specific quantifiable accuracy metrics such as deviation from planned cuts, angular alignment errors, etc., are not provided.)	"The accuracy and performance of the system is adequate to perform as intended."
Biocompatibility	Device materials are biocompatible for single-use surgical instruments.	"Previous testing for biocompatibility... are applicable to the subject device and demonstrate substantial equivalence with the predicate devices."
Sterility	Device maintains sterility until use.	"Previous testing for... sterility... are applicable to the subject device and demonstrate substantial equivalence with the predicate devices."
Debris	Device does not generate unacceptable levels of debris.	"Previous testing for... debris... are applicable to the subject device and demonstrate substantial equivalence with the predicate devices."
Dimensional Stability	Device maintains its intended dimensions and shape during use.	"Previous testing for... dimensional stability are applicable to the subject device and demonstrate substantial equivalence with the predicate devices."
Packaging Integrity	Packaging protects the device and maintains sterility.	"An updated packaging test is performed." (No specific results are given, only that it was performed).
Manufacturing Quality	Device manufactured under established quality systems.	"The Materialise TKA Guide System will be manufactured in compliance with FDA (CFR 820 & Part 11) and ISO quality system (9000 and 13485) requirements."

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

The document states, "Previous testing that the accuracy and performance of the system is adequate to perform as intended is applicable to the subject device." However, it does not provide information on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). It refers to "previous testing" which implies data from predicate devices or earlier iterations, but no specifics are given for this submission.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used or their qualifications for establishing ground truth within any performance study. The device's function involves a "qualified surgeon" approving a pre-surgical plan, which inherently involves expert input, but this is part of the clinical use rather than a study's ground truth establishment.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for a test set.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being conducted or its results (effect size of human readers with/without AI assistance). The device is a surgical guide system, not an interpretive AI tool for diagnostic images, thus an MRMC study in the typical sense (e.g., for radiology AI) would not likely be applicable or reported here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device description emphasizes that the "Materialise TKA Guide System generates a pre-surgical plan... The software device then is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan." This indicates a human-in-the-loop workflow.

The document does not explicitly describe a standalone performance study (algorithm only, without human interaction) for the device. The system's design inherently involves surgeon approval of the plan before guide manufacturing.

7. Type of Ground Truth Used

The "ground truth" for this type of device, a surgical planning and guiding system, would typically relate to the accuracy of implementing the surgeon-approved pre-surgical plan relative to the actual bone cuts and component placement. However, the document does not explicitly state the type of ground truth used for verifying the system's "accuracy and performance." Given the nature of TKA guides, it would likely involve:

Imaging-based comparisons: Post-operative CT or X-rays compared against the pre-operative plan to assess component alignment and cut accuracy.
Intra-operative measurements: Direct measurement of pin hole locations or cut depths relative to the surgical plan.
Expert Consensus/Surgeon Approval: The 'ground truth' of the plan itself is established by the surgeon's approval.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. The Materialise TKA Guide System is described as generating a pre-surgical plan based on MRI or CT images, and then designing guides. This suggests an engineering/design process rather than a machine learning model that requires a training set in the conventional sense. If its "planning" component uses algorithms, no training data for such algorithms is mentioned.

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

Since no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.

Summary

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February 2, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K173445

Trade/Device Name: Materialise TKA Guide System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH, OOG, OIY, MBH Dated: November 6, 2017 Received: November 6, 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 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);

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Page 2 - Oliver Clemens

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173445

Device Name Materialise TKA Guide System

Indications for Use (Describe) Pin Placement Guides

The Materialise TKA Guide System must 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 Persona™ CR fixed bearing, Zimmer Persona™ PS fixed bearing, Zimmer Persona™ 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 prostheses families only.

The Materialise TKA Guides are intended for single use only.

Cut-Through Guides

The Materialise TKA Guides are intended for single use only.

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.

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

Submission date

The date of the Traditional 510(k) submission is October 31, 2017

Submission information

Trade Name	Materialise TKA Guide System
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

Predicate Devices

The predicate devices to which substantial equivalence is claimed:

Trade or proprietary or model name	Materialise TKA Guide System
------------------------------------	------------------------------

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510(k) number	K162273
Decision date	November 7, 2016
Classification product code	JWH (21 CFR 888.3560)
Subsequent product codes	MBH, OIY, OOG
Manufacturer	Materialise N.V.

Trade or proprietary or model name	Signature Personalized Patient Care System
510(k) number	K110415
Decision date	May 16, 2011
Classification product code	HRY (21 CFR 888.3530)
Subsequent product codes	JWH, MBH, OIY, OOG
Manufacturer	Materialise N.V.

Trade or proprietary or model name	Zimmer Patient Specific Instruments System
510(k) number	K140027
Decision date	May 22, 2014
Classification product code	JWH (21 CFR 888.3560)
Subsequent product codes	MBH, OIY, OOG
Manufacturer	Materialise N.V.

The reference devices used to support a determination of substantial equivalence:

Trade or proprietary or model name	Kuvia3D
510(k) number	K161559
Decision date	June 23rd, 2016
Classification product code	LLZ (21 CFR 892.2050)
Manufacturer	4QIMAGING, LLC DBA QMETRICS

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Device Description

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

Intended Use

Pin Placement Guides

The Materialise TKA Guides are intended for single use only.

Cut-Through Guides

The Materialise TKA Guides are intended for single use only.

Functioning of the Device

The Materialise TKA Guide System generates a pre-surgical plan based on MRI or CT images using the Materialise TKA Planner. The software device then is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve

Materialise N.V.

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510(k) Summary

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 the marking of bone before cutting and to guide cutting of the bone.

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.

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 for biocompatibility, sterility, debris, dimensional stability are applicable to the subject device and demonstrate substantial equivalence with the predicate devices. An updated packaging test is performed. Previous testing that the accuracy and performance of the system is adequate to perform as intended is applicable to the subject device.

Summary

The characteristics that determine the functionality and performance of the Materialise TKA Guide System are substantially equivalent to the device cleared under K162273, K110415 and K140027. The nonclinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicate. The Materialise 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.