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 of 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™ 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, and AGC® Complete Knee system, and Consensus 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 the following knee prostheses:

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, and AGC® Complete Knee system, and Consensus Knee System.

The Materialise TKA Guides must only be used in conjunction with the implants listed above. Consult the prosthesis labeling and instructions for use for specific patient indications, 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 describes a 510(k) premarket notification for the Materialise TKA Guide System. While it states that "non-clinical tests using saw bones" and "Cadaver testing" were performed to verify the system's adequacy and demonstrate equivalent product performance, it does not provide specific quantitative acceptance criteria or detailed results of a study designed to prove the device meets those criteria.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred and what is missing:

1. Table of acceptance criteria and reported device performance:

The document mentions "accuracy and performance of the system is adequate to perform as intended" and "demonstrated equivalent product performance as the existing predicate devices," but it does not specify what those performance metrics or their acceptance criteria are.

Acceptance Criteria	Reported Device Performance
(Not specified in the document)	"accuracy and performance of the system is adequate to perform as intended"
(Not specified in the document)	"equivalent product performance as the existing predicate devices (K102795 and K133162)"

2. Sample sized used for the test set and the data provenance:

Sample Size: Not specified for "saw bones" or "cadaver testing."
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were non-clinical, so human patient data provenance is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The term "ground truth" as typically used for AI/ML validation (e.g., expert consensus) is not directly applicable to the non-clinical hardware testing described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study is not mentioned. The studies described are non-clinical (saw bones, cadaver) rather than clinical studies involving human readers or decision-making.

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

The document mentions "non-clinical tests using saw bones" and "Cadaver testing." These tests evaluate the physical guide's accuracy in transferring the surgical plan (generated by the software) to the bone. This represents a form of standalone performance evaluation for the physical guide's output accuracy based on the plan. However, the performance of the software algorithm itself in producing the initial plan is not detailed as a separate standalone study with specific metrics. The software is used "pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan," implying human-in-the-loop for the planning phase.

7. The type of ground truth used:

For the "saw bones" and "cadaver testing," the ground truth would likely be based on physical measurements of the actual cut/drill locations relative to the intended surgical plan. This is a form of physical measurement/dimensional accuracy rather than expert consensus, pathology, or outcomes data typically used for diagnostic or predictive AI.

8. The sample size for the training set:

The document describes the Materialise TKA Guide System, which involves software for pre-surgical planning and 3D printed surgical guides. It doesn't explicitly mention an AI/ML component with a separate "training set" in the context of a typical AI/ML development pipeline. The "Materialise TKA Planner" is software device, but its development methodology (e.g., machine learning training) is not detailed.

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

Not applicable, as a discrete training set and its ground truth establishment are not described for an AI/ML model.

Summary

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

August 10, 2015

Materialise N.V. Laurel Berzanskis Regulatory Affairs Officer Technologielann 15 3001 Leuven Belgium

Re: K150928

Trade/Device Name: Materialise TKA Guide System (Materialise TKA Planner, Materialise TKA Guides) 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: July 6, 2015 Received: July 10, 2014

Dear Laurel Berzanskis:

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

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Page 2 - Laurel Berzanskis

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

If vou 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" (21CFR 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,

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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Indications for Use

510(k) Number (if known): K150928

Device Name: Materialise TKA Guide System (Materialise TKA Planner, Materialise TKA Guides)

Indications for Use:

The Materialise TKA Guides are intended for single use only.

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

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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 74 45 37
Fax number	+32 16 39 66 06
Principal Contact person	Laurel Berzanskis
Contact title	Regulatory Affairs Officer
Contact e-mail address	Regulatory.Affairs@materialise.be
Additional contact person	Wim Claassen
Contact title	Product Manager
Contact e-mail address	Wim.Claassen@materialise.be

Submission date

The date of the Traditional 510(k) submission is April 3, 2015.

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

Predicate Devices

The primary predicate devices to which substantial equivalence is claimed:

Trade or proprietary or model name	Zimmer Patient Specific Instruments System 5.4
510(k) number	K133162
Decision date	February 25th, 2014

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Classification product code	JWH (21 CFR 888.3560)
Subsequent product codes	MBH, OIY, OOG
Manufacturer	Materialise N.V.

The secondary predicate device to which substantial equivalence is claimed:

Trade or proprietary or model name	Signature Personalized Patient Care System (SignaturePlanner; Signature guides)
510(k) number	K102795
Decision date	February 2nd, 2011
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 the following knee prostheses:

Intended Use

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,

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Maxim® Complete Knee System, Ascent™ Total Knee System, and AGC® Complete Knee system, and Consensus Knee System prostheses families only.

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 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 pre-surgical plan. Materialise TKA Guides are patient specific templates which transfer the preoperatively determined positioning of the chosen total knee replacement components to the patient intraoperatively, assisting the surgeon in positioning 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 primary predicate and secondary predicate devices, however offers a web based software application rather than a desktop application, and extends the compatible implant families to Consensus implants cleared under K945589, K932837, K143725, K110950, K102927, K001456, K983004, K962215, and K954818.

Performance Data

Materialise TKA Guide System was validated though non-clinical tests using saw bones to verify the system is adequate to perform as intended and to determine substantial equivalence. Previous testing for biocompatibility, sterility, cleaning, debris, dimensional stability and packaging are applicable to the subject device and demonstrate substantial equivalence with the predicate device. Testing verified that the accuracy and performance of the system is adequate to perform as intended. Cadaver testing validated the use of the subject device for use in total knee replacement and demonstrated equivalent product performance as the existing predicate devices (K102795 and K133162).

Summary

The characteristics that determine the functionality and performance of the Materialise TKA Guide System are substantially equivalent to the devices cleared under K133162 and K102795. The non-clinical testing indicates that the subject device is as safe, as effective, and performs as well as the predicates. 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.