The Materialise TKA Guides are 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 Guides 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® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, 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, Lima Physica PS System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Guides are intended for single use only.

• Cut-Through Guides

The Materialise TKA Guides must be used in conjunction with the 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.

• Models

The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components.

The Materialise TKA Models must be used in conjunction 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® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, 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, Lima Physica PS System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS , Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Models are intended for single use only.

Software

The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models.

Device Description

The Materialise TKA guide system is a medical device designed to implant total knee prosthesis components during a total knee arthroplasty surgical procedure. This can be done by generating a pre-surgical knee plan and by manufacturing a patient-specific knee guide and models to transfer the knee plan to surgery.

The subject device is a system that consists of the following two functional components:

l A software component branded as SurgiCase Knee Planner. This software is a planning tool used to generate a pre-surgical TKA plan for a specific patient.
Hardware components branded as Materialise TKA Guides and Models: which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Materialise TKA Guides and Models is an instrument set containing a femur and/or tibia guide(s) and bone models (optional). Both femoral and tibial guides are designed and manufactured to fit the anatomy of a specific patient. If the surgeon requests it, a bone model of the femur and/or tibia are delivered with the Materialise TKA Guides. The Materialise TKA Guides and Models assist in the intra-operative positioning of total knee replacement components. The guides assist in guiding the marking of bone before cutting and cutting of the bone. The models serve as a visual reference for the surgeon in the operating room. The Materialise TKA Guides and Models must only be used within the intended use of the compatible components (510(k) cleared, legally marketed prosthesis).

AI/ML Overview

The provided text from the FDA 510(k) summary (K221337) describes the Materialise TKA Guide System, but does not include detailed acceptance criteria or a study proving that the device meets specific performance criteria with quantitative results.

Instead, it relies on substantiating equivalency to a predicate device (K173445) and primarily focuses on verification and validation activities for the software, and re-evaluation/re-testing of hardware characteristics like biocompatibility, cleaning, sterilization, and packaging due to specific updates or extended specifications. It states that "Previous testing for 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."

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor detailed information about specific studies to prove device performance against those criteria, as this information is not present in the provided document.

However, I can extract information about the studies and verification activities that were performed, based on the provided text, and address the points that can be answered:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is NOT PRESENT in the provided document. The document does not specify quantitative acceptance criteria for the accuracy or performance of the TKA Guide System (e.g., specific angular deviation tolerances, linear accuracies, etc.) nor does it report specific performance metrics from a study that demonstrate the device meets such criteria. It generally states that "Testing verified that the accuracy and performance of the system is adequate to perform as intended" and that "the subject device is as safe, as effective, and performs as well as the predicate device."

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

Test Set Sample Size: Not explicitly stated for performance testing related to accuracy. The document mentions "All samples passed the cleaning test" and "All samples passed the sterilization test," but the number of samples is not specified.
Data Provenance: Not specified for any performance testing. It is not clear if any in vivo or ex vivo testing of the device's accuracy was performed as part of this submission, or if it relies entirely on the predicate's performance claims. The document mentions "previous simulated surgeries using rapid prototyped bone models and previous cadaver testing are considered applicable to the subject device," implying that these were done for the predicate, not necessarily for the current submission.

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

This information is NOT PRESENT in the provided document. The document does not describe studies involving experts establishing ground truth for performance evaluation of the device's accuracy.

4. Adjudication Method for the Test Set:

This information is NOT PRESENT in the provided document. No adjudication method is mentioned as there's no description of a study involving expert assessment of performance.

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

No MRMC comparative effectiveness study is mentioned in the provided document. The document focuses on regulatory clearance based on substantial equivalence, not comparative effectiveness studies with human readers assisting with AI vs. without AI. The device is a planning software and physical guides, not an AI diagnostic tool involving human readers.

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

A "standalone" software verification and validation was performed. The document states, "Software verification and validation were performed, and documentation was provided following the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.' This includes verification against defined requirements, and validation against user needs." However, specific performance metrics from this standalone validation are not reported. The "human-in-the-loop" aspect for this device is the surgeon using the planning software and then using the physical guides in surgery. The software part itself is a planning tool, and its "standalone" performance would likely refer to its accuracy in generating measurements or plans, which is generally covered by its verification and validation.

7. Type of Ground Truth Used:

For the software verification and validation, the ground truth would typically be established based on defined requirements and user needs (as stated in the document). For hardware re-evaluations:
- Biocompatibility: ISO 10993-1:2018 standards (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity).
- Cleaning: "extended cleaning cycle specifications, including testing of both manual and automated cleaning cycle with both enzymatic and alkaline detergent on a new worst-case design." Ground truth would be cleanliness metrics, though not specified.
- Sterilization: ISO 17665-1:2006 "overkill method." Ground truth would be sterility assurance level.
- Packaging: ISO 11607-1:2019, ISTA 3A:2018, ASTM D4169-16. Ground truth would be packaging integrity after simulated distribution.

8. Sample Size for the Training Set:

The document does NOT mention a training set in the context of machine learning or AI. The software described is a "planning tool" and does not appear to be an AI/ML algorithm that would undergo a distinct training phase.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned.

Summary

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July 5, 2022

Materialise NV Jenny Jones Global Ouality and Regulatory Manager Technologielaan 15 Leuven, 3001 Belgium

Re: K221337

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, OIY, OOG, MBH Dated: May 6, 2022 Received: May 9, 2022

Dear Jenny Jones:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ting Song, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221337

Device Name Materialise TKA Guide System

Indications for Use (Describe)

Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components.

Hardware

· 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.

• Models

The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components.

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Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Models are intended for single use only.

Software

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)

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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 66 11
Fax number	+32 16 39 66 06
Principal contact person	Jenny Jones
Phone number	734-259-7017
Contact title	Global Quality Regulatory Manager
Contact e-mail address	Regulatory.Affairs@materialise.be
Additional contact person	Ilke Vanhaelen
Contact title	Device Development Engineer
Contact e-mail address	ilke.vanhaelen@materialise.be

Submission date

The date of the Traditional 510(k) submission is May 06, 2022.

Submission information

Trade Name	Materialise TKA Guide System
Common Name	Total knee replacement system with 3D planning software andpatient specific instrumentation
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:

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Trade or proprietary or model name	Materialise TKA Guide System
510(k) number	K173445
Decision date	February 2, 2018
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	Materialise PKA Guide System
510(k) number	K202207
Decision date	October 02, 2020
Classification product code	HSX (21CFR888.3520)
Manufacturer	Materialise N.V.

Device Description

The subject device is a system that consists of the following two functional components:

l A software component branded as SurgiCase Knee Planner. This software is a planning tool used to generate a pre-surgical TKA plan for a specific patient.
Hardware components branded as Materialise TKA Guides and Models: which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Materialise TKA Guides and Models is an instrument set containing a femur and/or tibia guide(s) and bone models (optional). Both femoral and tibial guides are designed and manufactured to fit the anatomy of a specific patient. If the surgeon requests it, a bone model of the femur and/or tibia are delivered with the Materialise TKA Guides. The Materialise TKA Guides and Models assist in the intra-operative positioning of total knee replacement components. The guides assist in guiding the marking of bone before cutting and cutting of the bone. The models serve as a visual reference for the surgeon in the operating room. The Materialise TKA Guides and Models must only be used within the intended use of the compatible components (510(k) cleared, legally marketed prosthesis).

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Indications for use

Note: indications for use differ from the predicate device because the compatible knee systems are the indications for use statement clarifies use of the models and software.

Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components.

Hardware

Pin Placement Guides
The Materialise TKA Guides are 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 Guides 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® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, 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, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex PS, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Guides are intended for single use only.

Cut-Through Guides
The Materialise TKA Guides are 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 and cutting of the bone.

The Materialise TKA Guides must be used in conjunction with the 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.

Models
The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra-operative positioning of Total Knee Replacement components.

The Materialise TKA Models must be used in conjunction 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® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, 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, Lima Physica PS System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex PS , Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

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The Materialise TKA Models are intended for single use only.

Software

The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise Knee Guides and Models.

Functioning of the Device

The Materialise TKA Guide System generates a pre-surgical plan based on MRI or CT images using the SurgiCase Knee Planner. The SurgiCase Knee Planner then is used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next, Materialise TKA Guides and Models are optional) are designed and manufactured based on the approved pre-surgical plan. Moterialise 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 the actual total knee replacement components by guiding the marking of bone before cutting and to guide cutting of the bone. The patient-specific models serve as a visual reference for the surgeon in the operating room.

Technological Characteristics

A detailed comparison shows the Materialise TKA Guide System is substantially equivalent in intended use, design, functionality, operating principles, materials, performance characteristics and the same fundamental scientific technology to the predicate device.

The Materialise TKA Guide System has an equivalent intended use and the same fundamental scientific technology as the predicate device. The subject device's software is intended for simulation and planning of pre-operational intervention, and for positioning knee components, i.e., tibia and femur components (same as the predicate device and reference device). The subject device's hardware is intended for positioning knee components intra-operatively and in guiding the marking of bone before cutting of the bone (same as the predicate device).

Software

The subject software device employs similar fundamental technologies as the predicate software device. Technological similarities include:

Device functionality: The planning functionality, visualization options and planning features are the same for the knee planning of the subject device as for the predicate device.
Software technology: The subject device has the same code base as the predicate device and uses exact the same methods for design and verification as the predicate device.

Following technological differences exist between the subject device software and the predicate device software.

The main difference between the subject device and previously cleared predicate device K173445 is the addition of Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and

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Ortho Development BKS TriMax PS implants and instruments in the software component of the subject device for the surgeon to select during the planning stage.

The subject software technology differences have been demonstrated to not affect safety or effectiveness or raise new issues of safety or effectiveness compared to the predicate device.

Hardware

The subject hardware device is substantially equivalent in intended use, design, functionality, operating principles, raw materials, and performance characteristics to the predicate device K173445.

The main difference between the subject device and previously cleared predicate device K173445 includes: the addition of Materialise TKA Guides and Models that are compatible with the Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS implants and instruments. This resulted in the update of non-critical features of the Materialise TKA guides and models that will be used for this system.

Performance Data (non-clinical)

Hardware

Previous testing for 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. The stability of the device placement, surgical technique, intended use and functional elements of the subject device are similar as that of the predicate device, and therefore previous simulated surgeries using rapid prototyped bone models and previous cadaver testing are considered applicable to the subject device.

Although no additional tests in comparison with the predicate device testing were required to support substantial equivalence, new biocompatibility, end-user cleaning, sterilization, and packaging testing have been done for other reasons as explained below.

-Biocompatibility re-evaluation according to ISO 10993-1:2018 was done. The subject device was shown to be non-cytotoxic, non-sensitizing, non-irritant, non-systematically toxic (acute) and nonpyrogenic.
-End-user cleaning re-evaluation was done on extended cleaning cycle specifications, including testing of both manual and automated cleaning cycle with both enzymatic and alkaline detergent on a new worst-case design. All samples passed the cleaning test, validating the updated cleaning parameters.
। Sterilization re-evaluation using an overkill method total cycle in accordance with ISO 17665-1:2006 on a new worst-case design. All samples passed the sterilization test, validating the applied sterilization parameters for the subject device.
-Packaging testing for the added packaging configuration according to ISO 11607-1:2019 according to ISTA 3A:2018 and simulated distribution in accordance with ASTM D4169-16. Samples passed the packaging testing, demonstrating that new packaging configuration meets approved requirements, allowing to effectively and safely ship the subject device, based on the validation performed on the specifications for the packaging applied.

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Software

Software verification and validation were performed, and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This includes verification against defined requirements, and validation against user needs.

Summary

The non-clinical performance testing indicates that the subject device is as safe, as effective, and performs as well as the predicate device. Therefore, it can be concluded that the Materialise TKA System is substantial equivalent to the predicate device.

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.