The TruMatch CMF Titanium 3D Printed Implant is a patient specific implant and is intended for bone fixation and reconstruction, restoration of bone defects and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton, midface and chin.

Device Description

The implants feature a mesh-like structure. The mesh-like structures are designed with the same elementary pattern. This pattern was designed to obtain implants with mechanical properties close to those of bone and to allow for osseointegration.

The TruMatch CMF Titanium 3D Printed Implant can be used in combination with TruMatch CMF Titanium 3D Printed Accessories (patient-specific guides), cleared as SurgiCase guides (K103136) and TruMatch CMF Titanium 3D Printed Implant System (K170272). The guides are intended to aid with implant positioning.

The TruMatch CMF Titanium 3D Printed Implant provides surgeons with a patient-specific implant solution for plastic and reconstructive surgery. The device is constructed based on the patient's CT imaging data.

The TruMatch CMF Titanium 3D Printed Implant is designed to fit the patient's anatomy and is not contoured manually by the surgeon. The TruMatch CMF Titanium 3D Printed Implant is designed and manufactured with integrated screw holes to fixate the bone using: MatrixMIDFACE (K050608), MatrixMANDIBLE (K063790, K121574), MatrixORTHOGNATHIC (K083388), MatrixNEURO screws (K123723, K042365), and Synthes Craniofacial Screw System (K050608).

The TruMatch CMF Titanium 3D Printed Implant contains the following applications:

Reconstruction applications: Orbital
Brand name: TruMatch CMF Ti 3D-Printed Implants
Material: Commercially pure titanium
Type of design: Patient Specific
Type of application: Implant thickness: 0.4-1.5mm
Patient specific associated instrument: Orbital guide

Reconstruction applications: Mandible, midface
Brand name: TruMatch CMF Ti 3D-Printed Implant
Material: Commercially pure titanium
Type of design: Patient Specific
Range of length: 10-294mm
Curvature: 0°-12°/mm length
Type of application: Range of shapes:
Midface reconstruction: Mesh-shaped, contoured to the patient's anatomy One/multi piece One/multi layered
Implant thickness: 0.8-10mm
Patient specific associated instrument: Midface guide
Mandibular reconstruction: Mesh-shaped, contoured to patient's anatomy Single/double strut Straight Curved/crescent Subcondylar Plated extensions One/multi layered Combinations of the above
Implant thickness: 1.2-10mm
Patient specific associated instrument: Mandibular guide

AI/ML Overview

This is a 510(k) summary for a medical device called the "TruMatch CMF Titanium 3D Printed Implant" (K173039). The document focuses on demonstrating that this new device is substantially equivalent to existing, legally marketed predicate devices.

Let's break down the information regarding acceptance criteria and the supporting study, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are primarily based on demonstrating performance equivalent to or non-inferior to predicate devices, rather than strict pre-defined numerical thresholds for a novel diagnostic accuracy claim. The performance data presented is focused on various engineering and biological tests.

Test Category	Acceptance Criteria (Implied / Stated Goal)	Reported Device Performance
Mechanical Testing (ASTM F382)	Equivalent static bending properties and non-inferior fatigue bending properties compared to reference devices.	The results indicate that the subject device has equivalent static bending properties and has non-inferior fatigue bending properties compared to the reference devices.
Sterilization Testing (ISO 17665-1, ISO 14161, ISO 11737-2)	Effective steam sterilization to a sterility assurance level (SAL) of 10^-6.	The provided sterilization instructions effectively steam sterilize the subject device to a SAL of 10^-6.
Environmental Conditioning & Simulated Shipping (ISTA 2A)	Packaging adequate to protect the device from damage during shipment.	The packaging specifications are found to be adequate to protect the device from damage during shipment.
Compatibility Testing	Compatibility with Synthes fixation systems.	The subject device is compatible with the Synthes fixation systems.
Biocompatibility Testing (ISO 10993-5, -10, -11, -17, -18)	No cytotoxic effect, compliance with irritation and sensitization requirements, negative systemic toxicity, no toxicological concern from leachable substances.	- Cytotoxicity: No cytotoxic effect. - Sensitization: In compliance with ISO 10993-10 guidelines. - Intra-cutaneous reactivity: In compliance with ISO 10993-10 guidelines. - Systemic toxicity: Test passed and considered negative. - Chemical characterization: As per report. - Leachable substances: No toxicological concern remains, further biological testing not justified.

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

The provided document describes testing for a physical implant, not an AI/ML device that would typically have a "test set" of data. Therefore, the concepts of "sample size used for the test set" and "data provenance (e.g., country of origin of the data, retrospective or prospective)" are not applicable in this context. The "test set" here refers to the physical devices (implants, packaging, materials) that were subjected to the various engineering and biological tests. The document does not specify the exact number of implants or material samples tested for each category (e.g., how many implants for mechanical testing).

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

This section is not applicable as the document describes a physical medical device (implant) and its performance through engineering and biological testing, not a diagnostic or AI/ML device requiring expert-established ground truth. The "ground truth" for these types of tests is generally defined by the standards themselves (e.g., ASTM F382, ISO 10993 series), which specify acceptable performance limits.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as points 2 and 3. Adjudication methods like 2+1 or 3+1 are used in scenarios where multiple human readers assess a case and their interpretations need to be reconciled, typically in AI/ML performance studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is not applicable as this document describes a physical medical implant, not an AI medical device.

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

A standalone performance study of an algorithm is not applicable as this document describes a physical medical implant, not an AI medical device.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed on the TruMatch CMF Titanium 3D Printed Implant is based on:

Established Industry Standards and Specifications: For mechanical properties (ASTM F382) and biocompatibility (ISO 10993 series), the acceptance criteria are defined by these internationally recognized standards.
Sterility Assurance Levels (SAL): For sterilization, the ground truth is a demonstrated SAL of 10^-6, which is a standard regulatory requirement.
Functional Compatibility: For compatibility with fixation systems, the ground truth is that the device works with the specified Synthes systems.

8. The Sample Size for the Training Set

This is not applicable as the document describes a physical medical implant, not an AI medical device that requires a "training set." The implants are patient-specific and manufactured based on individual patient CT scan data, but this is a manufacturing process, not a machine learning training process.

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

This is not applicable for the same reasons as point 8.

Summary

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July 10, 2018

Materialise NV Lina Ramirez Regulatory Officer Technologielaan 15 Leuven, 3001 BELGIUM

Re: K173039

Trade/Device Name: TruMatch CMF Titanium 3D Printed Implant Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: June 8, 2018 Received: June 11, 2018

Dear Lina Ramirez:

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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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 comprehensive regulatory information about medical devices and radiation-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.

Mary S. Runner -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173039

Device Name TruMatch CMF Titanium 3D Printed Implant

Indications for Use (Describe)

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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K173039- 510(k) SUMMARY

The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92

Submitter information

Company name	Materialise N.V.
Establishment registration number	3003998208
Street Address	Technologielaan 15
City	Leuven
Zip code	3001
Country	Belgium
Phone number	+32 16 74 49 56
Fax number	+32 16 39 66 00
Principal contact person	Lina Ramirez
Contact title	Regulatory Officer
Contact e-mail address	regulatory.affairs@materialise.be
Additional contact person	Mieke Janssen
Contact title	Senior Regulatory Officer
Contact e-mail address	mieke.janssen@materialise.be

Date of preparation

This summary was last updated on July 9, 2018.

Submission information

	TruMatch CMF Titanium 3D Printed Implant
Trade name(s)	TruMatch CMF Ti 3D-Printed Plates and TruMatch CMF Ti 3D-Printed Surgical Guides
	TruMatch CMF Ti 3D-Printed Implants.
Common or Usual name	Bone plate
Classification name	Bone plate
Product code (classification regulation)	JEY
Classification Panel	Dental
Device class	Class II (21 CFR 872.4760)

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Predicate device

The predicate device to which substantial equivalence is claimed to:

TruMatch CMF Titanium 3D Printed Implant System
Bone plate and screw
Trade or proprietary or model name	TruMatch CMF Titanium 3D Printed Implant System
510(k) number	K170272
Decision date	08/08/2017
Product code	JEY (21 CFR 872.4760)
Manufacturer	Materialise N.V.

Reference devices:

OsteoFab Patient Specific Facial Device - OPSFD
Bone plate and screw
Trade or proprietary or model name	OsteoFab patient Specific facial Device
510(k) number	K133809
Decision date	07/28/2014
Product code	KKY (21 CFR 878.3500)
Manufacturer	Oxford Performance Materials, Inc.

Synthes MatrixMANDIBLE Plate and Screw System
Bone plate and screw
Trade or proprietary or model name	Synthes MatrixMANDIBLE Plate and Screw System
510(k) number	K063790
Decision date	04/16/2007
Product code	JEY (21 CFR 872.4760)
Manufacturer	Synthes (USA)

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Synthes Craniofacial Plate and Screw System
Bone plate and screw
Trade or proprietary or model name	Synthes Craniofacial Plate and Screw System
510(k) number	K080331
Decision date	04/30/2008
Product code	JEY (21 CFR 872.4760)
Manufacturer	Synthes (USA)

Synthes Matrixorthognathis Fixation System
Bone plate and screw
Trade or proprietary or model name	Synthes Matrixorthognathis Fixation System
510(k) number	K083388
Decision date	03/12/2009
Product code	JEY (21 CFR 872.4760)
Manufacturer	Synthes (USA)

The Synthes (USA) Neuro Plate and Screw System
Bone plate and screw
Trade or proprietary or model name	The Synthes (USA) Neuro Plate and Screw System
510(k) number	K042365
Decision date	11/18/2004
Product code	JEY
Manufacturer	Synthes (USA)

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Synthes Patient Specific Cranial/Craniofacial Implant (PSCI)
Plate, Cranioplasty, preformed, non-alterable
Trade or proprietary or model name	Synthes Patient Specific Cranial/Craniofacial Implant (PSCI)
510(k) number	K053199
Decision date	12/14/2005
Product code	GXN (21 CRF) 882.5330
Manufacturer	Synthes (USA)

Device Information

Indications for use

Device Description

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The TruMatch CMF Titanium 3D Printed Implant contains the following applications:

Reconstruction applications: Orbital
Brand name	TruMatch CMF Ti 3D-Printed Implants
Material	Commercially pure titanium
Type of design	Patient Specific
Type of application	Implant thickness	Patient specific associated instrument
Orbital implants	0.4-1.5mm	Orbital guide

Reconstruction applications: Mandible, midface
Brand name	TruMatch CMF Ti 3D-Printed Implant
Material	Commercially pure titanium
Type of design	Patient Specific
Range of length	10-294mm
Curvature	0°-12°/mm length
Type of application	Range of shapes	Implant thickness	Patient specific associated instrument
Midface reconstruction	Mesh-shaped, contoured to the patient's anatomy One/multi piece One/multi layered	0.8-10mm	Midface guide
Mandibular reconstruction	Mesh-shaped, contoured to patient's anatomy Single/double strut Straight Curved/crescent Subcondylar Plated extensions One/multi layered Combinations of the above	1.2-10mm	Mandibular guide

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Comparison to the Predicate Device

Intended use:

	Subject device:TruMatch CMF 3D Printed Implants(K173039)	Predicate device:TruMatch CMF 3D Printed Implant System(K170272)
Product code	JEY	JEY
Classification	Class II	Class II
Intended Use	The TruMatch CMF Titanium 3D PrintedImplant is a patient specific Implant andis intended for bone fixation andreconstruction, restoration of bonedefects and intended to providecontinuity in regions where the bone ismissing and/or to augment the bone bymeans of an onlay device in themaxillofacial skeleton, midface and chin.	The TruMatch CMF 3D Printed ImplantSystem is intended for bone repositioning,fixation and reconstruction of themaxillofacial skeleton, midface, mandibleand chin in adolescents (greater than 12 to21 years of age) and adults.Specific indications for use:● Orthognathic surgery.● Reconstructive mandible andmaxillofacial surgery.● Mandible and maxillofacial traumasurgery.

Both the subject device and the predicate device have the same indications for use: bone fixation and reconstruction in the maxillofacial skeleton, midface and chin. Both devices are used in the same anatomical regions. The subject device and the reference device (OsteoFab Patient Specific Facial Device – OPSFD), are both intended for bone augmentation/enhancement.

	Subject device:	Predicate device:
	TruMatch CMF Titanium 3D Printed	3DTruMatch CMFTitaniumPrinted
	Implants	Implant System

	(K173039)	(K170272)
Product code	JEY	JEY
Classification	Class II	Class II
Technicalspecification	Bone plate	Bone plate
Fixation method	Synthes screw system	Synthes screw system
Material(s)	Commercially pure titanium	Commercially pure titanium
Manufacturingmethod	Additive manufacturing	Additive manufacturing
Providedsterile?	No	No
Sterilizationmethod	Moist heat	Moist heat
Devicethickness	0.4 mm – 10 mm	0.8 mm - 3.0 mm
Patient-specific	Yes. Devices are manufactured patient-	Yes. Devices are manufactured patient-
configuration?	specific, based on a CT scan of the	specific, based on a CT scan of the patient.
	patient.

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Both the subject and the predicate device are manufactured in commercially pure titanium. The subject device and the predicate device are fixed with screws.

Both the subject device and the predicate device are not provided sterile and have the same sterilization method, moist heat.

The subject device and the predicate device use an additive manufacturing technique to manufacture the implants. The subject device and the predicate are manufactured from commercially pure titanium in a mesh-like structure, and can be used with accessories (patientspecific guides).

The subject device and predicate device are made patient specific, manufactured from patient CT scan data.

The thickness range of the subject device falls into the thickness range of the predicate and the reference devices.

Performance data

The following non-clinical testing was conducted as a basis for the determination of substantial equivalence:

Test	Test method summary	Results
Mechanical testing	ASTM F382: StandardSpecification and Test Methodfor Metallic Bone Plates	The results of this test indicatethat the subject device hasequivalent static bendingproperties and has non-inferiorfatigue bending propertiescompared to the referencedevices.
Sterilization testing	Steam sterilization validationaccording to ISO 17665-1 andISO 14161, ISO11737-2:2009	The provided sterilizationinstructions effectively steamsterilize the subject device to aSAL of 10-6.
Environmental conditioningand simulated shippingtesting	According to ISTA 2A	The packaging specifications arefound to be adequate to protectthe device from damage duringshipment.
Compatibility testing	Combination of user needvalidation lab and engineeringrationale	The subject device is compatiblewith the Synthes fixationsystems.

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Biocompatibility test overview
Test/assessment description	Test report conclusion
• Cytotoxicity:ISO 10993-5: Tests for in-vitro cytotoxicity -L929 Neutral red uptake Cytotoxicity	- no cytotoxic effect
• Sensitization:ISO 10993-10: Tests for irritation anddelayed-type hypersensitivity - KligmanMaximization test	- in compliance with requirements of the ISO10993-10 guidelines
• Intra-cutaneous reactivity:ISO 10993-10: Tests for irritation anddelayed-type hypersensitivity - Intra-cutaneous Injection Test	- in compliance with requirements of the ISO10993-10 guidelines
• Systemic toxicity:ISO 10993-11: Tests for systemic toxicity -Systemic injection test	- test passed and is considered negative basedon standards set by ISO 10993-11
• Chemical characterization:ISO10993-18: Biological Evaluation ofMedical Devices - Part 18: ChemicalCharacterization of Materials (2005)	- chemical characterization as per report
• Assessment of allowable limits for leachablesubstances:ISO 10993-17 (2009) "Biological evaluationof medical devices — Part 17: Establishmentof allowable limits for leachable substances"	- no toxicological concern remains- further biological testing are considered notjustified

The following nonclinical tests were conducted on the TruMatch CMF Titanium 3D Printed Implant as a basis for the determination of substantial equivalence: Performance testing of the TruMatch CMF Titanium 3D Printed implants and accessories, including

Mechanical performance of the subject device compared to the predicate and reference devices
Compatibility testing
. Biocompatibility testing
Sterilization testing
. Environmental conditioning and simulated shipping testing

Conclusion

Non-clinical tests demonstrate that the TruMatch CMF Titanium 3D Printed Implant is substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.