The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in adolescents (greater than 12 to 21 years of age) and adults.

Device Description

The MedCAD AccuPlate® 3DTi Patient-Specific Plating System is a metal bone plate used in conjunction with commercially available, non-locking metal bone screws for the fixation to bone in orbital, midface / maxillofacial, and non-continuity mandibular operations. The design and dimensions of each plate within the envelope specification is based upon the patient's anatomical data (CT scan, CBCT scan, or MRI), and the intended anatomy to be fixated as determined from input provided by the surgeon. The subject device is not intended to be bent or modified in surgery. If for any reason the surgeon chooses not to use the subject device in surgery, they may use any of the commercially available plates to complete the surgery. The subject device is additively manufactured from Ti-6AL-4V Extra Low Interstitial (ELI) titanium alloy, provided non-sterile, must be sterilized prior to use, and is intended for single use only. Plates are fastened to bone using commercially available non-locking bone screws with diameters ranging from 1.5mm to 2.7mm and lengths ranging from 3.5mm to 22mm.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the MedCAD® AccuPlate® 3DTi Patient-Specific Plating System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter mentions the following non-clinical performance tests. The acceptance criteria are implied to be "equivalent" to identified reference devices.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Meet ISO 10993-1, -5, and FDA guidance.	Results "adequately address biocompatibility for the plates and their intended use."
Sterilization Validation: Achieve a Sterility Assurance Level (SAL) of 10⁻⁶ per ISO 17665-1, -2, and FDA guidance.	"All test method acceptance criteria were met."
Static and Dynamic Bending (per ASTM F382): Equivalent bending strength and fatigue life to reference device K953385.	"The subject device was shown to have equivalent bending strength and fatigue life as the reference device (K953385)."
Axial Screw Pushout (per ASTM F543): Equivalent axial screw pushout strength at the plate/screw interface to reference device K953385.	"The subject device plate / screw interface was shown to have equivalent axial screw pushout strength as the reference device (K953385)."
Fit and Form Validation: Produce devices that align with the approved surgical plan.	"The subject device patient specific design process was shown to produce devices that aligned with the approved surgical plan."

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

The document does not explicitly state the sample sizes (number of devices or tests) for the non-clinical performance tests (bending, pushout, fit and form validation). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective, as these are non-clinical (mechanical and material) performance tests rather than clinical studies with patient data.

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

This information is not explicitly provided in the document. For non-clinical performance tests, "ground truth" is typically established by engineering standards and validated testing procedures, not by human experts in the same way as clinical image interpretation. The "Fit and Form Validation" mentions alignment with an "approved surgical plan," which would involve surgical expertise in its creation, but the number and qualifications of individuals involved in approving these plans or assessing the fit are not detailed.

4. Adjudication Method for the Test Set

Not applicable for these types of non-clinical, objective performance tests. Adjudication methods like 2+1 or 3+1 are typically used for subjective clinical interpretations by multiple readers (e.g., radiologists) in diagnostic accuracy 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

No such study was mentioned. The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is a patient-specific surgical implant, not an AI-assisted diagnostic tool.

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

This concept is not directly applicable. The device itself is an implant. However, the "patient specific design process" for creating the implant is an "algorithm only" type of process in that it uses patient anatomical data to generate the device design. The "Fit and Form Validation" likely assessed the output of this design process against the intended surgical plan. The document states that the design process "was shown to produce devices that aligned with the approved surgical plan," indicating successful standalone performance of the design software.

7. The Type of Ground Truth Used

Biocompatibility: Established by adherence to ISO 10993 standards and FDA guidance.
Sterilization Validation: Established by adherence to ISO 17665 standards and FDA guidance, with a specific SAL target.
Static and Dynamic Bending: Established by ASTM F382 standard, with comparison to a reference device's known performance.
Axial Screw Pushout: Established by ASTM F543 standard, with comparison to a reference device's known performance.
Fit and Form Validation: Established by alignment with an "approved surgical plan." This likely involves a comparison of the 3D-printed plate geometry with the virtual surgical plan derived from patient imaging data, which can be considered "design ground truth."

8. The Sample Size for the Training Set

The document does not describe the development or training of an AI algorithm in the traditional sense, so there is no mention of a training set sample size. The "patient-specific design software" is mentioned as being the same as a reference device (K192282), implying it's a previously validated system rather than a newly trained AI model.

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

As no training set for an AI algorithm is described, this information is not applicable.

Summary

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9/26/23

MedCAD % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickorv Flat Highway Suite 120 Woodstock, Georgia 30188

Re: K230398

Trade/Device Name: MedCAD® AccuPlate® 3DTi Patient-Specific Plating System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: August 28, 2023 Received: August 28, 2023

Dear Justin Gracyalny:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.

Sherrill L'athrop Blitzer

for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices

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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) K230398

Device Name

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System

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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K230398 510(k) SUMMARY:

Date Prepared	September 26, 2023
Sponsor Contact	MedCAD501 S 2nd Ave, Suite A-1000Dallas, TX 75226(214) 453-8864
510(k) Contact(s)	Secure BioMed EvaluationsJustin Gracyalny, MSELinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681Regulatory@SecureBME.com
Trade Name	MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
Code –Classification	Classification Name: Bone Plate (21 CFR 872.4760)Regulatory Class: IIProduct Code: JEY
PrimaryPredicate	K191028 KLS Martin Individual Patient Solutions
ReferenceDevices	K953385 Walter Lorenz Surgical, Inc. Lorenz SystemK210731 KLS Martin Individual Patient SolutionsK203282 Industrias Medicas Sampedro S.A.S. TECHFIT Patient-SpecificMaxillofacial SystemK170272 Materialize N.V. TruMatch CMF Titanium 3D Printed ImplantSystemK192282 MedCAD® AccuPlan® System
DeviceDescription	The MedCAD AccuPlate® 3DTi Patient-Specific Plating System is a metalbone plate used in conjunction with commercially available, non-lockingmetal bone screws for the fixation to bone in orbital, midface /maxillofacial, and non-continuity mandibular operations. The design anddimensions of each plate within the envelope specification is based uponthe patient's anatomical data (CT scan, CBCT scan, or MRI), and theintended anatomy to be fixated as determined from input provided by thesurgeon. The subject device is not intended to be bent or modified insurgery. If for any reason the surgeon chooses not to use the subject devicein surgery, they may use any of the commercially available plates tocomplete the surgery. The subject device is additively manufactured fromTi-6AL-4V Extra Low Interstitial (ELI) titanium alloy, provided non-sterile, must be sterilized prior to use, and is intended for single use only.Plates are fastened to bone using commercially available non-locking bone
Indications forUse Statement	The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System isintended for use in the stabilization, fixation, and reconstruction of themaxillofacial / midface and mandibular skeletal regions in adolescents(greater than 12 to 21 years of age) and adults.

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System

from 3.5mm to 22mm.

screws with diameters ranging from 1.5mm to 2.7mm and lengths ranging

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Comparison of Technological Characteristics

The MedCAD AccuPlate® 3DTi Patient-Specific Plating System is substantially equivalent to and are as safe and effective as its predicate device (K191028 KLS Martin Individual Patient Solutions). Table 1 compares the subject, predicate, and reference devices.

Similarities to Predicate

The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System has the same intended use and similar technological characteristics as the identified predicate device. The system employs similar fundamental technologies as the identified predicate / reference devices. The principles of operation and technological characteristics are either identical or substantially equivalent to the predicate / reference devices. The system has similar technological characteristics including:

The subject device and the predicate / reference devices have hole features to accommodate ● commercially available non-locking fixation screws.
. The subject device uses the same patient specific design software and process flow as the reference device (K192282).
. The subject device design envelope is similar to the predicate / reference devices (K191028, K210731, K203282, K170272).
The subject device has equivalent mechanical performance to the reference device ● (K953385).
Sterility assurance level of 1x10-6

Differences to Predicate

The following differences exist between the subject and predicate devices:

The subject and predicate device may both be additively manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F136. However, the primary predicate device may also be subtractively manufactured from commercially pure titanium per ASTM F67. The absence of this design configuration does not raise new concerns for substantial equivalence.
The subject device is indicated for both adolescents (greater than 12 to 21 years of age) and adults while the patient population in the predicate device is not specified. The use of patient specific facial implants in adolescent populations in identical to that seen in the reference devices (K210731, K170272). As such, this difference does not raise new concerns for substantial equivalence.
. The predicate device includes mandibular plates for treatment of continuity mandibular defects while the subject device is only intended to treat non-continuity mandibular defects. This difference is addressed via a design envelope appropriate for the intended use and labeling. As such, this difference does not raise new concerns for substantial equivalence.

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Biocompatibility Testing

Biocompatibility testing was conducted in accordance with international standard ISO 10993-1. ISO10993-5, and FDA guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The results of the testing adequately address biocompatibility for the plates and their intended use.

Sterilization Validation

A sterilization validation was conducted in accordance with international standard ISO 17665-1, ISO 17665-2, and FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" to a sterility Assurance Level (SAL) of 10th All test method acceptance criteria were met.

Non-Clinical Performance Testing

Performance testing for the MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is summarized below:

Static and Dynamic Bending per ASTM F382 The subject device was shown to have . equivalent bending strength and fatigue life as the reference device (K953385).
Axial Screw Pushout per ASTM F543 The subject device plate / screw interface was . shown to have equivalent axial screw pushout strength as the reference device (K953385).
. Fit and Form Validation – The subject device patient specific design process was shown to produce devices that aligned with the approved surgical plan.

Conclusions

Based on the similarities of the intended use/indications for use, technological and functional characteristic, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate device.

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Table 1 – Comparison of Technological Characteristics

Trait	Proposed Subject DeviceMedCAD AccuPlate® 3DTiPatient-Specific Plate	Primary Predicate DeviceKLS Martin IndividualPatient SolutionsK191028	Reference DeviceWalter Lorenz Surgical,Inc. Lorenz SystemK953385	Reference DeviceKLS Martin IndividualPatient SolutionsK210731	Reference DeviceIndustrias MedicasSampedro S.A.S.TECHFIT Patient-SpecificMaxillofacial SystemK203282	Reference DeviceMaterialize N.V.TruMatch CMF Titanium3D Printed Implant SystemK170272
Purpose	Subject Device	Same Indications	Similar Dimensions andPerformance	Similar Dimensions andPatient Population	Similar Dimensions (MidfaceHole Spacing)	Similar Dimensions (OrbitalPlate Thickness)
Product Code	JEY	JEY	JEY	JEY	JEY	JEY
Device Class	Class II	Class II	Class II	Class II	Class II	Class II
Regulation	21 CFR 872.4760	21 CFR 872.4760	21 CFR 872.4760	21 CFR 872.4760	21 CFR 872.4760	21 CFR 872.4760
Indications forUse	The MedCAD® AccuPlate®3DTi Patient-Specific PlatingSystem is intended for use inthe stabilization, fixation, andreconstruction of themaxillofacial / midface andmandibular skeletal regionsin adolescents (greater than12 to 21 years of age) andadults.	KLS Martin Individual PatientSolutions implant devices areintended for use in thestabilization, fixation, andreconstruction of themaxillofacial / midface andmandibular skeletal regions.	These devices areimplantable bone plates andbone screws for facialprocedures including:1. Fractures2. Osteotomies3. Reconstructiveprocedures4. Revision procedureswhere othertreatments or deviceshave failed	KLS Martin IndividualPatient Solutions (IPS) isintended as a pre-operativesoftware tool for simulating /evaluating surgical treatmentoptions as a software andimage segmentation systemfor the transfer of imaginginformation from a medicalscanner such as a CT basedsystem. The input data file isprocessed by the IPSsoftware and the result is anoutput data file that may thenbe provided as digital modelsor used as input in an additivemanufacturing portion of thesystem that produces physicaloutputs including implants,anatomical models, guides,splints, and case reports foruse in maxillofacial, midface,& mandibular surgery.KLS Martin IndividualPatient Solutions (IPS)implant devices are intendedfor use in the stabilization,fixation, and reconstructionof the maxillofacial / midfaceand mandibular skeletalregions in children (2 yearsof age to < 12 years of age),adolescents (12 years of age -21 years of age), and adults.	TECHFIT Patient-SpecificMaxillofacial System isintended for use in thestabilization, fixation, andreconstruction of themaxillofacial/midface andmandibular skeletal regions.	The TruMatch CMFTitanium 3D Printed ImplantSystem is intended for bonerepositioning, fixation andreconstruction of themaxillofacial skeleton,midface, mandible and chinin adolescents (greater than12 to 21 years of age) andadults.Specific indications for use:● Orthognathic surgery● Reconstructivemandible andmaxillofacial surgery● Mandible andmaxillofacial traumasurgery.
Sterility	Provided non-sterileSteam SterilizedSAL 10-6	Provided non-sterileSteam SterilizedSAL 10-6	Provided non-sterileSteam SterilizedSAL 10-6	Provided non-sterileSteam SterilizedSAL 10-6	Provided non-sterileSteam SterilizedSAL 10-6	Provided non-sterileSteam SterilizedSAL 10-6
PatientPopulation	Adolescents (12 - 21 years ofage)Adults (21+ years of age)	Unknown	Unknown	Children (2 - 12 years of age)Adolescents (12 - 21 years ofage)Adults (21+ years of age)	Unknown	Adolescents (12 - 21 years ofage)Adults (21+ years of age)
Trait	Proposed Subject DeviceMedCAD AccuPlate® 3DTiPatient-Specific Plate	Primary Predicate DeviceKLS Martin IndividualPatient SolutionsK191028	Reference DeviceWalter Lorenz Surgical,Inc. Lorenz SystemK953385	Reference DeviceKLS Martin IndividualPatient SolutionsK210731	Reference DeviceIndustrias MedicasSampedro S.A.S.TECHFIT Patient-SpecificMaxillofacial SystemK203282	Reference DeviceMaterialize N.V.TruMatch CMF Titanium3D Printed Implant SystemK170272
Physical Shape	Patient Specific Criteria(manufactured to finalgeometry)	Patient Specific Criteria(manufactured to finalgeometry)	Patient Specific Criteria (bentto final geometry duringsurgery)	Patient Specific Criteria(manufactured to finalgeometry)	Patient Specific Criteria(manufactured to finalgeometry)	Patient Specific Criteria(manufactured to finalgeometry)
AnatomicalLocations	• Orbital• Midface / Maxillofacial• Mandible	• Orbital• Midface / Maxillofacial• Mandible	• Orbital• Midface / Maxillofacial• Mandible	• Orbital• Midface / Maxillofacial• Mandible	• Midface / Maxillofacial• Mandible	• Orbital• Midface / Maxillofacial• Mandible
Material	Ti-6AL-4V Extra LowInterstitial (ELI) TitaniumAlloy (Grade 23) per ASTMF136	Surgical Guides:Epoxy/Acrylic ResinsImplants: Commercially PureTitanium per ASTM F67 orTi-6AL-4V ELI per ASTMF136Commercially PureTitanium per ASTM F67	Commercially Pure Titaniumper ASTM F67	Surgical Guides:Epoxy/Acrylic ResinsImplants: Commercially PureTitanium per ASTM F67 orTi-6AL-4V ELI per ASTMF136	Commercially Pure Titaniumper ASTM F67	Commercially Pure Titaniumper ASTM F67
ManufacturingMethod	3D Printed (AdditiveManufacturing)	Traditional (Subtractive)3D Printed (AdditiveManufacturing)	Traditional (Subtractive)	Traditional (Subtractive)3D Printed (AdditiveManufacturing)	Traditional (Subtractive)	3D Printed (AdditiveManufacturing)
Plate Thickness	Orbital:0.6mm - 1.2mmMaxillofacial / Midface:0.8mm - 2.0mmMandibular (Non-ContinuityDefects):0.8mm - 2.0mm	Orbital:0.3mm - 1.0mmMaxillofacial / Midface:0.6mm - 10mmMandibular Reconstruction:1.0mm - 3.0mm	0.2mm - 2.6mm	Orbital:0.3mm - 1.0mmMaxillofacial / Midface:0.6mm - 10mmMandibular (Non-ContinuityDefects):0.6mm - 10mmMandibular (ContinuityDefects):2.0mm - 10mm	Maxillofacial / Midface :0.6 mm - 2.0 mmMandibular:2.0 mm - 3.0 mm	Orbital:0.8mm - 1.2mmMaxillofacial / Midface:0.8mm - 3.0mmMandibular:0.8mm - 3.0mm
Trait	Proposed Subject DeviceMedCAD AccuPlate® 3DTiPatient-Specific Plate	Primary Predicate DeviceKLS Martin IndividualPatient SolutionsK191028	Reference DeviceWalter Lorenz Surgical,Inc. Lorenz SystemK953385	Reference DeviceKLS Martin IndividualPatient SolutionsK210731	Reference DeviceIndustrias MedicasSampedro S.A.S.TECHFIT Patient-SpecificMaxillofacial SystemK203282	Reference DeviceMaterialize N.V.TruMatch CMF Titanium3D Printed Implant SystemK170272
Plate Width	Orbital:Min: ≥ 3.9 mm (around screwholes)Min: ≥ 2.5 mm (not aroundscrew hole)Maxillofacial / Midface:Min: ≥ 4.5 mm (around screwholes)Min: ≥ 2.5 mm (not aroundscrew hole)	Maxillofacial / Midface:Min: ≥ 4.5 mm (aroundscrew holes)Min: ≥ 3 mm (not aroundscrew hole)Max: Dependent onscrew-holeMandibular:Min: 7 mmMin: 8.5mm	Unknown	Orbital:Min: ≥ 3.5 mm (around screwholes)Min: ≥ 2.2 mm (not aroundscrew hole)Maxillofacial / Midface:Min: ≥ 4.5 mm (around screwholes)Min: ≥ 2.2 mm (not aroundscrew hole)	Maxillofacial / Midface:Min: ≥ 4.5 mm (around screwholes)Min: ≥ 3 mm (not aroundscrew hole)Mandibular:Min: 6.63 mmMax: 16 mm	Orbital:0.6mm - 1.2mmMaxillofacial / Midface:0.8mm - 2.0mmMandibular (Non-ContinuityDefects):0.8mm - 2.0mm
	Mandibular (Non-ContinuityDefect):Min: ≥ 4.5 mm (around screwholes)Min: ≥ 2.5 mm (not aroundscrew hole)			Mandibular (Non-ContinuityDefect):Min: ≥ 4.5 mm (around screwholes)Min: ≥ 2.2 mm (not aroundscrew hole)Mandibular (ContinuityDefect):Min: ≥ 6.4 mm (around screwholes)Min: ≥ 3.2 mm (not aroundscrew hole)
Number of Holes	Orbital, Mandibular,Maxillofacial /Midface:Min: ≥2 per side of defectMax: Dependent onlength & hole spacing	Orbital & Maxillofacial /Midface:Min: ≥ 2 per side of defectMax: Dependent on length& hole spacingMandibular:Min: 4Max: Dependent on length& hole spacing	Unknown	Orbital, Mandibular,Maxillofacial /Midface: ≥ 2 per side ofdefect	Maxillofacial/midface:Min: ≥ 2 per side ofdefectMax: Dependent onlength & hole spacingMandibular:Min: 4Max: Dependent onlength & hole spacing	Unknown
Hole Spacing	Orbital:≥4.0mmMaxillofacial / Midface:≥4.0mmMandibular (Non-ContinuityDefects):≥4.5mm	Orbital & Maxillofacial /Midface:≥4.5mmMandibular:≥8.0mm	Unknown	Orbital:≥3.5mmMaxillofacial / Midface:≥4.5mmMandibular (Non-ContinuityDefects):≥4.5mmMandibular (ContinuityDefects):≥6.4mm	Maxillofacial:≥ 4.5 mmMidface:≥ 4.0 mmMandibular:≥ 8 mm	Unknown
Trait	Proposed Subject DeviceMedCAD AccuPlate® 3DTiPatient-Specific Plate	Primary Predicate DeviceKLS Martin IndividualPatient SolutionsK191028	Reference DeviceWalter Lorenz Surgical,Inc. Lorenz SystemK953385	Reference DeviceKLS Martin IndividualPatient SolutionsK210731	Reference DeviceIndustrias MedicasSampedro S.A.S.TECHFIT Patient-SpecificMaxillofacial SystemK203282	Reference DeviceMaterialize N.V.TruMatch CMF Titanium3D Printed Implant SystemK170272
Plate Length	Orbital:16mm - 50mMaxillofacial / Midface:18mm - 350mmMandibular (Non-ContinuityDefects):18mm - 350mm	Orbital & Maxillofacial /Midface:18 - 350mmMandibular:31 - 320mm	Unknown	Orbital:10.5mm - 50mMaxillofacial / Midface:18mm - 350mmMandibular (Non-ContinuityDefects):18mm - 350mmMandibular (ContinuityDefects):25mm - 350mm	Maxillofacial / Midface:18mm - 350mmMandibular:78mm - 320mm	Orthognathic:20mm maximumadvancementOrbital:5.5mm - 45mmMaxillofacial / Midface /Mandibular:20 mm maximum bridging ofosteotomy gap; Small: 20-120mm, Large: 20-294mm
Plate Holes	No locking threads	Locking threads optional	Locking threads optional	Locking threads optional	Unknown	Unknown
Degree ofCurvature	Orbital:In Plane: 30° - 180°Out of Plane: 15° - 180°Maxillofacial / Midface:In Plane: 30° - 180°Out of Plane: 15° - 180°Mandibular (Non-ContinuityDefects):In Plane: 30° - 180°Out of Plane: 15° - 180°	Maxillofacial / Midface:In Plane: 30° - 180°Out of Plane: 15° - 180°Mandibular:In Plane: 90° - 180°Out of Plane: 60° - 180°	Unknown	Orbital:In Plane: 30° - 180°Out of Plane: 15° - 180°Maxillofacial / Midface:In Plane: 30° - 180°Out of Plane: 15° - 180°Mandibular (Non-ContinuityDefects):In Plane: 30° - 180°Out of Plane: 15° - 180°Mandibular (ContinuityDefects):In Plane: 30° - 180°Out of Plane: 15° - 180°	Maxillofacial / Midface:In Plane: 30° - 180°Out of Plane: 15° - 180°Mandibular:In Plane: 90° - 180°Out of Plane: 60° - 180°	Orthognathic:0° - 119°Orbital:12°/mm lengthMaxillofacial / Midface:12°/mm lengthMandibular:12°/mm length
CompatibleScrew Diameter	Orbital:1.5mmMaxillofacial / Midface:1.5mm - 2.3mmMandibular:2.0mm - 2.7mm	Orbital:1.5mmMaxillofacial / Midface:1.5mm - 2.3mmMandibular:2.0mm - 3.2mm	1.5mm - 2.7mm	Orbital:1.5mmMaxillofacial / Midface:1.5mm - 2.3mmMandibular:2.0mm - 3.2mm	Unknown	Unknown
CompatibleScrew Length	Orbital:3.5mm - 22mmMaxillofacial / Midface:3.5mm - 22mmMandibular:3.5mm - 22mm	Orbital:3.5mm - 22mmMaxillofacial / Midface:3.5mm - 22mmMandibular:5mm - 22mm	3.5mm - 18mm	Orbital:3.5mm - 22mmMaxillofacial / Midface:3.5mm - 22mmMandibular:5mm - 22mm	Unknown	Unknown

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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.