MedCAD® AccuPlate® Patient-Specific Plates are metal bone plates used in conjunction with commercially available metal bone screws for the fixation to bone, specifically in the areas of the mandible and maxilla. 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 plates are designed by MedCAD in consultation with the surgeon and manufactured by MedCAD only. MedCAD® AccuPlate® Patient-Specific Plates are not intended to be bent or modified in surgery. The MedCAD® AccuPlate® Patient-Specific Plates are manufactured from commercially pure titanium, are provided non-sterilized prior to use, and are intended for single use only. Plates are fastened to bone using commercially available bone screws with diameters ranging from 2.0 mm to 2.7 mm and lengths ranging from 4.0 mm to 23.0 mm.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the MedCAD® AccuPlate® Patient-Specific Plate. It is a medical device clearance document, not a study report for an AI/software device. Therefore, it does not contain the information typically presented for acceptance criteria and study results of an AI or software as a medical device (SaMD).

The document concerns a patient-specific bone plate used in oral and maxillofacial surgery. The "performance data" section refers to non-clinical functional and material testing (e.g., static and dynamic bending, screw pushout testing, sterilization, and biocompatibility validation) to demonstrate substantial equivalence to predicate devices, not performance metrics of an AI or software.

Therefore, I cannot provide the requested information regarding acceptance criteria and study results for an AI/software medical device because this document does not describe such a device or study.

Specifically:

A table of acceptance criteria and the reported device performance: The document mentions "All test method acceptance criteria were met" for sterilization validation and that mechanical tests showed the device "meets the performance of the predicate / reference devices." However, it does not provide specific acceptance values or performance metrics for these non-clinical tests in a table format that would be relevant to an AI/software device.
Sample sizes used for the test set and the data provenance: Not applicable to this type of device. The "test set" would refer to physical prototypes in mechanical testing, not a dataset for software.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device performance is established through engineering specifications and standardized testing protocols.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for clinical tasks, which is not the scope of this bone plate device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used: For physical performance testing, the ground truth is defined by engineering standards (e.g., ASTM F382 for bending, ISO 10993-1 for biocompatibility).
The sample size for the training set: Not applicable. This is a manufactured physical device, not an AI model.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 12, 2021

MedCAD % Linda Braddon President/CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188

Re: K193280

Trade/Device Name: MedCAD® AccuPlate® Patient-Specific Plate Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: January 11, 2021 Received: January 12, 2021

Dear Linda Braddon:

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 Actinclude 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.

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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) 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 (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.

for Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

K193280

Device Name

MedCAD® AccuPlate® Patient-Specific Plate

ndications for Use (Describe)

The MedCAD® AccuPlate® Patient-Specific Plate is intended for prescription use in oral and maxillofacial surgery, trauma and reconstructive surgery.

Specific Indications for Use:

Primary mandibular reconstruction with bone graft
Temporary bridging until delayed secondary reconstruction
Secondary mandibular reconstruction
Comminuted mandibular fractures
Fractures of edentulous and/or atrophic mandibles
Unstable mandibular fractures
Maxillary reconstruction with or without bone graft
Maxillary trauma

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)

□ Over-The-Counter Use (21 CFR 801

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of

information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)

Page 1 of 1

PSC Publishing Services(301)443-6740 EF

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510(k) Summary MedCAD® AccuPlate® Patient-Specific Plates K193280

February 10, 2021

Sponsor

MedCAD 501 S 2nd Ave, Suite A-1000 Dallas. TX 75226 (214) 453-8864 x305

Contact

Secure BioMed Evaluations Linda Braddon, Ph.D. 7828 Hickory Flat Highway Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory@SecureBME.com

Name of Device and Classification Name

Device Name: MedCAD® AccuPlate® Patient-Specific Plate Requlation Name: Bone Plate Regulation Number: 872.4760 Product Code: Primary - JEY Classification Panel: Dental

Predicate Device

Synthes Patient-Specific Plates (K122647)

Reference Devices

Stryker Customized Mandible Recon Plate Kit (K132519) Biomet Fracture/Reconstruction System Trauma One (K081067) MedCAD AccuShape™ PEEK Specific Cranial Implant (PSCI) (K110684)

Indication for Use:

The MedCAD® AccuPlate® Patient-Specific Plate is intended for prescription use in oral and maxillofacial surgery, trauma and reconstructive surgery.

Specific Indications for Use:

Primary mandibular reconstruction with bone graft
. Temporary bridging until delayed secondary reconstruction
Secondary mandibular reconstruction
Comminuted mandibular fractures

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Image /page/4/Picture/0 description: The image shows the logo for MedCAD. The text "Med" is in a large, bold, serif font, and the text "CAD" is in a sans-serif font inside of a blue box. There is a line underneath the text that extends from the left side of the "M" to the right side of the "D" in CAD.

Fractures of edentulous and/or atrophicmandibles .
. Unstable mandibular fractures
Maxillary reconstruction with or without bone graft
. Maxillary trauma

Device Description

Performance Data

Non-clinical testing was performed to demonstrate the MedCAD® AccuPlate® Patient-Specific Plates are substantially equivalent to other predicate / reference devices. The following comparative tests were performed:

· Static and dynamic 4 point bending per ASTM F382
· Screw pushout testing

The results of these studies show the subject MedCAD® AccuPlate® Patient-Specific Plates meets the performance of the predicate / reference devices, and the device was therefore found to be substantially equivalent.

Sterilization Validation

Sterilization validation was conducted in accordance with international standard ISO 17665-1 and FDA quidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." to a sterility Assurance Level (SAL) of 1x10°. All test method acceptance criteria were met.

Biocompatibility Validation

Biocompatibility validation was conducted in accordance with international standard ISO 10993-1 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.

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Image /page/5/Picture/0 description: The image shows the logo for MedCAD. The logo is composed of the word "Med" in a large, bold, black font, followed by "CAD" in a similar font but with the letters in white against a blue-green background. The "CAD" portion of the logo is contained within a rectangular shape.

Based on risk management , the following biocompatibility testing was conducted on the final, finished sterilized device:

. Cytotoxicity per ISO 10993-5
Scanning Electron Microscope (SEM) imaging and Energy Dispersive X-Ray . Spectroscopy (EDS) analysis for evaluation of the elemental analysis of the surface of the bone plate

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Substantial Equivalence

MedCAD® AccuPlate® Patient-Specific Plates are substantially equivalent to the identified predicate based on indications for use, principles of operation, material composition, and technological characteristics.

COMPARISON OF TECHNOLOGICAL CHARACTERISITICS
Features	Subject DeviceMedCAD®AccuPlate® Patient-Specific Plate(K193280)	Predicate DeviceSynthes PatientSpecific Plates(K122647)	Reference DeviceStryker CustomizedMandible Recon PlateKit(K132519)	Reference DeviceBiometFracture/ReconstructionSystem (Traumaone)(K081067)
Indications forUse	The MedCAD® AccuPlate®Patient-Specific Plateisintended for prescriptionuse in oral and maxillofacialtraumasurgery,andreconstructive surgery.Specific Indications for Use:Primary●mandibularreconstruction withbone graftTemporary●bridging untildelayed secondaryreconstructionSecondary●mandibularreconstructionComminuted●mandibularfracturesFracturesof●edentulous and/oratrophic mandiblesUnstable●mandibularfracturesMaxillary●reconstruction withor without bonegraftMaxillary trauma●	Synthes Patient SpecificPlates are intended foruse in oral andmaxillofacial surgery,trauma andreconstructive surgery.Specific Indications forUse:Primary●mandibularreconstructionwith bone graftTemporary●bridging untildelayedsecondaryreconstructionSecondary●mandibularreconstructionComminuted●mandibularfracturesFractures of●edentulousand/or atrophicmandiblesUnstable●mandibularfracturesMaxillary●reconstructionwith or withoutbone graftMaxillary trauma●	The CustomizedMandible Recon PlateKit is indicated foruse in primarymandibularreconstruction withbone graft,temporary bridging untildelayed secondaryreconstructionand secondarymandibularreconstruction.	Intended for use in thestabilization and fixationof mandibular fracturesand mandibularreconstructive surgicalprocedures.
Material	Commercially PureTitanium	Commercially PureTitanium	Commercially PureTitanium	Commercially PureTitanium
ManufacturingMethod	Subtractive	Subtractive	Subtractive	Subtractive
Sterility	Provided non-sterile	Provided non-sterile	Provided non-sterile	Provided non-sterile

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Image /page/7/Picture/0 description: The image shows the logo for MedCAD. The text "Med" is in a bold, black font, while "CAD" is in a white font inside of a blue-green box. There is a registered trademark symbol to the right of the box.

COMPARISON OF TECHNOLOGICAL CHARACTERISITICS
Features	Subject DeviceMedCAD®AccuPlate® Patient-Specific Plate(K193280)	Predicate DeviceSynthes PatientSpecific Plates(K122647)	Reference DeviceStryker CustomizedMandible Recon PlateKit(K132519)	Reference DeviceBiometFracture/ReconstructionSystem (Traumaone)(K081067)
PhysicalShape	Patient Specific Criteria	Patient Specific Criteria	Patient Specific Criteria	Generic Template that isbent to patient specificcriteria.
VisualAppearance	Opaque	Opaque	Opaque	Opaque
PlateThickness	2.0 mm and 2.8 mm	2.0 mm and 2.5 mm	2.0 mm and 2.8 mm	2.0 mm, 2.6 mm, 2.8 mm
Plate Height	8.25 mm Minimum	8.0 mm	6.5 mm / 7.6 mm	6.98 mm / 8.25 mm / 8.25mm
Hole Spacing(minimum)	7.5 mm for 2.0 mm Plate9.0 mm for 2.8 mm Plate	5.5 mm	7.6 mm for 2.0 mm Plate9.0 mm for 2.8 mmPlate	7.5 mm
Plate LengthMax lengthdefined bypatientanatomy	30 mm – 490 mm	24.5 mm – 490 mm	Not publicly disclosed	30 mm – 251 mm
Plate Holes	Locking Threads Optional	Locking Threads Optional	Locking ThreadsOptional	Locking Threads Optional
HoleAngulation	0°	0-15°	0-10°	0-15°
ScrewDiameter	2.0 mm, 2.3 mm,2.4 mm, 2.7 mm	2.4 mm or 2.9 mm	Not publicly disclosed.	2.0 mm, 2.3 mm, 2.7 mm
Shape Design	Mandible Hemi (L or R)Mandible Angle to Angle,Mandible Condyle toCondyle, Maxilla	"During the plate designprocess, surgeons willselect the options for theplate design, which mayinclude the following:Choose plate profile,Define plate trajectory"	"Full" or "Hemi"	Full Mandible (angle toangle), Left & Right Hemi-mandible (angle tosymphysis of chin),Straight Plate (no angle)
Range oflengths foreach shapedesign ormodel type	30 mm – 490 mm	24.5 mm – 490 mm	"Plate design is basedupon a CT scan of thepatient. Selectingspecific plate designfeatures like profileheight, length, and runof the plate allow for thecreation of patientspecific solutions"	30 mm – 251 mm
Maximumdimensionsfor eachshape designor model type	Thickness: 2.0 mm and2.8 mmLength: 30 mm – 490 mm	Thickness: 2.0 mm – 2.5mmLength: 24.5 mm – 490mm	Thickness:2.0 mm and 2.8 mmLength:Not publicly disclosed	Thickness:2.0 mm, 2.6 mm, 2.8 mmLength: 30 mm – 251 mm

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Comparison of Technological Characteristics with the Predicate Device

MedCAD® AccuPlate® Patient-Specific Plates are substantially equivalent to its predicate device (Synthes Patient Specific Plates - K122647).

Similarities to Predicate

The MedCAD® AccuPlate® Patient-Specific Plates 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 principals of operation and technological characteristics are either identical or substantially equivalent to the predicate / reference devices. The system has similar technological characteristics including:

Materials: Commercially pure titanium (proposed device and the reference ● (K081067) are manufactured from Grade 2 commercially pure titanium).
Plate thickness: The proposed device is offered in nominal thickness of 2.0 mm . and 2.8 mm. The thickness of the predicate / reference devices range from 2.0 mm to 2.8 mm.
. Technical Characteristics: The proposed device and predicate / reference devices share similar technical characteristics including available lengths, thicknesses, heights, curvatures, hole spacing, and material. The proposed device and the predicate / reference devices have hole features that are geometrically the same to accommodate commercially available fixation screws.
The proposed device and the reference (K110684) share the same fundamental . principles of processing the patient data (i.e. CT Scan) for use as input.
The proposed device and the predicate / references are manufactured similarly via . CNC milling.
. Sterility assurance level of 1x10-6

Differences to Predicate

The following differences exist between the subject and predicate / reference devices:

The proposed subject device is manufactured to the planned patient anatomy ● whereas the reference device(s) (Biomet and Stryker) are first manufactured flat, and then bent to match patient anatomy. This manufacturing difference does not create a new risk since the end product of both processes are designed to fit the patient and the performance testing is equivalent.
The proposed subject device is Grade 2 commercially pure titanium while the predicate device (K122647) utilize Grades 1,2,3,4, and 5 titanium. The differences in material do not create a risk for biocompatibility or mechanical performance.

Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate / reference devices, the subject MedCAD® AccuPlate® Patient-Specific Plates have been shown to be substantially equivalent to the predicate devices.

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.