The Bio Architects Patient Specific Cranial/Craniofacial Plate implant device is intended to replace bony voids in the cranial and/or craniofacial skeleton (e.g., frontal bone, occipital bone, nasal bone, parietal bone, supraorbital process, lacrimal bone, zygomatic bone, ethmoid process, vomer). It is a patient specific device.

Device Description

The BioArchitects Patient Specific Cranial/Craniofacial Plate implant device is a single piece device constructed individually for each patient. It is intended to replace bony voids in the cranial and craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, nasal bone, parietal bone, supraorbital process, lacrimal bone, zygomatic bone, sphenoid bone, ethmoid process, vomer). It is a patient specific device. The implant is made of titanium alloy produced via Electron Beam Melting (EBM) additive manufacturing/3D printing, permitting high temperature fusion of the powdered raw material (Ti6Al4V ELI in accordance with ASTM F3001-14).

The BioArchitects plate implants come in a variety of configurations that depend upon the geometry of the application. The surgeon approves the design of the cranial/craniofacial plate by comparing his/her dimension and configuration specifications to an engineering drawing prior to construction of the implant device.

AI/ML Overview

The device under review is the BioArchitects Patient Specific Cranial/Craniofacial Plate. The document is a 510(k) summary for this device, which is intended to replace bony voids in the cranial and/or craniofacial skeleton.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria	Reported Device Performance
Cranial Plate Static Tensile Test	"tensile and elastic strength, with test results similar to those of predicate" (Implicitly, the device should not be weaker than the predicate, ideally stronger or comparable.)	"The BioArchitects Patient Specific Cranial/Craniofacial plate device has an average ultimate stress of approximately 8 times that of the comparable device with the highest ultimate stress. Furthermore, the BioArchitects Patient Specific Cranial/Craniofacial Plate device has an average Young's modulus of approximately 3 times that of the comparable device with the highest Young's modulus." (Exceeds predicate significantly)
Cranial Plate Tab Static Tensile Test	"tensile and elastic strength, with test results similar to those of predicate" (Implicitly, the device should not be weaker than the predicate, ideally stronger or comparable.)	"The BioArchitects Patient Specific Cranial/Craniofacial Plate device has an average tensile strength approximately 3.84 times that of the predicate fixation system." (Exceeds predicate significantly)

The acceptance criteria are generally qualitative for "similarity" to the predicate's mechanical properties, rather than specific numerical thresholds. The reported performance exceeds this qualitative criterion, showing significantly higher ultimate stress, Young's modulus, and tensile strength compared to predicate devices.

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

Sample Size for Test Set: The document does not specify a numerical sample size for the mechanical tests. It mentions "plate samples were cut into sections to prepare specimens for testing" for the Cranial Plate Static Tensile Test and "gage pins were placed through the screw hole... and the assembly placed in a gripping fixture" for the Cranial Plate Tab Static Tensile Test. The number of such specimens is not stated.
Data Provenance: The document does not provide information about the country of origin of the data or whether the study was retrospective or prospective. Given it's a mechanical performance study, these aspects are less relevant than for clinical studies.

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

This device is subject to a mechanical performance study, not a clinical study involving experts establishing ground truth for diagnostic accuracy. Therefore, this section is not applicable to the provided information. Mechanical tests rely on standardized methods and measurements rather than expert consensus on clinical findings.

4. Adjudication Method for the Test Set

Not applicable, as this is a mechanical performance study and not a clinical study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging algorithms to assess human reader performance with and without AI assistance. The provided document is for a physical implant device, and its performance is evaluated through mechanical testing.

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

Not applicable. This device is a physical implant, not an AI algorithm. Its performance is inherent to its physical properties, manufacturing, and design, and is tested mechanically, not as a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical performance tests are the measured physical properties (ultimate stress, Young's modulus, tensile strength) of the subject device and the predicate device(s) as determined through standardized mechanical testing methods. There is no pathology, outcomes data, or expert consensus used as ground truth in this context.

8. The Sample Size for the Training Set

The provided document describes mechanical testing of a physical device. It does not mention any "training set" in the context of machine learning or AI. Therefore, this question is not applicable to the information given. The device itself is "patient specific" meaning it is designed for individual patients based on their CT/MRI data, but this design process is not described as involving a machine learning training phase in the document.

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

Not applicable, as there is no "training set" mentioned or implied for this device in the provided document.

Summary

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

November 20, 2015

BioArchitects USA, LLC % Mr. Frank Ferguson CEO Ferguson Medical International Device Consultants LLC 332 Laskin Road, Suite 437 Virginia Beach, Virginia 23451

Re: K151692

Trade/Device Name: BioArchitects Patient Specific Cranial/Craniofacial Plate Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed Nonalterable Cranioplasty Plate Regulatory Class: Class II Product Code: GXN Dated: October 19, 2015 Received: October 20, 2015

Dear Mr. Ferguson:

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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -SA

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151692

Device Name

BioArchitects Patient Specific Cranial/Craniofacial Plate

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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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21CFR Part 807.92 for the BioArchitects Patient Specific Cranial/Craniofacial Plate implant device.

DATE PREPARED: 19 November 2015

APPLICANTS NAME AND ADDRESS:

BioArchitects USA, LLC Attn: Mark E. Ulrich, CEO 219 East 69th Street Suite 2K New York, NY 10021 Phone: 212.535.4050 marku@BioArchitects.com

APPLICANTS CONTACT PERSON:

Ferguson Medical International Device Consultants LLC Attn: Frank Ferguson, CEO 332 Laskin Road Suite 437 Virginia Beach, VA 23451 Phone: 757.286.4383 frankf@ferqusonmedical-idc.com

DEVICE NAME:

Common Name of the Device: Cranial or Craniofacial Plate Trade/Proprietary Name: BioArchitects Patient Specific Cranial/Craniofacial Plate Classification: 21 CFR 882.5330 Preformed Nonalterable Cranioplasty Plate Panel: 84 Product Code: GXN

LEGALLY MARKETED DEVICE TO WHICH BIOARCHITECTS IS CLAIMING SUBSTANTIAL EQUIVALENCE:

Primary Predicate Device: Synthes Patient Specific Cranial/Craniofacial Implant Reference Predicate Devices: Biomet HTR-PEKK Patient-(PSCI) (K053199). Matched Implant (K121818) and Medtronic TiMesh Pre-Shaped Cranial Mesh Implants (K974017).

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DEVICE DESCRIPTION:

INDICATIONS FOR USE:

The BioArchitects Patient Specific Cranial/Craniofacial Plate implant device is intended to replace bony voids in the cranial and/or craniofacial skeleton (e.q., frontal bone, temporal bone, occipital bone, nasal bone, parietal bone, supraorbital process, lacrimal bone, zygomatic bone, sphenoid bone, ethmoid process, vomer). It is a patient specific device.

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE:

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Feature/Characteristic	Subject Device	Synthes PatientSpecificCranial/CraniofacialImplant (PSCI)	Biomet HTR-PEKK Patient-Matched Implant	Medtronic TiMesh Pre-Shaped Cranial MeshImplants
510(k)		K053199	K121818	K974017
Product Code(s)	GXN	GXN	GXN	GXN
Classification	Class II	Class II	Class II	Class II
Intended Use	The BioArchitectsPatient SpecificCranial/CraniofacialPlate implant device isintended to replacebony voids in thecranial and/orcraniofacialskeleton (e.g., frontalbone, temporal bone,occipital bone, nasalbone, parietal bone,supraorbital process,lacrimal bone,zygomatic bone,sphenoid bone,ethmoid process,vomer). It is a patientspecific device.	Synthes (USA) PatientSpecificCranial/Craniofacialimplant is intended toreplace bony voids inthe cranial and/orcraniofacial skeleton.	The OsteoFAbPatient SpecificCranial Device(OPSCD) is intendedfor the replacementof bony voids in thecranial skeleton.	The TiMesh System isintended for use in anyoral-maxilo-cranial-facialsurgical reconstructiveprocedure, eitherorthnathic or trauma,wherein rigid or semi-rigidinternal fixation is utilized asa means of holding bonefragments together.Alternatively, the TiMeshSystem is also indicated foruse in reinforcing weak bonytissues in orthopedic surgicalrepairs, such as pelvicreconstruction, acetabularreconstruction, and cementrestriction. This product isnot intended for spinal use.
Material(s)	Titanium alloy	Commercially puretitanium or PEEK	PEKK	Titanium alloy
TechnicalSpecifications	Custom sized to eachpatient using CT orMRI data	Custom sized to eachpatient using CT data	Custom sized toeach patient usingCT data	Custom sized to eachpatient using CT data
ManufacturingMethod	3D printed usingelectron beam meltingadditive manufacturing	Machined	3D printed usinglaser sinteringadditivemanufacturing	Machined
Fixation Method	Commercially availablescrew systems	Synthes plates andscrew systems	Commerciallyavailable plate andscrew systems	Medtronic plates, screws,and wires
Sterilization	Non-sterile	Non-sterile	Non-sterile	Non-sterile

Both the subject device and all predicates are the same in that they all derive the patient imaging data from CT scan sources. The material used for the subject device is the same as the reference predicate.

Both the subject device and the Medtronic reference predicate are constructed from titanium allov, while the primary predicate has a different material, which may be either commercially pure titanium or PEEK (polyetheretherketone). The Biomet reference predicate is also manufactured from a material (PEKK, polyetherketone) which is also different from the titanium alloy of the subject device.

The manufacturing technologies differ among the devices. The subject device is most closely similar to the Biomet reference predicate: Both utilize an additive 3D printing manufacturing technique, the Biomet device manufactured using laser sintering while the subject device uses electron beam melting (EBM), which is also a type of sintering process.

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Both the primary predicate Synthes device and Medtronic predicate are fixed onto the bony surface using their own, captive screw and plate systems, while the subject device and the Biomet predicate utilize off-the-shelf commercially available screws.

Both the subject device and all predicates are the same in that devices are all shipped non-sterile to the end user.

PERFORMANCE DATA:

The BioArchitects Patient Specific Cranial/Craniofacial Plate was mechanically tested for tensile and elastic strength, with test results similar to those of predicate.

Performance Testing Summary Table

Test	Test Method Summary	Results
Cranial Plate StaticTensile Test	The objective of this test was toperform static tensile testing onsections of the BioArchitects PatientSpecific Cranial/Craniofacial Platedevice. Pate samples were cut intosections to prepare specimens fortesting.For the test setup, the upper tensilegrip was attached to the machineactuator using a U-joint. The lowertensile grip was attached to the axialbad eel. The plate specimen wasgripped at both ends, leaving twoholes exposed between the tensilegrips. A nominal gage length of30mm was used for each testspecimen. Photographs of the tensilestrength test setup are included in theTest Report.	The BioArchitects Patient SpecificCranial/Craniofacial plate device hasan average ultimate stress ofapproximately 8 times that of thecomparable device with the highestultimate stress. Furthermore, theBioArchitects Patient SpecificCranial/Craniofacial Plate device hasan average Young's modulus ofapproximately 3 times that of thecomparable device with the highestYoung's modulus.Results are presented in a side byside comparison table in the TestReport.
Cranial Plate TabStatic Tensile Test	The plate tab is the thinnest portion ofthe device, and therefore presents theworst case in terms of mechanicalstrength.The objective of this test was toperform a static tensile pull to failuretest on the subject device comparedto the predicate.For the test method, gage pins wereplaced through the screw hole in theattachment plate (tab) and theassembly placed in a gripping fixture.The test was conducted using ahydraulic actuator.	The BioArchitects Patient SpecificCranial/Craniofacial Plate device hasan average tensile strengthapproximately 3.84 times that of thepredicate fixation system.Specific results are presented in thetest report.

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CONCLUSIONS:

Based upon testing and comparison to the predicate device, the BioArchitects Patient Specific Cranial/Craniofacial Plate has the same intended use and similar technological characteristics. The device performs as intended and does not raise new safety or effectiveness issues.

Regulation Number and Section

§ 882.5330 Preformed nonalterable cranioplasty plate.

(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).