Optimus CMF System is implantable bone screws for maxillofacial and mandible surgery procedures including: 1. Fractures - 2. Osteotomies - 3. Reconstructive procedures - 4. Revision procedures where other treatments or devices have failed.

Device Description

The OPTIMUS CMF SYSTEM comprises plates and screws. The plate thickness sizes range from 0.4 to 2.6mm. They are made of unalloyed Titanium (ASTM F67) and anodized in four colors (silver, blue, green, and gold). The diameters of the screws range from 1.3 to 2.7mm, while lengths range from 3.0 to 20.0mm. They are made of Ti-6A1-4V ELI titanium alloy (ASTM F136) and anodized in six colors (light blue, silver, purple, blue, gold and green). The plates and screws are single use only, non-sterile products. They must be sterilized before use.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Optimus CMF System, which is a medical device consisting of implantable bone plates and screws for maxillofacial and mandible surgery. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a comparative study with a ground truth.

Therefore, many of the requested details about acceptance criteria and a study proving their attainment are not directly available in this type of regulatory submission. The document primarily describes non-clinical testing performed to show the device's performance and safety.

Here's an analysis based on the provided document, highlighting what is (and isn't) present:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" for clinical performance metrics (like sensitivity, specificity, accuracy) alongside reported device performance in a clinical setting. Instead, it details non-clinical testing to demonstrate the device's physical and biocompatibility performance against established standards.

Acceptance Criteria (Implied by Standards) & Reported Device Performance:

Acceptance Criteria (Implied by Standard)	Reported Device Performance (Summary)
Mechanical Performance:
- ASTM F382-99(2008)e1 (4-Point Bending)	Test results supported substantial equivalence to predicate devices.
- ASTM F543-13e1 (Torsion and Axial Pullout Strength)	Test results supported substantial equivalence to predicate devices.
Biocompatibility:
- ISO 10993-5 (Cytotoxicity)	Test results supported substantial equivalence to predicate devices.
- ISO 10993-10 (Sensitization)	Test results supported substantial equivalence to predicate devices.
- ISO 10993-3 (Genotoxicity)	Test results supported substantial equivalence to predicate devices.
- ISO 10993-6 (Implantation)	Test results supported substantial equivalence to predicate devices.
Sterilization Validation:
- ANSI/AAMI ST79, ISO 17665-1, ISO 11737-1, USP 30-NF25 <61> (Microbial Limited Test)	Test results supported substantial equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is non-clinical (mechanical, biocompatibility, sterilization) and typically involves samples of the device components, not human subjects or clinical data sets in the way an AI diagnostic device would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The device is an implantable bone plate and screw system, not an AI diagnostic tool that requires expert-established ground truth from clinical data. The performance is assessed through standardized engineering and biological tests, not expert interpretation of images or other data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. As explained above, this is not an AI diagnostic study where adjudication of expert opinions would be necessary.

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

This information is not applicable and not provided. The Optimus CMF System is a physical implantable device, not an AI software for diagnostic assistance. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

This information is not applicable and not provided. This device is not an algorithm or AI system, so standalone performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as it applies to diagnostic accuracy studies is not applicable to this device. For the non-clinical tests performed, the "ground truth" is established by the accepted scientific and engineering principles underpinning the ASTM and ISO standards (e.g., precise measurement of force, observation of cellular reactions, sterility checks). The performance is compared against the requirements of these standards and against predicate devices.

8. The sample size for the training set

This information is not applicable and not provided. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

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

Summary

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

January 20, 2015

Osteonic Co., Ltd C/O Ms. Priscilla Chung Official Correspondent LK Consulting Group USA, Inc. 2651 E. Chapman Ave., Ste. 110 Fullerton, CA 92831

Re: K140037

Trade/Device Name: Optimus CMF System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY, DZL Dated: December 9, 2014 Received: December 12, 2014

Dear Ms. Chung:

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.

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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 (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); 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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,

Tina Kiang -S

for Erin I. Keith, M.S. 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) K140037

Device Name OPTIMUS CMF SYSTEM

Indications for Use (Describe)

Optimus CMF System is implantable bone screws for maxillofacial and mandible surgery procedures including: 1. Fractures

1. Osteotomies
1. Reconstructive procedures
1. Revision procedures where other treatments or devices have failed.

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).

Date:

1. Applicant / Submitter:

OSTEONIC Co., Ltd. 505-3Ho, Digital-ro 29-gil, Guro-gu, Seoul, Republic of Korea 152-779 Tel: +82-2-6082-8885

2. Submission Correspondent

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110. Fullerton CA 92831 Email: juhee.c@lkconsultinggroup.com

3. Device:

· Proprietary Name OPTIMUS CMF SYSTEM
Common Name Dental Bone Plate & Screw System
· Classification Name Dental Bone Plate
- Screw, fixation, intraosseous

4. Predicate Device:

· LeForte System Bone Plate & Screw by Jeil Medical Corporation (K112457)
· Synthes Matrix Mandibule Plate and Screw System by Synthes Inc. ( K113567)
· Biomet Microfixation Facial Plating System by Biomet Microfixation (K121589)
= Synthes (USA) Midfacial System by Synthes (USA) (K953806)
= Synthes 1.3mm Self-Drilling Screw by Synthes (USA) (K983485)
Leibinger IMF Screw by Howmedical Leibinger, Inc. (K963030)
= Synthes (USA) Craniofacial Plates by Synthes (USA) (K040272)
· Leforte System Bone Plate by Jeil Medical Coporation (K091679)

5. Product Code & Regulation Number:

· JEY (21CFR872.4760)
· DZL (21CFR872.4880)

6. Description:

The OPTIMUS CMF SYSTEM comprises plates and screws. The plate thickness sizes range from 0.4 to 2.6mm. They are made of unalloyed Titanium (ASTM F67) and anodized in

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four colors (silver, blue, green, and gold). The diameters of the screws range from 1.3 to 2.7mm, while lengths range from 3.0 to 20.0mm. They are made of Ti-6A1-4V ELI titanium alloy (ASTM F136) and anodized in six colors (light blue, silver, purple, blue, gold and green). The plates and screws are single use only, non-sterile products. They must be sterilized before use.

7. Indication for use:

Optimus CMF System is implantable bone plates and bone screws for maxillofacial and mandible surgery procedures including:

1. Fractures
1. Osteotomies
1. Reconstructive procedures
1. Revision procedures where other treatments or devices have failed.

8. Non-Clinical Testing:

The following tests were performed to validate the performance and the safety of the subject device and the test results supported substantial equivalence to the predicate devices.

י 4-Point Bending test in accordance with ASTM F382-99(2008)e1
י Torsion and Axial Pullout Strength Test in accordance with ASTM F543-13e1
Cytotoxicity test in accordance with ISO 10993-5 י
' Sensitization test in accordance with ISO 10993-10
י Genotoxicity test in accordance with ISO 10993-3
트 Implantation test in accordance with ISO 10993-6
י Sterilization validation test in accordance with ANSI/AAMI ST79, ISO 17665-1. ISO 11737-1, and USP 30-NF25 <61> Microbial Limited Test.

9. Substantial Equivalence:

The subject and predicate device(s) share the same intended use, primary design and equivalent material of manufacture. Any minor differences do not impact device performance as compared to the predicate devices and demonstrate that the Optimus CMF System is substantially equivalent to the predicate devices. The performance test results support that the subject device performs as well as the predicate devices.

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	Subject Device	Predicate Device 1	Predicate Device 2	Predicate Device 3	Predicate Device 4	Predicate Device 5	Predicate Device 6	Predicate Device 7	Predicate Device 8
Company	OSTEONICCo., Ltd.	Jeil Medicalcorporation	Synthes	BiometMicrofixation	Synthes	Synthes	HowmedicaLeibinger Inc.	Synthes	Jeil MedicalCoporation
DeviceName	OPTIMUSCMFSYSTEM	LeForte SystemBone Plate &Screw	MatrixMANDIBULE Plateand ScrewSystem	BiometMicrofixationFacial PlatingSystem	SYNTHES(USA)MIDFACIALSYSTEM	Synthes1.3mm Self-DrillingScrew	Leibinger IMFSscerw	SYNTHES(USA)CRANIOFACIAL PLATES	LEFORTESYSTEMBONE PLATE
510(K) #	N/A	K112457	K113567	K121589	K953806	K983485	K963030	K040272	K091679
Class	2	2	2	2	2	2	2	2	2
ProductCode	JEY, DZL	JEY, DZL	JEY	JEY	JEY	DZL	DZE	JEY	JEY
IntendedUse	Optimus CMFSystem isimplantablebone platesand bonescrews formaxillofacialand mandiblesurgeryproceduresincluding:1. Fractures2. Osteotomies3.Reconstructiveprocedures4. Revisionprocedureswhere othertreatments ordevices havefailed.	This device isintended for usein selectivetrauma of themid-face,reconstructionprocedures andselectiveorthognathicsurgery of themaxilla and chin	TheSynthesMatrixMANDI BULEPlate andScrew Systemis intended fororal,maxillofacialsurgery:• Trauma• Reconstructi-ve surgery• Orthognaticsurgery(surgicalcorrection ofdeformities)	These devices areimplantable boneplates and bonescrews for facialproceduresincluding:1. Fractures2. Osteotomies3. Reconstructiveprocedures4. Revisionprocedures whereother treatmentsor devices havefailed	Intended for usein selectivetrauma of themidface andcraniofacialskeleton;craniofacialsurgery;reconstructiveprocedures andselectiveorthognathicsurgery of themaxilla andchin.	Synthes1.3mm Self-DrillingScrews areintended forselectivetrauma of themidface andcraniofacialskeleton:craniofacialsurgery;reconstructiveprocedures;and selectiveorthognathicsurgery of themaxilla andchin.	Intended foruse intemporarymaxillomandibular fixation toprovide indirectstabilization ofthe maxilla,mandible orboth.	Intended foruse in selectivetrauma of themidface andcraniofacialskeleton;craniofacialsurgery;reconstructiveprocedures andselectiveorthognathicsurgery of themaxilla andchin.	This device isintended foruse in selectivetrauma of themid-face andcraniofacialskeletoncraniofacialsurgeryreconstructionprocedures andselectiveorthognathicsurgery of themaxilla andchin
Material	Plate -UnalloyedTitaniumScrew-Titanium Alloy	Plate -UnalloyedTitaniumScrew- TitaniumAlloy	UnalloyedTitanium	Plate - UnalloyedTitaniumScrew- TitaniumAlloy	UnalloyedTitanium	TitaniumAlloy	Titanium Alloy	UnalloyedTitanium	UnalloyedTitanium
Surface	Anodizing	Plate: AnodizingScrew: N/A	Anodizing	Plate: N/AScrew: Anodizing	Anodizing	Anodizing	-	Anodizing	Plate:Anodizing
Anodizingcolor	Light blue,silver, purple,	Silver, blue,green and gold	Silver, blue,green and gold	Silver, magenta,blue, green and	Silver, blue,green and gold	Silver, blue,green and gold	-	Silver, blue,green and gold	Silver, blue,green and gold
	blue, gold andgreen			gold		gold
Single Use	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Sterile	Non sterile	Non sterile	Sterile or non-sterile	Non sterile	Non sterile	Non sterile	Non sterile	Non sterile	Non sterile
Shape andDimensionof plate	Plate hasvarious shapes,length andthickness.Straight, Y, D-Y, X, L, Z,Square,Matrix,Orbital, ChinandReconstructiontypes withvariouslengths. Therange ofplate's profileis from 0.4 to2.6mmthickness and4 colors(silver, blue,green andgold).	Length5.2~~223.5mmThickness0.2~~2.5mm	The systemconsists of avariety ofplates offeredin multipleshape and sizesand a variety ofscrews offeredin multiplediameters andlengths to meetthe anatomicalneeds of thepatient.	The plates thatare the subject ofthis 510(k)submissioninclude variationsof straight, angle,curved, L-shape,T-shape, doubleT-shape, Z-shape,X-shape, Y-shape,double Y-shape,H-shape, triangle,square, rectangle,matrix, mesh,orbital floor,LeFort, and chinoptions withvarious lengthsand thickness.Plates are offeredflat or pre-bent.	The plate size isavailable in avariety ofconfigurationsto accommodatevarious fracturesites.	-	-	The synthesdoubleadaption platecan be cut ortrimmed to thedesired lengthtoaccommodatevariousfractures andmeet theanatomicalneed of thepatient. Theplate has a lowprofile head,uses 2.0mmself-tapping orself-drillingbone screwand 2.4mmemergencyscrew.	The systemconsists of avariety ofplates offeredin multipleshape andsizes.
ScrewSizes	The diameterof screw isfrom 1.3 to2.7mm inlengths of 3.0to 20.0mm and6 colors (lightblue, silver,purple, blue,gold andgreen).	Outer(head)diameter1.2~~2.65mmInner diameter0.7~~1.6mmLength4.0~18.0mm		Screw range indiameters of1.0mm to 2.3mmand lengths from2.0mm to29.0mm	Screw size is 1.3or 1.5mm.	Available inlengthsranging from4~6mm	2.0mm indiameter andranges from10.5 to 8.5mmin totallength(6~14mm in threadlength)	-

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10. Conclusions:

The subject and predicate device(s) share the same intended use, primary design and equivalent material of manufacture. The information provided in this submission including various test results support that the subject device is substantially equivalent to the predicate devices in the market.

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.