The Optimus NEURO System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.8mm in lengths of 3.0 to 6.0mm. It is made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.

The device is packed separately in a PE bag. The plate and screw are single use only, non-sterile products. The devices must be sterilized before use.

Optimus NEURO System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient

AI/ML Overview

This document describes the Optimus Neuro System, a device intended for use in cranial surgery and reconstructive procedures. It's important to note that this submission focuses on the device itself (plates and screws), not an AI algorithm. Therefore, many of the requested AI-specific details are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion (Type of Test)	Acceptance Criteria (Implied)	Reported Device Performance
4 Point Bending Test	Subject device performance should be comparable or superior to the predicate device.	"The test results of the subject device were overall higher than the predicate devices..."
Packaging Process Validation Test	Packaging must ensure device integrity and sterility until use.	Test performed, implied successful.
Sterilization Parameters Validation	Device must be able to be effectively sterilized.	Supported by primary predicate K141911.
Biocompatibility	Device materials must be biocompatible.	Supported by primary predicate K141911.
Functional Equivalence	Differences in shape and dimensions should not raise new issues in safety and performance.	"performance test data provided in this submission proves that this differences do not raise new issues in safety and performance."

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

The document does not explicitly state the sample sizes used for the "4 Point Bending Test" or "Packaging Process Validation Test." It refers to "the subject device and the predicate devices," suggesting that a sufficient number of units were tested to draw conclusions.

Data Provenance: The manufacturing company, Osteonic Co., Ltd., is based in Seoul, Korea. The tests were likely conducted in a controlled lab environment. The study is retrospective in the sense that it's comparing a modified device to an existing predicate, and the testing isn't on human subjects for clinical outcomes, but rather on the physical properties of the device.

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

This information is not applicable as this is a submission for a medical device (plates and screws), not an AI algorithm requiring expert ground truth for image or data interpretation. The "ground truth" here is based on engineering standards and physical test results.

4. Adjudication Method for the Test Set

This is not applicable as it pertains to expert disagreement in AI-driven diagnostic tasks, which is not relevant to this device's testing.

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 is not applicable as this is a medical device (plates and screws), not an AI algorithm.

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

This is not applicable as this is a medical device (plates and screws), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Engineering Standards: Adherence to material specifications (ASTM F67, ASTM F136) and performance standards (e.g., implied stress/strain limits for the 4-point bending test).
Physical Test Results: Direct measurements of mechanical properties (bending strength) and packaging integrity.
Previous Validation Data: Relying on sterilization and biocompatibility data from the primary predicate device (K141911).

8. The Sample Size for the Training Set

This is not applicable as this is a medical device (plates and screws) and does not involve AI or machine learning models that require a training set.

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

This is not applicable for the same reasons as above.

Summary

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January 2, 2019

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Osteonic Co., Ltd % Jung Hyeon Park Official Correspondent BT Solutions, Inc. 904, Eonju-ro 68-gil 5, Gangnam-gu Seoul, 06210 Kr

Re: K183352

Device Name: Optimus Neuro System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: November 29, 2018 Received: December 3, 2018

Dear Jung Hyeon Park:

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 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-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,

Image /page/1/Figure/7 description: The image shows a digitally signed document by John Marler. The signature includes the date 2019.01.02 and a timestamp of 21:09:44 -05'00'. The document is addressed to Carlos L. Peña, who holds a PhD and MS degree and serves as the Director of the Division of Neurological and Physical Medicine Devices, within the Office of Device Evaluation and the 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: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K183352

Device Name

Optimus Neuro System

Indications for Use (Describe)

Optimus Neuro System is intended for use in selective trauma of the cranial surgery and reconstructive procedure.

Type of Use (Select one or both, as applicable)
	XPrescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date: November 16, 2018

1. Applicant / Submitter:

Osteonic Co., Ltd. 1206ho, 38, Digital-ro 29-gil Guro-gu, Seoul, Korea, (Postcode 08381) Tel :+82-2-6902-8411Fax : +82-2-6902-8401

2. Submission Correspondent

Do Hvun Kim BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu, Seoul, 06210, Republic of Korea Fax: +82-2-539-9140 Tel: +82-2-538-9140 Email: smanager@btsolutions.co.kr

3. Device:

· Proprietary Name OPTIMUS NEURO SYSTEM
· Common Name Neuro Plating System
· Classification Name Preformed Alterable Cranioplasty Plate; Burr hole cover; Cranioplasty plate fastener

4. Predicate Device:

트 Primary Predicate Device: K141911-OPTIMUS NEURO SYSTEM by Osteonic Co., Ltd.

5. Product Code & Regulation Number:

" Primary GWO, GXR, HBW (21CFR§882.5320, 21CFR§882.5250. 21CFR8882.5360)

6. Device Description:

The device is packed separately in a PE bag. The plate and screw are single use only, non-sterile products. The devices must be sterilized before use.

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7. Indication for use:

Optimus NEURO System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

8. Non-clinical tests:

There are a number of differences between the unmodified devices and the modified devices as presented in this submission, however, the differences were evaluated through design control, risk analysis and verification & validation activities, and test results demonstrated that the differences do not raise a question of safety and effectiveness.

The following tests were performed on the subject device and the predicate devices.

4 Point Bending Test
י Packaging Process Validation Test

The test results of the subject device were overall higher than the predicate devices supporting that the subject device is substantially equivalent to the predicate devices. Validation of sterilization parameters and biocompatibility of the submission device are supported by sterilization validation and biocompatibility testing as provided in the primary predicate K141911

9. Substantial Equivalence:

The subject device has the same device characteristics as the predicate (unmodified) device. They have the same intended use, raw material, and use concept and employ the same manufacturing processes including anodization and sterilization method. The differences are in shape and dimensions; however; the performance test data provided in this submission proves that this differences do not raise new issues in safety and performance.

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	Subject Device	Unmodified (Predicate)Device	Equivalence
Manufacturer	OSTEONIC Co., Ltd.	OSTEONIC Co., Ltd.	-
Device Name	OPTIMUS NEUROSYSTEM	OPTIMUS NEUROSYSTEM	-
510(K) #	-	K141911	-
Class	2	2	Equivalent
Product Code	GWO, GXR, HBW	GWO, GXR, HBW	Equivalent
Intended Use	Optimus NEURO System isintended for use in selectivetrauma of the cranialskeleton, cranial surgeryand reconstructiveprocedure.	Optimus NEURO Systemis intended for use inselective trauma of thecranial skeleton, cranialsurgery and reconstructiveprocedure.	Equivalent
Material(Chemicalcomposition)	•Plate- Pure TitaniumASTM F67•Screw- Titanium AlloyASTM F136	•Plate- Pure TitaniumASTM F67•Screw- Titanium AlloyASTM F136	Equivalent
SurfaceTreatment	• Plate: Anodizing• Screw: Anodizing	• Plate: Anodizing• Screw: Anodizing	Equivalent
Shape andDimension	D-Y Shape, Y-Shape, Burrhole Plate and mesh withvarious length andthickness (0.3 to 0.6mm).	Straight, angle, Y-shape,X-shape, burr hole, square,matrix and mesh withvarious lengths andthicknessPlate has various lengthand thickness (0.1 to0.6mm). The screws rangein diameters of 0.8 to1.8mm and lengths from3.0 to 6.0mm	Plates were found to be safeand effective through standardstrength testing methods.
Single Use	YES	YES	Equivalent
Sterile	Non sterile, steamsterilization before use	Non sterile, steamsterilization before use	Equivalent

10. Conclusions:

Based on documentation supplied with this submission, conclusions drawn from design control, risk analysis and verification & validation activities demonstrate that the subject devices are substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.5320 Preformed alterable cranioplasty plate.

(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).