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 3 colors (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, greenand gold) by anodizing. The plate and screw are a single use only, non-sterile product and they must be sterilized by the user before use. Each component is individually packed in a PE bag. 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

The provided text describes the "Optimus Neuro System," a medical device for cranial surgery and reconstructive procedures. However, the document primarily focuses on demonstrating substantial equivalence to predicate devices through bench testing (mechanical, sterilization, cleaning, and packaging validation), rather than a clinical study involving human or animal subjects that would typically involve acceptance criteria for diagnostic or clinical performance.

Therefore, the information required to directly answer some of your questions, particularly those related to a study proving diagnostic or clinical performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details), is not present in this document. This is common for devices like cranioplasty plates and screws, where substantial equivalence is often established through material testing, mechanical performance, and comparisons to existing devices with a long history of safe and effective use.

Here's a breakdown of what can be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Sterilization Validation Test	Sterility assurance level (SAL) of 10⁻⁶ for steam sterilization.	Sterility assurance level (10⁻⁶) for the recommended steam sterilization parameters is met.
Mechanical Test	Pre-set criteria for mechanical characteristics (not specified).	Worst case test articles have passed the pre-set criteria. The subject devices have been validated in mechanical characteristics.
Cleaning Process Validation	Bioburden level and endotoxin criteria of 2.15 EU/device.	The subject devices showed low bioburden level and met criteria of 2.15 EU/device for endotoxin. The cleaning process at the manufacturing sites has been validated.
Packaging Validation Test	Complete sealing of final packaging.	Final packaging of the subject device has passed the testing for its complete sealing. The subject device will be well protected until use in its packaging.

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not specified. The document refers to "worst case test articles" for mechanical testing, implying a limited number of samples were tested for each specified test type. These are bench tests on physical devices, not a clinical study on patient data.
Data Provenance: Not applicable in the context of a clinical test set. The tests described are laboratory/bench tests on manufactured devices, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for bench testing is established by technical specifications and validated test methods, not expert clinical consensus.

4. Adjudication method for the test set

Not applicable. This is not a clinical study with image interpretation or similar expert-dependent outcomes.

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

Not applicable. This device is a mechanical implant (plates and screws), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a mechanical implant, not an algorithm. Performance relates to its physical and material properties.

7. The type of ground truth used

For the bench tests, the ground truth or reference standard is based on pre-set criteria, technical specifications, and recognized standards (e.g., ASTM F67, ASTM F136 for materials, and established parameters for sterilization, bioburden, and packaging integrity).

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms.

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

Not applicable. As above, this is a mechanical device, not an AI model.

Summary of Study Type:

The "study" described in the provided text is a set of non-clinical bench tests and validation activities, typical for demonstrating the safety and performance of medical implants like cranioplasty plates and screws. These tests are designed to confirm material properties, mechanical strength, sterility, cleanliness, and packaging integrity, which are crucial for the intended use of such a device in surgery. The objective is to demonstrate substantial equivalence to already legally marketed predicate devices, primarily through engineering and material science evaluations, rather than clinical efficacy studies on patient outcomes or diagnostic accuracy.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.

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

February 9, 2015

OSTEONIC Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 E Chapman Ave. Suite 110 Fullerton, California 92831

Re: K141911

Trade/Device Name: OPTIMUS NEURO SYSTEM Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed alterable cranioplasty plate Regulatory Class: Class II Product Code: GWO, GRX, HBW Dated: January 5. 2015 Received: January 8, 2015

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.

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 remarket 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 -SFD/A

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) K141911

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)
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	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (K141911)

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

Date: 02/08/2015

1. 510K Applicant

OSTEONIC Co., Ltd.

505-3Ho, Digital-ro 29-gil, Guro-gu, Seoul, Republic of Korea Tel: +82-2-6082-8885 Fax: +82-2-6326-7001

2. US Agent/ Correspondent

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton, CA 92831 Priscilla Chung Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

Trade Name: OPTIMUS NEURO SYSTEM
Classification Name: Neuro Plating System
· Classification regulation: 21CFR§882.5320
21CFR § 882.5250 21CFR §882.5360 • Product Code: GWO, GRX, HBW

4. Predicate Device:

· Neuro plating system (K121624) by Biomet Microfixation
LEFORTE NEURO SYSTEM BONE PLATE and SCREW (K112812) by Jeil Medical Corporation
· Frontier Devices Neuro Closure System (K100205) by Frontier Devices

5. Device Description:

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lengths of 3.0 to 6.0mm. It is made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, greenand gold) by anodizing. The plate and screw are a single use only, non-sterile product and they must be sterilized by the user before use. Each component is individually packed in a PE bag.

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.

6. Indications for use:

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

7. Comparison to the Cleared Device

The subject device is similar to the predicate devices in terms of indications, materials, and design. All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices. There might be slight differences in dimensions and shapes between the subject device and each predicate device; however, the test results of non-clinical testing including mechanical testing provided in this submission proves substantial equivalence to the predicate devices.

8. Performance Data

Test	Result	Conclusion
Sterilization Validation Test	Sterility assurance level(106)for the recommended steamsterilization parameters ismet.	The recommended sterilizationparameters for the user arevalid.
Mechanical Test	Worst case test articles havepassed the pre-set criteria.	The subject devices have beenvalidated in mechanicalcharacteristics.
Cleaning Process ValidationTest	The subject devices showed lowbioburden level and metcriteria of 2.15 EU/device forendotoxin.	The cleaning process at themanufacturing sites has beenvalidated.
Packaging Validation Test	Final packaging of the subjectdevice has passed the testing forits complete sealing.	The subject device will be wellprotected until use in itspackaging.

The following bench tests have been performed on the subject device and passed the pre-set criteria.

9. Conclusion

Based on the non-clinical testing data and the information provided in the submission, we have concluded that our devices are substantially equivalent to the predicate devices in the market. No new questions of safety and effectiveness have been raised.

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).