The Neuro Plating 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 comes in 3 anodized colors (silver, blue and gold). The screws range in diameter from 0.8mm to 1.95mm and in lengths of 3.0mm to 6.0mm. They are made of Ti- 6Al-4V ELI titanium alloy (ASTM F136) and come in 3 anodized colors (silver, green and gold).

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

The Neuro Plating System has two types of sterilization methods: 1.) the Neuro Plating System is non-sterile state packed in a PE bag which must be sterilized before use; and 2.) the Neuro Plating System - Sterile Kit is provided sterile using gamma sterilization packed in Tyvek and PET. Both are single use only.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the Optimus Neuro Plating System, and details its substantial equivalence to predicate devices. It does not present a study proving the device meets specific acceptance criteria in terms of AI or algorithm performance.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to regulatory acceptance for market clearance based on substantial equivalence to existing devices, rather than performance metrics for an AI-powered system or diagnostic accuracy study.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of submission.

Here's how the provided information relates to your request:

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

The document doesn't present "acceptance criteria" in the sense of performance metrics for an AI system. Instead, it presents a comparison table demonstrating the "substantial equivalence" of the modified device to its predicate devices across various attributes. The "performance" here refers to the device proving it is as safe and effective as the predicate, not a quantifiable clinical outcome or AI accuracy.

Table: Comparison of Modified Device to Predicate Devices for Substantial Equivalence

Feature/Criterion	Modified Device (Optimus Neuro Plating System) Performance/Description	Unmodified (Predicate) Device (K141911) Performance/Description	Unmodified (Predicate) Device (K183352) Performance/Description	Equivalence Outcome / "Acceptance"
Manufacturer	OSTEONIC Co., Ltd.	OSTEONIC Co., Ltd.	OSTEONIC Co., Ltd.	-
Device Name	NEURO PLATING SYSTEM	NEURO PLATING SYSTEM	NEURO PLATING SYSTEM	-
510(K) #	K190811	K141911	K183352	-
Class	2	2	2	Equivalent
Product Code	GWO, GRX, HBW	GWO, GRX, HBW	GWO, GRX, HBW	Equivalent
Intended Use	Intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.	Intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.	Intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.	Equivalent
Material (Chemical Composition)	Plate: Pure Titanium ASTM F67; Screw: Titanium Alloy ASTM F136	Plate: Pure Titanium ASTM F67; Screw: Titanium Alloy ASTM F136	Plate: Pure Titanium ASTM F67; Screw: Titanium Alloy ASTM F136	Equivalent
Surface Treatment	Plate: Anodized; Screw: Anodized	Plate: Anodized; Screw: Anodized	Plate: Anodized; Screw: Anodized	Equivalent
Shape and Dimension	Straight, burr hole with various lengths and thickness. Plate sizes: 0.3mm to 0.6mm thick. Screw diameter: 0.8mm to 1.95mm; lengths: 3.0mm to 6.0mm.	Straight, angle, Y-shape, X-shape, burr hole, square, matrix and mesh with various lengths and thickness. Plate: various length and thickness (0.1 to 0.6mm). Screw diameter: 0.8 to 1.8mm; lengths: 3.0 to 6.0mm.	D-Y Shape, Y-Shape, Burr hole Plate and mesh with various lengths and thickness (0.3 to 0.6mm).	Plates and screws were found to be substantially equivalent through 4 point bending testing, torsional testing, and axial pullout strength testing. The modified devices passed all testing.
Single Use	YES	YES	YES	Equivalent
Sterile	Neuro Plating System: Non sterile, steam sterilization before use. Neuro Plating System Sterile Kit: sterile, gamma irradiation.	Non sterile, steam sterilization before use.	Non sterile, steam sterilization before use.	Neuro Plating System - Sterile Kit (gamma irradiation) added. Plates and screws were evaluated through packaging process validation test, gamma sterilization validation and shelf life. The modified devices passed all testing.
Non-clinical tests performed on modified device	4 Point Bending Test, Torsion Test & Axial Pullout Strength Test, Packaging Process Validation Test (Sterile Kit only), Gamma Sterilization Validation (Sterile Kit only), Shelf life (Sterile Kit only), MR safety test. Test results demonstrated that the subject devices are substantially equivalent to the predicate devices.	Testing on predicate devices, by which the modified device was compared for substantial equivalence.	Testing on predicate devices, by which the modified device was compared for substantial equivalence.	"Test results demonstrated that the subject devices are substantially equivalent to the predicate devices." "overall higher than the predicate devices" (for some mechanical tests)

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

Test Set Description: The "test set" in this context refers to the samples of the physical device that underwent non-clinical laboratory testing (e.g., mechanical strength, sterilization validation).
Sample Size: The document does not specify the exact number of units used for each test (e.g., how many plates/screws for the 4-point bending test). It only states that "The following tests were performed on the modified devices."
Data Provenance: The tests were performed by Osteonic Co., Ltd. (the manufacturer) in South Korea. The data would be internally generated "non-clinical tests." The provenance typically refers to the source of the clinical data (e.g., patient records), which is not relevant here as this is a device clearance based on engineering and material testing. The tests are prospective as they were conducted for this submission.

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):

Not applicable. This submission is for a physical medical implant, not an AI or diagnostic imaging device that requires interpretation by medical experts to establish ground truth for performance evaluation. The "ground truth" for the device's characteristics (e.g., material strength, sterility) is established by standardized engineering tests and established quality control methods, not expert consensus on medical images.

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

Not applicable. This refers to a method used to resolve discrepancies in expert interpretations (e.g., for image annotations or diagnoses), which is not relevant to the non-clinical engineering and material tests performed for this device.

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 is a type of study performed for diagnostic AI tools to evaluate their impact on human interpretation. This submission is for a physical neuro plating system.

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

Not applicable. This describes the performance evaluation of an AI algorithm in isolation. The Optimus Neuro Plating System is a physical implant, not an algorithm.

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

For the physical device, the "ground truth" for demonstrating substantial equivalence is based on:
- Engineering specifications and standards: ASTM F67, ASTM F136, ISO 10993.
- Validated test methods: 4 Point Bending Test, Torsion Test, Axial Pullout Strength Test, Packaging Process Validation Test, Gamma Sterilization Validation, Shelf life, MR safety tests.
- Comparison to predicate device performance data in these established physical and biological safety metrics.

8. The sample size for the training set:

Not applicable. This is relevant for AI/ML models. This document describes a physical medical device.

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

Not applicable. Relevant for AI/ML models.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Osteonic Co., Ltd Choi Se Young Associate Manager Engineer 1206Ho 38 Digital-ro 29-gil, Guro-gu, Seoul, 08381 KR

Re: K190811

Trade/Device Name: Optimus Neuro Plating System Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: March 19, 2019 Received: March 29, 2019

Dear Choi Se Young:

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.

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

{1}------------------------------------------------

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-devices/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 Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K190811

Device Name

Optimus Neuro Plating System

Indications for Use (Describe)

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

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)

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 PRAStaff@fda.hhs.gov

"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."

{3}------------------------------------------------

510(k) Summarv

Date: November 25, 2019

1. Applicant / Submitter:

Osteonic Co., Ltd. 1206Ho 38 Digital-ro 29-gil, Guro-gu, Seoul, Korea (Postcode 08381) Tel : +82-2-6902-8415 Fax : +82-2-6902-8401

2. Submission Correspondent

Ji-Sun, Lee 1206Ho 38 Digital-ro 29-gil, Guro-gu, Seoul, Korea Tel. +82-2-6902-8400 Fax. +82-2-6902-8401 Email: jisun@osteonic.com

3. Device:

· Proprietary Name Optimus Neuro Plating System
Common Name Neuro Plating System
= Classification Name Preformed Alterable Cranioplasty Plate; Burr hole cover; Cranioplasty plate fastener

4. Predicate Devices:

Predicate devices: K183352- Neuro Plating System by Osteonic Co.,Ltd.
Predicate devices: K141911- Neuro Plating System by Osteonic Co.,Ltd.

Product Codes & Regulation Numbers: 5.

21 C.F.R. 882.5320 = GWO =
21 C.F.R 882.5250 ■ GRX
21 C.F.R. 882.5360 ■ HBW

6. Device Description:

{4}------------------------------------------------

Indication for use: 7.

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

8. Non-clinical tests:

There are a number of differences between the predicate devices and the modified devices as presented in this submission. The differences were evaluated through design controls, risk analysis and verification & validation activities. Test results demonstrated that the subject devices are substantially equivalent to the predicate devices.

The following tests were performed on the modified devices to demonstrate substantial equivalence to the predicate devices.

4 Point Bending Test
· Torsion Test & Axial Pullout Strength Test
Packaging Process Validation Test (only Neuro Plating System Sterile Kit)
Gamma Sterilization Validation (only Neuro Plating System Sterile Kit)
Shelf life (only Neuro Plating System Sterile Kit)
MR safety test

The test results of the modified devices were overall higher than the predicate devices demonstrating that the modified devices are substantially equivalent to the predicate devices.

Biocompatibility testing was conducted in accordance with ISO 10993.

9. Substantial Equivalence:

The modified devices are similar to the predicate devices in terms of indications, materials, use and design. All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices. Although there are slight differences in dimensions, shapes and sterility between the modified devices and the predicate devices, the information and the data of nonclinical testing such as mechanical testing and sterilization testing provided in this submission proves substantial equivalence to the predicate devices in safety and performance.

{5}------------------------------------------------

	Modified Device	Unmodified(Predicate) Device	Unmodified(Predicate) Device	Equivalence
Manufacturer	OSTEONIC Co., Ltd.	OSTEONIC Co., Ltd.	OSTEONIC Co., Ltd.	-
Device Name	NEURO PLATINGSYSTEM	NEURO PLATINGSYSTEM	NEURO PLATINGSYSTEM	-
510(K) #	K190811	K141911	K183352	-
Class	2	2	2	Equivalent
Product Code	GWO, GRX, HBW	GWO, GRX, HBW	GWO, GRX, HBW	Equivalent
Intended Use	Neuro Plating Systemis intended for use inselective trauma ofthe cranial skeleton,cranial surgery andreconstructiveprocedure.	Neuro Plating Systemis intended for use inselective trauma ofthe cranial skeleton,cranial surgery andreconstructiveprocedure.	Neuro Plating Systemis intended for use inselective trauma ofthe cranial skeleton,cranial surgery andreconstructiveprocedure.	Equivalent
Material(Chemicalcomposition)	•Plate- Pure TitaniumASTM F67•Screw- TitaniumAlloy ASTM F136	•Plate- Pure TitaniumASTM F67•Screw- TitaniumAlloy ASTM F136	•Plate- Pure TitaniumASTM F67•Screw- TitaniumAlloy ASTM F136	Equivalent
SurfaceTreatment	•Plate: Anodized•Screw: Anodized	•Plate: Anodized•Screw: Anodized	•Plate: Anodized•Screw: Anodized	Equivalent
Shape andDimension	Straight, burr hole withvarious lengths andthickness.The range of platesizes is from 0.3mmto 0.6mm thick. Thescrews range indiameter from 0.8mmto 1.95mm and inlengths of 3.0mm to6.0mm.	Straight, angle, Y-shape, X-shape, burrhole, square, matrixand mesh with variouslengths and thicknessPlate has variouslength and thickness(0.1 to 0.6mm). Thescrews range indiameters of 0.8 to1.8mm and lengthsfrom 3.0 to 6.0mm	D-Y Shape, Y-Shape,Burr hole Plate andmesh with variouslengths and thickness(0.3 to 0.6mm).	Plates and screwswere found to besubstantiallyequivalentthrough4 point bending testing,torsional testing, andaxial pullout strengthtesting. The modifieddevices passed alltesting
Single Use	YES	YES	YES	Equivalent
Sterile	Neuro Plating System: Non sterile, steamsterilization before useNeuro Plating SystemSterile Kit :sterile, gammairradiation	Non sterile, steamsterilization before use	Non sterile, steamsterilization before use	Neuro Plating System- Sterile Kit (gammairradiation) added.Plates and screwswere evaluatedthrough packagingprocess validationtest, gammasterilizationvalidation and shelflife. The modifieddevices passed alltesting.

10. Conclusions:

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

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).