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 in 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.95mm in lengths of 3.0 to 6.0mm. It is made of Ti-6Al-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.

Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The plate is 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.

The Neuro Plating System has two types of sterilization method; Neuro Plating System is non-sterile state packed in PE bag which must be sterilized before use and Neuro Plating System - Sterile Kit is provide sterile state with gamma sterilization packed in Tyvek and PET. Both are single use only.

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification for the Neuro Plating System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.

Therefore, much of the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not directly available or applicable in the context of this 510(k) summary. This document primarily relies on non-clinical (mechanical and sterilization) testing to show equivalence.

However, I can extract information related to non-clinical testing and the comparison to predicate devices, which serves as the "proof" for substantial equivalence in this regulatory context.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, there isn't a table of specific clinical "acceptance criteria" with numerical targets and reported clinical device performance. Instead, the "acceptance criteria" are implied by the performance of the predicate device, and the "reported device performance" refers to the non-clinical tests conducted on the subject device to show it is equivalent.

Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Subject Device)
Mechanical Performance: - Comparable bending strength - Comparable torsion strength - Comparable axial pullout strength	Non-clinical tests performed: - 4 Point Bending Test - Torsion Test & Axial Pullout Strength Test Rationale for equivalence: "The subject device's titanium grade is the same as the predicate device's, but the subject device is thicker than the predicate device. Therefore, the performance testing of the subject device is expected to be substantially equivalent to the predicate device." (This implies the subject device met or exceeded the predicate's performance in these tests, although specific numerical results are not provided in this summary.)
Sterilization Efficacy: - Achieves sterility for pre-sterilized kits - Compatibility with steam sterilization for non-sterile components	Non-clinical tests performed: - Packaging Process Validation Test (only Neuro Plating System - Sterile Kit) - Gamma Sterilization Validation (only Neuro Plating System - Sterile Kit) Rationale for equivalence: "Validation of sterilization parameters... of the subject device are supported by sterilization validation... as provided in the primary predicate K190811."
Biocompatibility: - Biocompatible materials and design, similar to predicate	Rationale for equivalence: "...biocompatibility of the subject device are supported by... biocompatibility testing as provided in the primary predicate K190811."
Shelf Life: - Maintained functionality and sterility over intended shelf life (for pre-sterilized kits)	Non-clinical tests performed: - Shelf life (only Neuro Plating System - Sterile Kit)

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

Sample Size for Test Set: Not specified in the provided summary. For mechanical tests, this would typically involve a specific number of samples for each test (e.g., n=5 or n=10 per test), but the exact numbers are not present.
Data Provenance: Not specified, but implied to be from laboratory testing conducted on device samples. Country of origin for testing is not stated. The data is "non-clinical" (bench testing), not patient data, so "retrospective or prospective" is not applicable.

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

This information is not applicable as the submission relies on non-clinical, laboratory bench testing (mechanical and sterilization) rather than clinical data requiring expert review or ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the submission relies on non-clinical, laboratory bench testing. Adjudication methods are typically relevant for clinical studies where subjective assessments or multiple interpretations of patient data might occur.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging aids or AI assistance where human readers interpret cases. The Neuro Plating System is a surgical implant, not a diagnostic tool.

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

No, a standalone (algorithm only) performance study was not done. This concept applies to AI/software as a medical device. The Neuro Plating System is a physical implant.

7. The Type of Ground Truth Used

Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For the non-clinical tests, the "ground truth" would be the engineering specifications and established acceptable performance limits (often derived from the predicate device or relevant ASTM standards). For example, a "ground truth" for the 4-point bending test would be a minimum bending force or deformation standard that the device must meet, typically aligned with or surpassing the predicate's performance.

8. The Sample Size for the Training Set

Not applicable. The Neuro Plating System is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

Not applicable. As above, there is no "training set" for this device.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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 % Sanglok Lee Manager Wise Company Inc. #507, #508, 166 Gasan digital 2-ro, Geumcheon-gu Seoul, 08507 Korea. South

Re: K210360

Trade/Device Name: Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models)

Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: December 9, 2021 Received: December 17, 2021

Dear Sanglok Lee:

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.

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

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 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-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 Advice (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 Adam Pierce 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) K210360

Device Name Neuro Plating System

Indications for Use (Describe)

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

X 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) Summary

Date: November 9, 2021

Applicant / Submitter: 1.

Osteonic Co., Ltd. 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1005Ho, 1201Ho, 1202Ho, 1206Ho 38, Digital-ro 29-gil, Guro-gu, Seoul, Korea (Postcode 08381) Tel : +82-2-6902-8400 Fax : +82-2-6902-8401

2. Submission Correspondent

Na Young, Kang 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1005Ho, 1201Ho, 1202Ho, 1206Ho 38, Digital-ro 29-gil, Guro-gu, Seoul, Korea Tel. +82-2-6902-8415 Fax. +82-2-6902-8401 Email: naykang@osteonic.com

3. Device:

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

4. Predicate devices:

Primary Predicate devices: K190811- Neuro Plating System by Osteonic Co., Ltd. .

5. Product Code & Regulation Number:

GWO, GXR, HBW (21CFR§882.5320, 21CFR§882.5250, 21CFR§882.5360)

6. Device Description:

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

7. Indication for use:

Neuro Plating 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 predicate devices and the subject 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 subject devices and predicate devices are substantially equivalent.

The following tests were performed:

▪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)

The subject device's titanium grade is the same as the predicate device's, but the subject device is thicker than the predicate device. Therefore, the performance testing of the subject device is expected to be substantially equivalent to the predicate device.

Validation of sterilization parameters and biocompatibility of the subject device are supported by sterilization validation and biocompatibility testing as provided in the primary predicate K190811.

9. Substantial Equivalence:

The subject device is 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. There might be slight differences in dimensions, shapes between the subject device and each predicate device, however, the information and the data of non-clinical testing such as mechanical testing and sterilization testing provided in this submission supports substantial equivalence to the predicate devices in safety and performance.

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

	Subject device	Predicate Device	Reference Device	Equivalence
Manufacturer	OSTEONIC Co., Ltd.	OSTEONIC Co., Ltd.	Stryker	-
Device Name	NEURO PLATING SYSTEM	NEURO PLATING SYSTEM	Stryker Universal Neuro 3 System	-
510(K) #	K210360	K190811	K131775	-
Class	2	2	2	Equivalent
Product Code	GWO, GXR, HBW	GWO, GXR, HBW	GWO, GXR, HBW	Equivalent
Intended Use	Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.	Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.	The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).	Equivalent
Material(Chemicalcomposition)	•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
SurfaceTreatment	• Plate: Anodizing• Screw: Anodizing	• Plate: Anodizing• Screw: Anodizing	• Plate: Anodizing• Screw: Anodizing	Equivalent
Shape andDimension	Straight, angle, Y-shape, X-shape, D-Y shape, burr hole, square, matrix and mesh plate with various lengths and thickness (0.1 to 0.6mm). The screws range in diameters of 0.8 to 1.95mm and lengths from 3.0 to 6.0mm.	Straight, angle, Y-shape, X-shape, D-Y shape, burr hole, square, matrix and mesh plate with various lengths and thickness (0.1 to 0.6mm). The screws range in diameters of 0.8 to 1.95mm and lengths from 3.0 to 6.0mm.	Performed alterable cranioplasty plate, burr hole cover, cranioplasty plate fastener.	The safety and performance of plates and screws were shown to be equivalent to predicate device. - Most of components (plates and screws) of the model added this time are the same as the predicate device except for the plate_NST306X02A. The equivalence of NST306X02A with predicate device was verified.
Single Use	YES	YES	YES	Equivalent
Sterile	Neuro Plating System:Non sterile, steamsterilization before useNeuro Plating SystemSterile Kit : sterile,gamma irradiation	Neuro Plating System:Non sterile, steamsterilization before useNeuro Plating SystemSterile Kit : sterile,gamma irradiation	Sterile, gammairradiation	Equivalent

{6}------------------------------------------------

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 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).