The LeForte Neuro System is designed for use in selective trauma of the craniofacial skeleton, craniofacial surgery and reconstructive procedures. The LeForte Neuro System consists of bone plates in a variety of shapes and sizes, bone screws to secure the plates, convenience kits of bone plates and bone screws, and accessories to assist in the operational procedures. The LeForte Neuro System Bone Plate & Screw is made of pure titanium (ASTM F67) and titanium Alloy (ASTM F136). It is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.

AI/ML Overview

The provided text describes the LeForte Neuro System Bone Plate & Screw, a medical device used in craniofacial surgery. The submission focuses on demonstrating substantial equivalence to a predicate device through performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria	Reported Device Performance
Plates	Tensile strength: over N150	All test data met pre-set criteria
Screws	Torsion: 0.20Nm	All test data met pre-set criteria
	Pull-out: 20N	All test data met pre-set criteria

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

The document does not explicitly state the specific sample sizes (number of plates and screws) used for the performance tests. The provenance of the data is that it was generated through laboratory testing of the "modified LeForte Neuro System plates" and "modified LeForte Neuro System bone screws." It does not mention country of origin or whether it was retrospective or prospective, as these are not relevant for benchtop mechanical testing.

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

Not applicable. The "ground truth" for this device, which is a mechanical implant, is based on pre-set engineering criteria and objective physical measurements (tensile strength, torsion, pull-out force), not expert clinical judgment.

4. Adjudication Method for the Test Set:

Not applicable. As the testing involves objective mechanical measurements against pre-defined numerical thresholds, there is no need for adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. This is a mechanical device, not an imaging or diagnostic AI tool. Therefore, an MRMC study is not relevant, and no effect size for human readers improving with AI assistance would be applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is not an algorithm or AI device; it is a physical medical implant. The performance assessment is standalone in the sense that the device's mechanical properties were tested independently.

7. The Type of Ground Truth Used:

The ground truth used for evaluating this device is objective engineering specifications and pre-defined mechanical thresholds. These thresholds (e.g., N150 for tensile strength, 0.20Nm for torsion, 20N for pull-out) represent the minimum performance required for the device to be considered safe and effective for its intended use.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" for physical medical devices of this type. Performance is evaluated through direct mechanical testing against established criteria, not through machine learning or algorithm training.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set. The "ground truth" (acceptance criteria) for the performance tests would have been established by engineering standards, industry best practices for similar devices, and potentially regulatory guidance for neurosurgical fixation systems.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92

Date: May 27, 2014

1. 510K Applicant / Submitter:

Jeil Medical Corporation 702.703.704.705.706.805.807.812-ho 55. Digital-ro 34-gil, Guro-gu, Seoul, 152-728. Republic of Korea Tel : +82-2-850-3524 Fax: +82-2-850-3525

2. Submission Contact Person

LK Consulting Group USA. Inc. 2651 E Chapman Ave Ste 110, Fullerton. CA 92831 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com

3. Device

Proprietary Name -LeForte Neuro System Bone Plate & Screw ·
. Common Name -Neuro Plating System
Classification Name Preformed Alterable Cranioplasty Plate: . Burr hole cover; Cranioplasty plate fastener

4. Predicate Device

LeForte Neuro System Bone Plate & Screw by Jeil Medical Corporation (K112812)

5. Product Codes:

GWO, GXR. HBW

6. Classification Regulation:

21CFR§882.5320 21CFR§882.5250 21CFR §882.5360

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7. Description:

8. Substantial Equivalence Discussion:

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 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.

	Subject Device	Unmodified (Predicate) Device
510K Number	GXR	K112812
Product Code	GWO, GRX, HBW	GWO. GRA HBW
Manufacturer	Jeil Medical Corporation	Jeil Medical Corporation
Indications for	This device is intended for use in	This device is intended for use in
Use	selective trauma of the cranial	sclective trauma of the cranial
	skeleton, cranial surgery and	skeleton, cranial surgery and
	reconstructive procedures.	reconstructive procedures.
Materials	Plate - CP Ti Gr. 1,2,3, and 4 (ASTM	Plate - CP Ti Gr. 1,2,3, and 4 (ASTM
	F7)	F7)
	Screw - Ti 6Al 4V ELI (ASTM	Screw - Ti 6Al 4V ELI (ASTM
	FI36)	E136)
Dimensions	Plate thickness 0.3mm~1.0mm	Plate thickness 0.3mm~0.6mm
	Screw Outer Dia. 1.4~1.8mm	Screw Outer Dia. 1.4~1.8mm
	Screw Length 2.2~5.0mm	Screw Length 2.2~5.0mm
Surface Treatment	Plate - Anodization	Plate - Anodization
	Screw - N/A	Screw - N/A
Sterilization	Non-Sterile	Non-Sterile
	(Steam sterilization by user using	(Steam sterilization by user)
	same parameters as the unmodified
	device)
Usage	Single Use	Single Use
Packaging	Polyethylene Zip Lock Pouch	Polyethylene Zip Lock Pouch
	Cardboard Box	Cardboard Box

9. Performance Tests:

The modified LeForte Neuro System plates were tested for tensile strength. All the test

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data met pre-set criteria (over N150).

The modified LeForte Neuro System bone screws were tested for torsion and pull out. All the test data met pre-set criteria (0.20Nom for torsion, 20N for pull out).

10. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Jeil Medical Corporation concludes that the LeForte Neuro System Bone Plate & Screw is safe and effective and substantially equivalent to the predicate device as described herein.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60S Silver Spring, MD 20993-0002

July 2, 2014

Jeil Medical Corporation % Ms. Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave, Ste. I I 0 Fullerton, California 92831

Re: K141452

Trade/Device Name: Leforte neuro system bone plate and screw Regulation Number: 21 CFR 882.5320 Regulation Name: Preformed Alterable Cranioplasty Plate Regulatory Class: Class II Product Code: GWO, GXR, HBW Dated: May 27, 2014 Received: June 2, 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Ms. Priscilla Chung

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 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 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,

Felipe Aquel -S

Carlos L. Peña, PhD, MS for Director

Division of Neurological and Physical Medicine Devices Office of Device Evaluation 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: December 31, 2013 See PRA Statement on fast page.

510(k) Number (if known)

K141452

Device Name LeForte Neuro System Bone Plate & Screw

Indications for Use (Describe)

This device 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)

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)

Date: Felipe 2014.07.02 Aquel -S 17:29:34 -04'00'

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).