This device is intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.

Device Description

LeForte Neuro System Bone Plate is made of unalloyed titanium (ASTM F67) and is manufactured and intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin. Jeil Medical Corporation utilizes the state of the art technology and apply the essential requirement of MDD(93/42/EEC) and ISO 14630:1997 from the device design to manufacturing and QC.

AI/ML Overview

The provided text is a 510(k) summary for the Jeil Medical Corporation's "LeForte Neuro System Bone Plate." This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of its performance against specific acceptance criteria in the manner of a clinical trial for an AI/software device.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training sets is not applicable to this document. The LeForte Neuro System Bone Plate is a physical medical device (bone plate) made of titanium, not an AI or software device.

The "study" presented here is a comparison to a predicate device to establish substantial equivalence, which is a regulatory pathway for physical devices.

Here's a breakdown of what is available in the provided text in relation to your prompt, and why specific points are not applicable:

1. Table of acceptance criteria and the reported device performance:

Not Applicable in the context of an AI/software device study. This document doesn't present performance metrics against specific quantitative acceptance criteria like sensitivity or specificity.
Instead, the "performance" is demonstrated by showing similarity in material, dimensions, characteristics, and intended use to the predicate device.

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

Not Applicable. There is no "test set" in the context of an AI/software device study described here. The evaluation is based on the device's design, materials, and intended use, compared to an already-approved predicate device.

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

Not Applicable. "Ground truth" from experts for a physical bone plate isn't established in the way it would be for an AI diagnostic device. The "truth" here is based on engineering specifications and clinical consensus on the function of such devices.

4. Adjudication method for the test set:

Not Applicable. No test set requiring adjudication in the context of AI/software device evaluation.

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 physical bone plate, not an AI-assisted diagnostic tool for human readers.

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

Not Applicable. This is not an algorithm or software.

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

Not Applicable in the AI/software sense. The "truth" for this device is its adherence to material standards (ASTM F67 for unalloyed titanium), manufacturing quality according to MDD(93/42/EEC) and ISO 14630:1997, and its functional equivalence to the predicate device.

8. The sample size for the training set:

Not Applicable. No training set exists for a physical hardware device like a bone plate.

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

Not Applicable. No training set.

Summary of the Device and its "Acceptance" (Regulatory Equivalence):

The LeForte Neuro System Bone Plate is deemed acceptable by the FDA through the 510(k) pathway by demonstrating "Substantial Equivalence" to a legally marketed predicate device.

Predicate Device: Synthes (USA) Neuro Plate and Screw System (K042365)

Table of Comparison (Regulatory "Acceptance Criteria" for Substantial Equivalence):

Feature	LeForte Neuro System Bone Plate	Predicate Device (Synthes Neuro Plate & Screw System)	"Acceptance" (Equivalence)
Material	Titanium (ASTM F67)	Titanium, Titanium Alloy	Equivalent
Intended Use	Selective trauma of mid-face, craniofacial skeleton, craniofacial surgery, reconstructive procedures, orthognathic surgery of maxilla and chin	Selective trauma of mid-face, craniofacial skeleton, craniofacial surgery, reconstructive procedures, orthognathic surgery of maxilla and chin	Identical
Single Use	Single Use	Single Use	Identical
Sterile	Non-sterile	Non-sterile	Identical
Classification	Class II, 21 CFR 872.4760 (Bone Plate)	Class II, 21 CFR 872.4760 (Bone Plate), etc.	Equivalent
Potential Adverse Affects & Complications	Listed in Section 8 (e.g., poor bone formation, migration, metal sensitivity, nonunion)	Common to all devices of this type	Identical
Manufacturing Standards	MDD(93/42/EEC) and ISO 14630:1997 (internal quality control)	Implied by regulatory approval (K042365)	Implied Equivalence

Conclusion from the 510(k) Summary (Page 2):
"In all respects, the LeForte Neuro System Bone Plates are the equivalent of currently marketed devices. They are made of the same materials and have similar dimensions and characteristics. Potential adverse effects are identical to those of the predicate device."

The Study that Proves Acceptance Criteria:

The "study" is the 510(k) premarket notification process itself, which relies on demonstrating the LeForte Neuro System Bone Plate is substantially equivalent to the predicate device. This is achieved by:

Engineering Comparison: Directly comparing the materials (unalloyed titanium), intended use, single-use status, sterility, and classification to the predicate device.
Risk Analysis: Stating that the potential adverse effects and complications are identical to those of the predicate device and common to all devices of this type.
Manufacturing Quality: Jeil Medical Corporation states it "utilizes the state of the art technology and apply the essential requirement of MDD(93/42/EEC) and ISO 14630:1997 from the device design to manufacturing and QC." While not a clinical study, this indicates adherence to recognized quality system standards.

In essence, the device "meets the acceptance criteria" because its characteristics, as detailed in the submission, are found by the FDA to be sufficiently similar to a previously cleared device, indicating that it is as safe and effective.

Summary

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K091679

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OCT - 2 2009

1 5

Exhibit 5 510(k) Summary of Safety and Effectiveness

Model: LeForte Neuro System Bone Plate

Submitter and US Official Correspondent
Submitter:	Jeil Medical Corporation
Address:	#702, Kolon Science Valley 2nd
	811, Guro-dong, Guro-gu
	Seoul, 152-050, Korea
Official Correspondent:	Shin Kuk Yoo, Consultant
Telephone No.:	714-313-7442
Fax No.:	801-303-7455
Email:	skyone@LSKBioPartners.com

1. Establishment Registration Number 3004049923

3. Device Information

Proprietary/Trade Name:	LeForte Neuro System Bone Plate
Common/Usual Name:	Bone Plate
Classification Name:	Plate, Bone
Classification Product Code:	JEY
Device Class:	Class II per regulation 21 CFR 872.4760

4. New or Modification

The application is intended for premarket notification of new medical device, LeForte Neuro System Bone Plate, for US market.

ડ. Equivalent Legally Marketed Deyice

1. Plate, Bone (Model: Synthes (USA) Neuro Plate and Screw System) manufactured by Synthes (USA) - K042365, Decision Date: 11/18/2004, JEY (Class II per regulation 21CRF 872.4760)

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Ko91679

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Description of the Device

7. Indications for Use (Intended Use)

8. Potential Adverse Affects and Complications (Common to all devices of this type)

l) Poor bone formulation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection can cause loosening, bending, cracking or fracture of the device or premature loss of fixation with the bone, leading to nonunion.
Nonunion or delayed union which may lead to breakage of the implant. 2)
1. Migration, bending, fracture or loosening of the implant.
1. Metal sensitivity, or allergic reaction to foreign body
1. Decrease in bone density due to stress shielding
1. Pain, discomfort, or abnormal sensation due to the presence of the device
1. Increased fibrous tissue response around the facture site and/or the implant
1. Necrosis of bone
1. Inadequate healing

Apart from these adverse effects there are always possible complications of any surgical procedure such as but not limited to, infection, nerve damage and pain which may not be related to the implant.

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K09 1679

Safety and Effectiveness, comparison to Predicate device
Device Name	LeForte Neuro System Bone Plate	Synthes(USA) Neuro Plate & Screw System
Applicant	Jeil Medical Corporation	Synthes(USA)
510(k)Number	New	K042365
Classification	Plate, Bone(Class II, 21 CFR 872. 4760)	Bone Plate(Class II, 21 CFR 872. 4760)Burr hole cover(Class II, 21 CFR 882. 5250)Intraosseous fixation screw or wire(Class II, 21 CFR 872. 4880)
Material	Titanium	TitaniumTitanium Alloy
Intended Use	This device is intended for use in selectivetrauma of the mid-face and craniofacialskeleton; craniofacial surgery;reconstructive procedures; and selectiveorthognathic surgery of the maxilla andchin.	This device is intended for use in selectivetrauma of the mid-face and craniofacialSkeleton; craniofacial surgery;reconstructive procedures; and selectiveorthognathic surgery of the maxilla andchin.
Single use	Single Use	Single Use
Sterile	Non-sterile	Non-sterile

10. Conclusion

In all respects, the LeForte Neuro System Bone Plates are the equivalent of currently marketed devices. They are made of the same materials and have similar dimensions and characteristics. Potential adverse effects are identical to those of the predicate device.

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

Jeil Medical Corporation C/O Mr. Shin Kuk Yoo Manager LSK BioPartners, Incoporated 215 South State Street, Suite 100B Salt Lake City, Utah 84111

OCT - 2 2009

Re: K091679

Trade/Device Name: LeForte Neuro System Bone Plate (Various Models) Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: September 8, 2009 Received: September 10, 2009

Dear Mr. Yoo:

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.

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.

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Page 2- Mr. Yoo

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-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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K091679

Exhibit 4 Indications for Use

510(k) number (if known): _

Device Name: LeForte Neuro System Bone Plate (Various Models)

AND/OR

Indications for Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Mulvey Son M SR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Regulation Number and Section

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.