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

The LeForte Neuro system bone screw is made of Titanium alloy (ASTM F136) and consists of common bone screw, self-drilling screw (auto screw & NS auto screw). The common bone screws are classified to 4 classes: Micro screw, Mini screw, Mini screw, Maxi screw. And the auto screws (self-drilling screws) are divided to 3 classes; Micro auto, Mini auto screws. Additionally, the NS auto screws are divided to 2 classes. This device is manufactured and intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; selective orthognathic surgery of the maxilla and chin.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the LeForte Neuro System Bone Screw.

Based on the provided 510(k) summary, this document is a premarket notification for a new medical device, the LeForte Neuro System Bone Screw. For 510(k) submissions, the primary method for demonstrating safety and effectiveness is to show substantial equivalence to a predicate device already legally marketed. This typically does not involve conducting a new clinical study with acceptance criteria in the same way one might for a PMA (Pre-Market Approval) submission. Instead, the focus is on comparing the new device to existing ones based on design, materials, intended use, and performance characteristics.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with specific performance endpoints is not directly applicable here. The "study" done is a comparative analysis demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for substantial equivalence, the "acceptance criteria" are not quantitative performance metrics in a clinical study but rather a demonstration that the new device is as safe and effective as the predicate devices. The performance is demonstrated by comparing its characteristics to those of the predicate devices.

Acceptance Criteria (Demonstration of Substantial Equivalence)	Reported Device Performance (LeForte Neuro System Bone Screw)
Intended Use (Same as predicate)	Intended for use in selective trauma of the mid-face and craniofacial skeleton; craniofacial surgery; reconstructive procedures; selective orthognathic surgery of the maxilla and chin.
Technological Characteristics (Similar to predicate)	Made of Titanium alloy (ASTM F136). Consists of common bone screws (Micro, Mini, Mini, Maxi) and self-drilling screws (Micro auto, Mini auto). Similar dimensions and characteristics to predicate.
Material (Same as predicate)	Titanium Alloy (ASTM F136)
Safety and Effectiveness (As safe and effective as predicate)	Potential adverse effects are identical to those of the predicate device. Manufactured using state-of-the-art technology, complying with MDD(93/42/EEC) and ISO 14630:1997.
Classification (Same as predicate)	Class II (21 CFR 872.4880) - Screw, Fixation, Intraosseous
Single Use (Same as predicate)	Single Use

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

For a 510(k) submission based on substantial equivalence, there isn't a "test set" of clinical data in the traditional sense with a specific sample size. The evidence is primarily based on:

Engineering and Material Testing: While not explicitly detailed in the provided summary, such submissions typically include mechanical testing (e.g., tensile strength, fatigue testing, torque strength) of the device to ensure it meets relevant ASTM/ISO standards and performs comparably to or better than predicate devices. The "sample size" for these tests would refer to the number of devices tested, which isn't provided here.
Comparison to Predicate Devices: The "data" provenance is the information available about the predicate devices (Synthes (USA) 1.3mm Craniofacial Screws - K021850 and Synthes (USA) Neuro Plate & Screw System - K042365), which are already FDA-cleared and on the market. This is retrospective information from existing devices. The country of origin for the predicate devices (Synthes (USA)) indicates the US; the new device is from Jeil Medical Corporation in South Korea.

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

This is not applicable to a 510(k) substantial equivalence submission. Ground truth (e.g., clinical outcomes, imaging interpretations) from experts is typically part of a clinical trial for novel devices where substantial equivalence cannot be established through non-clinical means.

4. Adjudication Method for the Test Set

Not applicable to a 510(k) substantial equivalence submission, as there is no clinical test set requiring adjudication in this context.

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

No, an MRMC comparative effectiveness study was not done. These types of studies involve human readers evaluating cases, often with and without AI assistance, to measure diagnostic performance. This is typically relevant for diagnostic imaging devices, not for an intraosseous fixation screw.

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

Not applicable. The device is a mechanical bone screw, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in a 510(k) substantial equivalence submission is the established safety and effectiveness profile of the predicate devices. The new device's design, materials, and intended use are compared against these known, legally marketed predicates. This is implicitly based on:

Regulatory clearance: The predicate devices have already been found safe and effective by the FDA.
Material standards: Adherence to standards like ASTM F136 for titanium alloy.
Performance standards: Implicit mechanical performance expectations for bone screws.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of medical device submission. This term is relevant for machine learning algorithms.

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

Not applicable, as there is no training set for this device.

Summary

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K091686

Medical Corporatio

Extribit 5 510(k) Summary of Safety and Effectiveness

NOV 1 8 2009

Model: LeForte Neuro System Bone Screw (Various Models)

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
  রে, Device Information Proprietary/Trade Name: LeForte Neuro System Bone Screw Common/Usual Name: Bone Screw Classification Name: Screw, Fixation, Intraosseous Classification Product Code: DZL Device Class: Class II per regulation 21 CFR 872.4880
心.
【人】【 New or Modification
The application is intended for premarket notification of new medical device, LeForte Neuro System Bone Screw, for US market
్త. - 1.40 Tay Marketed Device
- Plate, Souc (Model: Synthes (USA) Neuro Plate and Screw System) manufactured by ・・
  ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ Synth > (USA) - K042365, Decision Date: 11/18/2004, JEY (Class II per regulation 21CRF 372.4760)

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1. Screw, Fixation, Intraosseous (Model: Synthes (USA) 1.3mm Craniofacial Screws) manufactured by Synthes (USA) - K021850, Decision Date: 06/10/2002, DZL (Class II per regulation 21CFR 872.4880)

Description of the Device 6.

7. Indications for Use (Intended Use)

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

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

1. · Poor bone formulation, Osteoporosis, Osteomyelitis, inhibited revascularization, or
infection can cause loosening, bending, cracking or fracture of the device or premature loss of .
ﻧ fixation with the bone, leading to nonunion.
1. Nonision or delayed union which may lead to breakage of the implant.
Migration, bending, fracture or loosening of the implant. 3)
Metal sensitivity, or allergic reaction to foreign body 4)
Decrease in bone density due to stress shielding 5)
1. Pain. discomfort, or abnormal sensation due to the presence of the device
Increased fibrous tissue.response around the facture site and/or the implant 7)
1. Necrosis of bone
ਰੇ) Inadequate healing

Apart from these adverse effects there are always possible complications of any surgical procedure

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such as, but not limited to, infection, nerve damage and pain which may not be related to the ...." implant. . -- --

K091686

Safety and Effectiveness Comparison to Predicate Devices റ്റ.

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Device Name	Leforte Neuro SystemBone Screw (New)	Synthes(USA) 1.3mmCraniofacial Screws(K021850)	Synthes(USA) NeuroPlate & Screw System(K042365)
Applicant	Jeil Medical Corporation	Synthes(USA)	Synthes(USA)
Classification	Screw, Fixation,Intraosseous(Class II, 21 CFR 872.4880)	Screw, Fixation,Intraosseous (Class II21 CFR 872.4880)	Intraosseous fixationscrew or wire (Class II,21 CFR 872. 4880)Bone Plate(Class II, 21 CFR 872.4760)Burr hole cover(Class II, 21 CFR 882.5250)
Material	Titanium Alloy	Titanium Alloy	Titanium Alloy
Intended Use	This device is intended foruse in selective trauma ofthemid-face and craniofacialskeleton;craniofacial surgery:Reconstructive procedures;selective orthognathicsurgery of the maxilla andchin;	This device is intended foruse in selective trauma ofthe mid-face andcraniofacial skeleton;craniofacial surgery;reconstructive procedures;and selective orthognathicsurgery of the maxilla andchin.	This device is intendedfor use in selectivetrauma of the mid-faceand craniofacialSkeleton; craniofacialsurgery; reconstructiveprocedures;andselectiveorthognathic surgery ofthemaxilla and chin.
Single Use	Single Use	Single Use	Single Use

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Conclusion and in and System Bone Screws 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 is manufactured from material of titanium alloy (ASTM F136) that is used generally in this kind of bone screw. Similar devices made from titanium alloy (ASTM F136) to this device are manufactured and sold around the world. This device, LeForte Neuro system bone screw is substantially equivalent in design, material, and function to the products on the table above. These devices are certificated by notified body for CE.

. No ﺗﻨ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 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

NOV 1 3 2009

Re: K091686

Trade/Device Name: LeForte Neuro System Bone Screw (Various Models) Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw or Wire Regulatory Class: II Product Code: DZL Dated: October 19, 2009 Received: October 21, 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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Exhibit 4 Indications for Use

510(k) number (if known): _

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

Indications for Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ken Mulin for M SR
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091686

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.