LnK Cervical Interbody Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LnK Cervical Interbody Fusion Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. LnK. Cervical Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

Device Description

LnK Cervical Interbody Fusion Cage System intended for use as an interbody fusion cage device and must be used with supplemental fixation. The devices are available in a variety of different sizes and configurations to accommodate anatomical variation in different vertebral levels and/or patient anatomy. The devices are made of PEEK-OPTIMA® LTI with marker pins made of Unalloyed Tantalum.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the "LnK Cervical Interbody Fusion Cage System." It is a submission to the FDA seeking clearance to market the device, arguing for substantial equivalence to a previously cleared predicate device. Therefore, the document describes a study that proves the device meets the acceptance criteria, but it does not present a typical "study" in the sense of a clinical trial with human subjects and statistical performance metrics like sensitivity, specificity, or AUC for a diagnostic AI device.

Instead, the "study" referred to here is a set of mechanical performance tests conducted to demonstrate the physical and structural integrity of the interbody fusion cage and its equivalence to a predicate device.

Here's an breakdown based on your request, with the caveat that the "device performance" in this context refers to mechanical properties, not diagnostic accuracy:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Standard)	Reported Device Performance (Reference to K143360)
ASTM F 2077: Static and Dynamic Axial Compression	Mechanical test data of K143360 is directly applicable due to similarity and FE analysis showing non-worse case.
ASTM F 2077: Static and Dynamic Compression-Shear Testing	Mechanical test data of K143360 is directly applicable due to similarity and FE analysis showing non-worse case.
ASTM F 2077: Static and Dynamic Torsion Testing	Mechanical test data of K143360 is directly applicable due to similarity and FE analysis showing non-worse case.
ASTM F 2077: Expulsion Testing	Mechanical test data of K143360 is directly applicable due to similarity and FE analysis showing non-worse case.
ASTM F 2267: Static Subsidence Testing under Axial Compression	Mechanical test data of K143360 is directly applicable due to similarity and FE analysis showing non-worse case.
Equivalence to Predicate Device (K143360)	Deemed substantially equivalent to K143360. The additional components (7° angle cages) are not worse case than the predicate's 0° angle components, as demonstrated through finite element (FE) analysis.

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

Sample Size: The document does not specify a numerical "sample size" in terms of individual devices tested for each mechanical test. However, it indicates that the "additional components" (the 7° angled cages) were compared to the already existing "LnK Cervical Interbody Fusion Cage System (K143360)".
Data Provenance: The mechanical test data (for K143360) would be from laboratory testing. The Finite Element (FE) analysis is a computational method. The country of origin for the data generation is not explicitly stated for the testing, but the manufacturer is L&K BIOMED Co., Ltd. in the Republic of Korea. The data is "retrospective" in the sense that existing test data from K143360 is being leveraged for the new submission.

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

This question is not applicable in the context of this device and submission. This is a mechanical device, not a diagnostic one requiring expert interpretation of images or patient data to establish ground truth. The "ground truth" here is adherence to mechanical standards specified by ASTM.

4. Adjudication Method for the Test Set

This question is not applicable. Mechanical tests for medical devices are typically pass/fail based on predetermined thresholds within the ASTM standards, not on human adjudication of ambiguous cases.

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

This question is not applicable as this is a mechanical interbody fusion cage, not an AI-powered diagnostic or assistive tool.

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

This question is not applicable as this is a mechanical interbody fusion cage, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the performance requirements and test methods outlined in the ASTM standards (ASTM F 2077 and ASTM F 2267). The device's mechanical performance is compared against these engineering standards. For the new components, their performance against these standards is established by showing they are not a "worse case" than the predicate device, which itself met these standards.

8. The Sample Size for the Training Set

This question is not applicable as this is a submission for a mechanical device, not a machine learning model that requires a training set. The "analogy" for a training set here would be the design and manufacturing processes that result in the device, and the testing of previous iterations or predicate devices.

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

This question is not applicable for the reasons stated above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, connected by flowing lines.

July 15, 2015

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

L&K Biomed Company, Limited Ms. Yerim An Regulatory Affairs Specialist #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si Gyeonggi-do, 446-916 Republic of Korea

Re: K151677

Trade/Device Name: LnK Cervical Interbody Fusion Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 19, 2015 Received: June 22, 2015

Dear Ms. An:

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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the quality systems (OS) 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,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K151677

Page 1 of 1

510(k) Number (if known) K151677

Device Name

LnK Cervical Interbody Fusion Cage System

Indications for Use (Describe)

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.

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510(k) SUMMARY

The following 510(k) summary is being submitted as required by 21 CFR 807.92:

1.	Submitter:	Gook Jin KangL&K BIOMED Co., Ltd.#201, 202 16-25, Dongbaekjungang-ro 16 beon-gilGiheung-gu, Yongin-si, Gyeonggi-do, 446-916,KoreaPhone. 82-2-6717-1985FAX.82-2-6717-1989
	Contact Person:	Yerim An
	Date prepared:	July 10, 2015

Device Identification 2.

Trade Name	LnK Cervical Interbody Fusion Cage System
Common Name	Intervertebral Body Fusion Device
Product Code	ODP
Classification	Class II
Classification Name	intervertebral fusion device with bone graft, cervica21 CFR 888.3080

Primary Predicate or legally marketed devices which are substantially equivalent 3.

• Primary Predicate:

L&K BIOMED Co., Ltd_LnK Cervical Interbody Fusion Cage System (K143360)

Description of the Device 4.

ട്. Intended use

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Cervical Interbody Fusion Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. LnK Cervical Interbody Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

		6. Comparison of the technology characteristics of the device to predicate and
legally marketed devices

No	Item	LnK Cervical InterbodyFusion Cage System	LnK Cervical InterbodyFusion Cage System(Predicate)
1	Manufacturer	L&K BIOMED Co., Ltd.	L&K BIOMED Co., Ltd.
2	Material	PEEK and Tantalum	PEEK and Tantalum
3	510(K) Number	-	K143360
4	Product Code	ODP	ODP
5	Class	ClassII	ClassIl
6	Intended Use	LnK Cervical InterbodyFusion Cage System isindicated for use in skeletallymature patients withdegenerative disc disease(DDD) of the cervical spinewith accompanying radicularsymptoms at one disc level.DDD is defined as discogenicpain with degeneration of thedisc confirmed by patienthistory and radiographicstudies. LnK CervicalInterbody Fusion CageSystem is used to facilitateintervertebral body fusion inthe cervical spine at the C3 toC7 disc levels using autograftbone. LnK Cervical InterbodyFusion Cage System is to beused with supplementalfixation. Patients should haveat least six (6) weeks of non-operative treatment prior totreatment with anintervertebral cage	LnK Cervical InterbodyFusion Cage System isindicated for use in skeletallymature patients withdegenerative disc disease(DDD) of the cervical spinewith accompanying radicularsymptoms at one disc level.DDD is defined as discogenicpain with degeneration of thedisc confirmed by patienthistory and radiographicstudies. LnK CervicalInterbody Fusion CageSystem is used to facilitateintervertebral body fusion inthe cervical spine at the C3 toC7 disc levels using autograftbone. LnK Cervical InterbodyFusion Cage System is to beused with supplementalfixation. Patients should haveat least six (6) weeks of non-operative treatment prior totreatment with anintervertebral cage

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Performance Data 7.

Mechanical performance of additional components of LnK Cervical Interbody Fusion Cage System is same with predicated LnK Cervical Interbody Fusion Cage System(K143360). They are same product in all aspect, except angle of cage. Predicate components have only 0° angle. The additional components have 7° angle. The additional components are not worse case as demonstrated through finite element (FE) analysis. Therefore, we substitute mechanical test data of additional components of LnK Cervical Interbody Fusion Cage System with it of LnK Cervical Interbody Fusion Cage System (K143360).

The LnK Cervical Interbody Fusion Cage System was tested according to the ASTM F 2077, specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing, Expulsion Testing and Static Subsidence testing under Axial Compression, per ASTM F 2267.

Conclusion 8.

The additional components of LnK Cervical Interbody Fusion Cage System are substantially equivalent to the device referenced above.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.