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 prior to 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

The provided text describes the LnK Cervical Interbody Fusion Cage System and its 510(k) submission (K143360) to the FDA. This document is a premarket notification for a medical device, specifically an intervertebral body fusion device, which falls under Class II.

It's important to understand that a 510(k) submission, especially for a Class II device like this, typically focuses on demonstrating substantial equivalence to a previously legally marketed predicate device rather than conducting extensive clinical trials or complex AI performance studies. Therefore, the information you're requesting regarding AI performance analysis, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance will not be found in this type of document. These are common components of submissions for devices with novel algorithms, AI/ML components, or higher risk classifications, which this device does not appear to have.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance testing to demonstrate the device's mechanical integrity and safety, comparing it to an existing predicate device.

Here's the breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the safety and performance standards of the predicate device and the relevant ASTM standards for interbody fusion devices. The reported device performance is a declaration of equivalence and testing according to these standards.

Acceptance Criteria (Implicit)	Reported Device Performance and Basis for Equivalence
Material Composition: Use of biocompatible and mechanically sound materials.	The device uses PEEK-OPTIMA® LTI with marker pins made of Unalloyed Tantalum, identical to the predicate device.
Mechanical Performance: Meets established standards for spinal interbody fusion devices.	Mechanical performance of the additional components is stated to be the same as the predicated LnK Cervical Interbody Fusion Cage System (K120840). The device was tested according to ASTM F 2077 (Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing, Expulsion Testing) and ASTM F 2267 (Static Subsidence testing under Axial Compression). The change in sterilization method (gamma irradiation) is stated as "not effect on mechanical performance." Therefore, mechanical test data of the predicate device (K120840) was substituted for these additional components.
Sterilization Method: Ensures sterility without compromising device integrity.	The sterilization method is gamma irradiation, following ISO 11137. This is a change from the predicate, but it's asserted not to affect mechanical performance.
Intended Use and Indications: Consistent with established medical practice for similar devices.	Identical intended use and indications as the predicate device (K120840). Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C3 to C7), for fusion with autograft bone and supplemental fixation, after 6 weeks of non-operative treatment.
Design and Features: Functionally equivalent to a legally marketed predicate device.	The device is described as "same product in all aspect, except sterilization" compared to the predicate device (K120840). Available in a variety of sizes and configurations identical to the predicate.

Non-AI / Non-Algorithm-Based Information from the Document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document describes performance based on mechanical testing of the physical device components according to ASTM standards, not clinical patient data or data sets for an algorithm. Therefore, "sample size for the test set" would refer to the number of physical devices or components tested, which is not specified but would be dictated by the ASTM standards.
- Data provenance: Not applicable in the sense of patient data. The mechanical tests are laboratory-based.
- Retrospective or prospective: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for an AI/algorithm is not being established here. The "truth" is whether the physical device meets mechanical performance specifications, which is determined by objective physical measurements according to validated test methods (ASTM standards), not expert interpretation of outputs.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is relevant for clinical outcome adjudication or image interpretation, not mechanical testing of physical implants.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a physical implant, not an AI-assisted diagnostic or therapeutic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance study was not done. This device does not contain an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the mechanical performance, the "ground truth" is defined by the validated and standardized mechanical testing protocols (ASTM F 2077 and ASTM F 2267) which establish the pass/fail criteria for various mechanical stresses (axial compression, shear, torsion, expulsion, subsidence).
The sample size for the training set:
- Not applicable. This device does not involve a training set for an algorithm.
How the ground truth for the training set was established:
- Not applicable.

In summary: The provided document is for a traditional medical implant, and the approval is based on demonstrating substantial equivalence to a predicate device through non-clinical performance (mechanical testing) and material and design comparisons, not AI/ML performance studies.

Summary

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April 3, 2015

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

L&K Biomed Co., Ltd. Ms. Yerim An #201, 202 16-25, Dongbaekjungang-ro 16 beon-gil Giheung-gu, Yongin-si Geyonggi-do, 446-916 Korea

Re: K143360

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: March 19, 2015 Received: March 23, 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

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Page 2 - Ms. Yerim An

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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/Resourcesfor You/Industry/default.htm. 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/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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K143360 Page 1 of 1

Indications for Use Statement

510(k) Number (if known): K143360 Device Name: LnK Cervical Interbody Fusion Cage System

Indications For Use:

Prescription Use (Part 21 CER801 Subpart D)

AND/OR

Over-The-Counter Use (21 CER801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (OED)

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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:	March 19, 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 body fusion device21 CFR 888.3080

Predicate or legally marketed devices which are substantially equivalent 3.

L&K BIOMED Co., Ltd: LnK Cervical Interbody Fusion Cage System(K120840) .

4. Description of the Device

5. Intended use

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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.

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	K120840
4	Product Code	ODP	ODP
5	Class	ClassII	ClassII
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

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

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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(K120840). They are same product in all aspect, except sterilization. Sterilization method is gamma irradiation which is following ISO 11137. It is widely known that gamma irradiation sterilization is not effect on mechanical performance. 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(K120840).

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.

8. Conclusion

The additional components of LnK Cervical Interbody Fusion Cage System is substantially equivalent to the device referenced above and is therefore safe and effective for its intended use.

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.