The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with:
· degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),

· spondylolisthesis,
· trauma (i.e. fractures or dislocations),
tumors,
· deformity (defined as kyphosis, lordosis, or scoliosis),
· pseudoarthrosis.
· failed previous fusion,
· spinal stenosis.

Device Description

The CastleLoc-P Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6AI-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, four-level, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are self-tapping and self-drilling threaded. This device can be provided both as non-sterile and sterile.

AI/ML Overview

This document describes the premarket notification for the CastleLoc-P Anterior Cervical Plate System. It is a Special 510(k) submission to add new components to an already cleared device (K143271). Therefore, the provided information does not contain the typical details about acceptance criteria and comprehensive study results for an AI/ML medical device. In this case, the acceptance criteria are based on mechanical performance equivalence to a previously cleared device.

Based on the provided text, here's an analysis of the acceptance criteria and the "study" (mechanical performance testing) proving the device meets them:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (What needs to be shown)	Reported Device Performance (How it was shown)
Material: Same as predicate device (Titanium alloy Ti-6AI-4V ELI (ASTM F136)).	Confirmed: The new components are made from titanium alloy Ti-6AI-4V ELI (ASTM F136), identical to the predicate device.
Design: Same as predicate device (plates, screws, and lockers, with similar dimensions and configurations).	Confirmed: "The systems have the same design... The only difference is that there are additional components which use different sterilization method (gamma sterilization)." This implies the design itself of the new components is consistent with the previously cleared design.
Scientific Technology: Same as predicate device.	Confirmed: "The systems have the same... scientific technology..." This broadly indicates the fundamental principles of fixation are unchanged.
Indications for Use: Consistent with the predicate device.	Confirmed: The stated "Indications for Use" for the new components are identical to those of the predicate device (K143271).
Sterilization Method (New Component Specific): Performance is not adversely affected by the new gamma sterilization method.	Rationale Provided: "A rationale was provided as to why gamma sterilization does not affect the performance of the device. They are the same product in all aspect, except sterilization method." (The specific rationale itself is not detailed in this document but was submitted to the FDA.)
Mechanical Performance: Equivalent to the legally marketed unmodified device (K143271). Specifically, meeting standards for: - Static compression - Static torsion - Static tension - Fatigue strength.	Demonstrated by Substitution: "Mechanical performance of additional components are the same with the legally marketed device (unmodified) CastleLoc-P Anterior Cervical Plate System (K143271). Therefore, we substitute mechanical test data of additional components of CastleLoc-P Anterior Cervical Plate System with the one of unmodified device (K143271)." The original tests were conducted according to ASTM F1717.
Overall Equivalence: As safe, as effective, and performs as well as the predicate device.	Conclusion Stated: "The additional components of CastleLoc-P Anterior Cervical Plate System are as safe, as effective and perform as well as the predicate device. Therefore, the additional components of CastleLoc-P Anterior Cervical Plate System are substantially equivalent to the predicate device (K143271)."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample Size: Not explicitly stated as a number of devices or units. The "test set" here refers to the mechanical testing performed on the original cleared device (K143271). The submission substitutes this existing data for the new components. For mechanical testing of medical devices, specific sample sizes are typically defined by the relevant ASTM standards (e.g., ASTM F1717).
Data Provenance: Not explicitly stated through location or retrospective/prospective. The data is from mechanical testing of the primary predicate device (K143271).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This is not applicable for this type of submission. This device is a mechanical implant, not an AI/ML diagnostic tool. Ground truth is established through engineering and biomechanical testing standards (ASTM F1717), not expert interpretation of medical images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. See point 3.

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 not an AI/ML device, so no human reader studies were performed.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for this device's performance is defined by biomechanical engineering standards (ASTM F1717), which establish the minimum mechanical properties (strength, fatigue life, etc.) required for such an implant. Compliance with these standards is the "truth" that determines acceptable performance.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. See point 8.

Summary

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March 21, 2019

L&K BIOMED Co., Ltd. Ms. Jihyeon Seo Regulatory Affairs Associate #201, #202 16-25, Dongbaekjungang-ro 16 beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 17015 KOREA

Re: K190425

Trade/Device Name: CastleLoc-P Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 20, 2019 Received: February 22, 2019

Dear Ms. Seo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -S

for 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

510(k) Number (if known) K190425

Device Name

CastleLoc-P Anterior Cervical Plate System

Indications for Use (Describe)

· degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies),

· spondylolisthesis,
· trauma (i.e. fractures or dislocations),
tumors,
· deformity (defined as kyphosis, lordosis, or scoliosis),
· pseudoarthrosis.
· failed previous fusion,
· spinal stenosis.

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)

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510(k) SUMMARY

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

Submitter: 1. L&K BIOMED Co., Ltd. #201, #202 16-25, Dongbaekjungang-ro 16 beon-qil Giheung-gu, Yongin-si, Gyeonggi-do, 17015, Korea Phone: 82-2-6717-1983 e-mail: kate.seo@lnkbiomed.com Contact Person: Jihyeon Seo Date prepared February 20th, 2019

Device Identification 2.

Trade Name	CastleLoc-P Anterior Cervical Plate System
Regulatory Class	Class II
Regulation Name/Common Name	Anterior Cervical Plate
Classification Name	Spinal Intervertebral Body Fixation Orthosis(21 CFR888.3060)
Panel	Orthopedic
Product Code	KWQ

Purpose of 510(k) 3.

L&K BIOMED Co. Ltd., is submitting this Special 510(k) to add new components to own 510(k)-cleared device (K143271)

The name of the legally marketed (unmodified) device 4.

■ K143271 CastleLoc-P Anterior Cervical Plate System (primary predicate)

Description of the Device 5.

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Indication for Use 6.

The Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:

degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis, ●
0 trauma (i.e. fractures or dislocations),
O tumors,
0 deformity (defined as kyphosis, lordosis, or scoliosis),
pseudoarthrosis,
failed previous fusion, ●
spinal stenosis.

Comparison of the technological characteristics of the subject and 7. predicate devices

The new components of the CastleLoc-P Anterior Cervical Plate System are considered substantially equivalent to the referenced device (K143271). The systems have the same design, material, scientific technology, and indications for use. The only difference is that there are additional components which use different sterilization method (gamma sterilization).

A rationale was provided as to why gamma sterilization does not affect the performance of the device. They are the same product in all aspect, except sterilization method.

Performance Testing 8.

Mechanical performance of additional components are the same with the legally marketed device (unmodified) CastleLoc-P Anterior Cervical Plate System

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(K143271). Therefore, we substitute mechanical test data of additional components of CastleLoc-P Anterior Cervical Plate System with the one of unmodified device (K143271).

The CastleLoc-P Anterior Cervical Plate System was tested according to ASTM F1717, specifically, Static compression test, Static torsion test, Static tension test and fatigue test.

Conclusion 9.

The additional components of CastleLoc-P Anterior Cervical Plate System are as safe, as effective and perform as well as the predicate device. Therefore, the additional components of CastleLoc-P Anterior Cervical Plate System are substantially equivalent to the predicate device (K143271).

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.