4CIS® Marlin ACIF Cage System is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have six weeks of non-operative therapy. The 4CIS® Marlin ACIF Cage System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft, and is to be implanted via an open, anterior approach. It is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine, such as Anterior Cervical Plate system.

Device Description

4CIS® Marlin ACIF cages are hollow, generally rectangular box shape made either from poly-ether-ether-ketone [PEEK-OPTIMA® LT1 (Invibio, Inc., West Conshohocken, PA USA) / VESTAKEEP® i4R (Evonik Industries, Essen Germany)] or Titanium alloy according to ASTM F2026(PEEK), F136(64ELI), F560(Tantalum). The cages are available in a variety of sizes and geometric options to fit the anatomical needs of a wide variety of patients. The device is filled with a bone graft material and inserted into the intervertebral body space of the cervical spine through an anterior cervical approach. As the design requirements, this cage design maintains the spacing between two vertebral bones following discectomy until fusion occurs. Each PEEK cage has three(3) x-ray markers made of tantalum for ease of visualization on the radiographs. Angled shape for lordotic curve and anatomic shape is available to allow maximum preservation of bony endplate with this system and teeth on the surfaces ensure enough contact with bony endplate, which prevents subsidence of the cage into the vertebral body when the teeth increase the anchoring and prevent slipping or expulsion.

AI/ML Overview

This is a medical device 510(k) summary for the "4CIS® Marlin ACIF Cage System," an intervertebral body fusion device. The document describes the device, its intended use, and its comparison to predicate devices for substantial equivalence.

Here's an analysis of the provided text for acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for clinical performance usually seen in AI/software studies (e.g., sensitivity, specificity, AUC). Instead, it focuses on mechanical performance for this implantable device. The "Performance Specification" section states:

Acceptance Criterion (Implied)	Reported Device Performance
Equivalent Mechanical Performance to Predicate Devices under the same test conditions (for static and dynamic compression, static and dynamic torsion, static subsidence and static expulsion)	`4CIS® Marlin ACIF Cage System demonstrated equivalent performance to the cited predicate device under the same test conditions.`

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

This document describes a mechanical device, not an AI/software product requiring a "test set" of patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country, retrospective/prospective) are not applicable in the context of this medical device submission. The performance data comes from laboratory mechanical testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

As this is a mechanical device submission, there is no mention of experts establishing ground truth for a test set in the way it would be for an AI diagnostic algorithm. Ground truth here refers to the physical properties and performance of the device under mechanical stress, evaluated against established ASTM standards.

4. Adjudication Method for the Test Set

Again, this is not applicable as there is no "test set" in the context of clinical interpretation by experts. Mechanical testing results are objective measurements.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists reading images) and AI assistance. This submission pertains to an implantable surgical device.

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

Not Applicable. This is a physical intervertebral cage, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by Mechanical Testing Standards (ASTM F2077 and ASTM F2267). This involves objective measurements of physical properties like static and dynamic compression, torsion, subsidence, and expulsion, compared against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This isn't an AI model requiring a training set. The device's design and manufacturing processes are developed through engineering and material science, not machine learning training.

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

Not applicable. See point 8.

Summary

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

February 16, 2017

Solco Biomedical Co., Ltd. % Hwi Joon Park Manager First Gold Corp. 14110 Dallas Pkwy, Suite 135 Dallas, Texas 75254

Re: K162402

Trade/Device Name: 4CIS® Marlin ACIF Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 11, 2016 Received: January 17, 2017

Dear Mr. Park:

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,

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

510(k) Number (if known)

K162402

Device Name 4CIS® Marlin ACIF Cage System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CEB 801 Subpart D)
Over-The-Counter Use (21 CER 801 Subpart C)

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510(k) Summary

Submitter	Solco Biomedical Co., Ltd.154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do, 17704Republic of KoreaPhone. +82-31-664-4101Fax. +82-31-663-8983
Contact Person	HWI JOON, PARK14110 Dallas Pkwy Suite 135, Dallas, Texas 75254 USAPhone: +1-972-247-2486Fax: +1-972-247-2413
Submission Date	Aug 23, 2016
Trade / Proprietary name	4CIS® Marlin ACIF Cage System
Common / Usual Name	Cervical Intervertebral Body Fusion Device
Classification NameClassification CodeRegulatory ClassRegulation Number	Intervertebral Fusion Device With Bone Graft, CervicalODPClass II888.3080
Predicate Device	SYNTHES ACIS/VERTEBRAL SPACER CR(K120275, Primary)Endoskeleton® TC (K100889, Additional)PATRIOT SPACERS: COLONIAL ACDF(K072991, Additional)Phantom™ Plus (K082801, Additional)TRYPTIK Ca (K091873, Additional)The predicate devices have not been subject to a design related recall.
Description of Device	4CIS® Marlin ACIF cages are hollow, generally rectangular boxshape made either from poly-ether-ether-ketone [PEEK-OPTIMA®LT1 (Invibio, Inc., West Conshohocken, PA USA) / VESTAKEEP®i4R (Evonik Industries, Essen Germany)] or Titanium alloyaccording to ASTM F2026(PEEK), F136(64ELI), F560(Tantalum).The cages are available in a variety of sizes and geometric options to
	fit the anatomical needs of a wide variety of patients.
	The device is filled with a bone graft material and inserted into theintervertebral body space of the cervical spine through an anteriorcervical approach. As the design requirements, this cage designmaintains the spacing between two vertebral bones followingdiscectomy until fusion occurs.
	Each PEEK cage has three(3) x-ray markers made of tantalum forease of visualization on the radiographs.
	Angled shape for lordotic curve and anatomic shape is available toallow maximum preservation of bony endplate with this system andteeth on the surfaces ensure enough contact with bony endplate,which prevents subsidence of the cage into the vertebral body whenthe teeth increase the anchoring and prevent slipping or expulsion.
Indication for Use	4CIS® Marlin ACIF Cage System is indicated for use in cervicalintervertebral body fusion procedures in skeletally mature patients withdegenerative disc disease (DDD) at the levels from C2-C3 disc to theC7-T1 disc. DDD is defined as neck pain of discogenic origin withdegeneration of the disc confirmed by patient history and radiographicstudies. These patients should have six weeks of non-operative therapy.The 4CIS® Marlin ACIF Cage System is to be used with autogenousbone graft and/or allogenic bone graft comprised of cancellous and/orcorticocancellous bone graft, and is to be implanted via an open, anteriorapproach. It is intended to be used with supplemental spinal fixationsystems that have been cleared for use in the cervical spine, such asAnterior Cervical Plate system.
Comparison ofTechnologicalCharacteristics with thePredicate Devices	Indication for UseThe subject 4CIS® Marlin ACIF Cage System and all the predicateshave similar indications for use statements.
	MaterialsThe predicate subject device is composed of the same material as thepredicate devices have conforming to recognized industry standards forpermanent implants.
	Design Features/FunctionsThe subject 4CIS® Marlin ACIF Cage System and cited predicatedevices share similar basic design features and functions.
	DimensionsThe subject 4CIS® Marlin ACIF Cage System is dimensionally similarto cited predicate devices.
	SterilizationThe subject 4CIS® Marlin ACIF Cage System and cited predicatedevices are provided sterile and non-sterile for single use only.
	Performance Specification
	Mechanical testing confirmed 4CIS® Marlin ACIF Cage Systemdemonstrated equivalent performance to the cited predicate device underthe same test conditions.
Performance Data	Mechanical testing (static and dynamic compression, static and dynamictorsion, static subsidence and static expulsion) was conducted inaccordance with ASTM F2077, and ASTM F2267.Above non-clinical performance data in the form of a comprehensiveliterature review was provided in support of substantial equivalence ofthe subject device.
Conclusion	Based on the provided performance data, the subject device issubstantially equivalent to the referenced predicate devices.

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K162402

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K162402 Page 3 of 3

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.