4CIS® Marlin PEEK ACIF Cage is indicated for use in cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at the levels from the 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 in advance. The 4CIS® Marlin PEEK ACIF Cage is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous 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 PEEK ACIF Cage is single component devices used to restore height of disc space by anterior approach and to facilitate cervical interbody fusion with maintaining physiological lordotic angulation of cervical spine. To allow maximum preservation and ensure ample contact surfaces with bony endplate, a variety of shapes and sizes are available and each device has three tantalum markers for ease of visualization on radiographs. The vertical square teeth on the top and the bottom surface prevent subsidence of the cage into the vertebral body while they increase the anchoring and prevent slipping or expulsion. To make solid fusion of intervertebral body, hollow space in the implant allows bone graft material to be filled. The implant has safety proven structure and material (Poly-ether-ether-ketone, ASTM F2026) to promote biological synostosis and assures mechanical safety against load.

AI/ML Overview

This FDA 510(k) summary describes a medical device, the 4CIS® Marlin PEEK ACIF Cage, which is an intervertebral body fusion device. The provided text is a regulatory filing for this device and does not contain information about software or AI performance metrics. Therefore, it is not possible to answer your questions regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these pertain to the evaluation of AI/software device performance, which is not discussed in this document.

The document focuses on demonstrating substantial equivalence of the physical implant device to predicate devices through mechanical testing and comparison of characteristics.

Here's a breakdown of the information that is present and why your specific questions about AI/software performance cannot be answered from this text:

Information Present in the Document:

Device Name: 4CIS® Marlin PEEK ACIF Cage
Intended Use: Cervical intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at specific cervical levels (C2-C3 disc to C7-T1 disc). It is to be used with bone graft and supplemental spinal fixation systems.
Material: Poly-ether-ether-ketone (PEEK), conforming to ASTM F2026.
Design Features: Single component, designed to restore disc height, facilitate fusion, maintain lordotic angulation, various shapes/sizes, three tantalum markers for visualization, vertical square teeth to prevent subsidence and aid anchoring, hollow space for bone graft.
Predicate Devices: 4CIS® Marlin ACIF Cage System (K162402) as primary; PATRIOT SPACERS: COLONIAL ACDF (K072991), TRYPTIK Ca (K091873), MATISSE Anterior Cervical Interbody Fusion Cage System (K162682) as additional.
Performance Data (Non-Clinical): Mechanical testing was conducted in accordance with ASTM F2077-17 and F2267-04. This included static axial compression, static compression-shear, static torsion, dynamic axial compression, dynamic compression-shear, dynamic torsion, and static subsidence.
Conclusion: The device is substantially equivalent to legally marketed predicate devices based on overall technology characteristics and mechanical performance data.

Why Your Questions Cannot Be Answered from This Document:

Your questions pertain to the evaluation of AI or software-based medical devices. The 4CIS® Marlin PEEK ACIF Cage is a physical medical implant, not a software or AI device. Therefore, the concept of "acceptance criteria" in the context of AI performance, "test set," "training set," "ground truth," "experts for ground truth," "adjudication," or "MRMC studies" as they relate to AI algorithms simply do not apply to this regulatory filing. The "performance data" mentioned refers solely to the biomechanical properties of the physical implant.

Summary

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December 19, 2019

Solco Biomedical Co., Ltd. Hwi-Geun Yu RA & Exam Certification Team Leader 154 Seotan-ro, Seotan-myeon Pyeongtaek-Si, Gyeonggi-do, 17704 Republic of Korea

Re: K192044

Trade/Device Name: 4CIS Marlin PEEK ACIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: November 29, 2019 Received: December 4, 2019

Dear Hwi-Geun Yu:

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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Brent L. Showalter, PhD DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

K192044

Device Name

4CIS® Marlin PEEK ACIF Cage

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)

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510(k) Summary

Submitter	Solco Biomedical Co., Ltd.154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do,17704 Republic of KoreaPhone. +82-31-664-4101Fax. +82-31-663-8983
Contact Person	Hwi-geun YuSolco Biomedical Co., Ltd.154 Seotan-ro, Seotan-myeon, Pyeongtaek, Gyeonggi-do,17704 Republic of KoreaPhone: +82-31-610-4091Fax: +82-31-663-8983
Preparation Date	July 22, 2019
Trade / Proprietary name	4CIS® Marlin PEEK ACIF Cage
Common / Usual Name	Cervical Intervertebral Body Fusion Device
Classification NameClassification CodeRegulatory ClassRegulation Number	Intervertebral Fusion Device With Bone Graft, CervicalODPClass II888.3080
Predicate Device	4CIS® Marlin ACIF Cage System (K162402) [SolcoBiomedical Co., Ltd.] - Primary PredicatePATRIOT SPACERS: COLONIAL ACDF (K072991,Additional)TRYPTIK Ca (K091873, Additional)MATISSE Anterior Cervical Interbody Fusion CageSystem (K162682, Additional)
Description of Device	4CIS® Marlin PEEK ACIF Cage is single componentdevices used to restore height of disc space by anteriorapproach and to facilitate cervical interbody fusion withmaintaining physiological lordotic angulation of cervicalspine. To allow maximum preservation and ensure amplecontact surfaces with bony endplate, a variety of shapes andsizes are available and each device has three tantalummarkers for ease of visualization on radiographs. Thevertical square teeth on the top and the bottom surfaceprevent subsidence of the cage into the vertebral body whilethey increase the anchoring and prevent slipping orexpulsion. To make solid fusion of intervertebral body,hollow space in the implant allows bone graft material to befilled. The implant has safety proven structure and material(Poly-ether-ether-ketone, ASTM F2026) to promotebiological synostosis and assures mechanical safety againstload.
Indication for Use	4CIS® Marlin PEEK ACIF Cage is indicated for use incervical intervertebral body fusion procedures in skeletallymature patients with degenerative disc disease (DDD) at thelevels from the C2-C3 disc to the C7-T1 disc. DDD is definedas neck pain of discogenic origin with degeneration of the discconfirmed by patient history and radiographic studies. Thesepatients should have six weeks of non-operative therapy inadvance. The 4CIS® Marlin PEEK ACIF Cage is to be usedwith autogenous bone graft and/or allogenic bone graftcomprised of cancellous and/or corticocancellous bone graft,and is to be implanted via an open, anterior approach. It isintended to be used with supplemental spinal fixation systemsthat have been cleared for use in the cervical spine, such asAnterior Cervical Plate system.
Comparison ofTechnologicalCharacteristics withthe Predicate Devices	The subject device and all the predicates have the same orsimilar indications for use statements. The subject device iscomposed of the same material as the predicate devicesconforming to recognized industry standards for permanentimplants and surgical orthopedic instruments. All they havesimilar basic design features and functions as well as thosedimensions. The subject device and cited predicate devices areprovided non-sterile for single use only. The subject devicedemonstrated equivalent mechanical performance to the citedpredicate device under the same test conditions.
Performance Data	Mechanical testing (static axial compression, staticcompression-shear, static torsion, dynamic axial compression,dynamic compression-shear, dynamic torsion and staticsubsidence) was conducted in accordance with ASTM F2077-17 and F2267-04.Above non-clinical performance data in the form of acomprehensive literature review was provided in support ofsubstantial equivalence of the subject device.
Conclusion	The overall technology characteristics and mechanicalperformance data lead to the conclusion that the subject deviceis substantially equivalent to legally marketed predicatedevices.

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K192044
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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.