The GS Medical AnyPlus® PEEK 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. GS Medical AnyPlus® PEEK Cage System are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical AnyPlus® PEEK Cage System are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

Device Description

The GS Medical AnyPlus® PEEK Cage System device is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® PEEK Cage System device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The intervertebral body fusion devices are made of poly-ether-ether- ketone (PEEK Optima LT1) body with the X-ray (radio-opaque) markers made of Tantalum. The AnyPlus® PEEK Cage System devices are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® PEEK Cage System device is supplied sterile and non-sterile and is intended for single use only. AnyPlus® PEEK Cage System is designed for interbody stabilization of the cervical spine.

AI/ML Overview

The provided text describes a medical device, the GS Medical AnyPlus® PEEK Cage System, for which FDA 510(k) clearance was sought. It details the device's intended use, technological characteristics, and non-clinical testing.

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

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Set by ASTM Standards)	Reported Device Performance
Static and Dynamic Axial Compression	Met or exceeded requirements for a legally marketed predicate device
Static and Dynamic Compression-Shear Testing	Met or exceeded requirements for a legally marketed predicate device
Static and Dynamic Torsion Testing	Met or exceeded requirements for a legally marketed predicate device
Expulsion Testing	Met or exceeded requirements for a legally marketed predicate device
Static Subsidence testing under Axial Compression (per ASTM F2267)	Met or exceeded requirements for a legally marketed predicate device
Pyrogen limit specifications	Met specifications on "worst-case" model, complying with FDA guidance

2. Sample size used for the test set and the data provenance

The document mentions non-clinical testing according to ASTM standards. It does not provide specific sample sizes for these tests, nor does it detail the provenance of any data beyond indicating "worst-case" models for pyrogen testing. There is no human patient data or a "test set" in the traditional sense for evaluating diagnostic or predictive performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable (N/A) as the device is a spinal fusion cage and underwent non-clinical performance testing, not a study requiring expert-established ground truth for diagnostic accuracy.

4. Adjudication method for the test set

This information is not applicable (N/A) for the same reason as point 3.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed." The device did not involve human readers or AI assistance.

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

No, this device is a physical medical implant (spinal cage), not an algorithm or AI system. Therefore, standalone algorithm performance testing is not applicable (N/A).

7. The type of ground truth used

The "ground truth" for this device's performance was established through engineering and material science standards (ASTM 2077-11 and ASTM F2267-04). These standards define the acceptable mechanical and material properties for intervertebral body fusion devices.

8. The sample size for the training set

This information is not applicable (N/A). This product is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable (N/A) for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

August 10, 2020

GS Medical Co., Ltd. % Mr. Barry Sands President and Founder RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, Massachusetts 01913

Re: K200592

Trade/Device Name: The GS Medical AnyPlus® PEEK Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: July 10, 2020 Received: July 15, 2020

Dear Mr. Sands:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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 Showalter, Ph.D. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200592

Device Name GS Medical AnyPlus® PEEK 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

GS Medical Co., Ltd.

AnyPlus® PEEK Cage System

Manufacturer:	GS Medical Co.,Ltd.90, Osongsaengmyeong 4-roOsong-eupCheongwon-gunChungcheongbuk-do363-951 Korea
Date:	March 2, 2020
Submitted by:	GS Medical Co.,Ltd
Company Contact	Andrea Watt+1 949-380-6385awatt@gsmedical.com
US Agent InformationOfficial Correspondent	RQMIS Inc.Mr. Barry E. Sands110 Haverhill Rd, Suite 526Amesbury, MA 01913Ph: 978-358-7307barrysands@rqmis.com
Proprietary Name:	The GS Medical AnyPlus® PEEK Cage System
Performance standards:	The GS Medical AnyPlus® PEEK Cage System was non-clinically tested according to the ASTM 2077-11 and ASTMF2267-04 performance standards.
Regulation:Common/Usual Name:Classification name:Review Panel:Product Code:Device Class:	21 CFR 888.3080Cervical Spinal Fusion Device, IBF DeviceIntervertebral body fusion device - CervicalOrthopedicODPClass II
Substantial Equivalence:	Substantial equivalence for the GS Medical AnyPlus® PEEKCage System is based on its similarities in indications for use,design features, operational principles and materialcomposition when compared to the predicate devices.
Primary Predicate Device:	K153517 GS Medical AnyPlus® Cervical PEEK CageThe subject device is substantially equivalent to similar previously cleared devices.
Device Description:	The GS Medical AnyPlus® PEEK Cage System device is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® PEEK Cage System device consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The intervertebral body fusion devices are made of poly-ether-ether- ketone (PEEK Optima LT1) body with the X-ray (radio-opaque) markers made of Tantalum. The AnyPlus® PEEK Cage System devices are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® PEEK Cage System device is supplied sterile and non-sterile and is intended for single use only. AnyPlus® PEEK Cage System is designed for interbody stabilization of the cervical spine.
Intended Use:	The GS Medical AnyPlus® PEEK 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. GS Medical The GS Medical AnyPlus® PEEK Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. GS Medical The GS Medical AnyPlus® PEEK 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.
Summary of TechnologicalCharacteristics	The GS Medical AnyPlus® PEEK Cage System devices are designed for restoring the height of the intervertebral space after resection of the disc. The GS Medical AnyPlus® PEEK Cage System device consist of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The implants are made of polyether-ether- ketone (PEEK) body with the x-ray markers made of Tantalum. The intended use, technological characteristics, mode of action and materials of construction are the same as those of the referenced predicate devices.
Device Materials	Material	Standard
	Polyether-ether-ketone (PEEK)	ASTM F2026:17
	Unalloyed Tantalum	ASTM F560-17
	Wrought Stainless Steel	ASTM F899-19
Non-Clinical Testing	The GS Medical AnyPlus® PEEK Cage System devices weretested according to the ASTM 2077, specifically, Static andDynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing ExpulsionTesting and Static Subsidence testing under AxialCompression, per ASTM 2267. All performance test resultswere equivalent to or higher than a legally marketed predicatedevice. Pyrogen limit specifications were tested and met on"worst-case" model, complying with FDA guidance anspecifications.
Clinical Testing	No clinical testing was performed.
Conclusion	The GS Medical AnyPlus® PEEK Cage System has the sameintended use and similar indications, principles of operation,and technological characteristics as the predicate device. Theminor differences in the designs do not raise any newquestions of safety or effectiveness. Performance datademonstrates that the AnyPlus® Cervical PEEK Cage Systemare as safe and effective as the predicate device. Thus, theAnyPlus® Cervical PEEK Cage System is substantiallyequivalent to the predicate device.

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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.