The AnyPlus® Cervical 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. AnyPlus® Cervical PEEK cages are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. AnyPlus® Cervical PEEK cages are 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

The AnyPlus® Cervical PEEK Cage System is designed for restoring the height of the intervertebral space after resection of the disc. AnyPlus® Cervical PEEK Cage System 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® Cervical PEEK Cage System are radiolucent allowing X-ray visualization to verify device placement. AnyPlus® Cervical PEEK Cage System is supplied non-sterile and is intended for single use only. AnyPlus® Cervical PEEK Cage System is designed for interbody stabilization of the cervical spine.

AI/ML Overview

The provided text describes the 510(k) summary for the "AnyPlus® Cervical PEEK Cage System," which is a medical device for spinal fusion. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.

However, I can extract the relevant information from the provided text as if the non-clinical testing served as the "study" for this type of medical device's performance acceptance.

Here's the breakdown based on your request, interpreting "acceptance criteria" as meeting performance standards and "study" as the non-clinical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Standard)	Reported Device Performance
ASTM 2077-11: Static Axial Compression	All performance test results were equivalent to or higher than a legally marketed predicate device.
ASTM 2077-11: Dynamic Axial Compression	All performance test results were equivalent to or higher than a legally marketed predicate device.
ASTM 2077-11: Static Compression-Shear	All performance test results were equivalent to or higher than a legally marketed predicate device.
ASTM 2077-11: Dynamic Compression-Shear	All performance test results were equivalent to or higher than a legally marketed predicate device.
ASTM 2077-11: Static Torsion	All performance test results were equivalent to or higher than a legally marketed predicate device.
ASTM 2077-11: Dynamic Torsion	All performance test results were equivalent to or higher than a legally marketed predicate device.
ASTM 2077-11: Expulsion Testing	All performance test results were equivalent to or higher than a legally marketed predicate device.
ASTM F2267-04: Static Subsidence (Axial Compression)	All performance test results were equivalent to or higher than a legally marketed predicate device.

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

The document does not specify a "sample size" in terms of patient data or clinical cases for a test set. This is a non-clinical study. The "test set" refers to the physical devices tested according to the ASTM standards. The specific number of devices tested for each standard is not provided in this summary.

Data Provenance: The testing was non-clinical, involving physical devices in a laboratory setting. Therefore, there's no country of origin for "data" in the sense of patient data, nor is it retrospective or prospective. It's a laboratory-based evaluation of device mechanics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. For non-clinical, mechanical testing of a medical implant, "ground truth" is established by the specified ASTM test method and engineering principles, not by expert consensus on clinical findings. The results are objective measurements of physical properties.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "test set" involves objective mechanical testing against engineering standards, not subjective interpretations requiring adjudication.

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 document pertains to a physical medical implant (a cervical PEEK cage system), not an AI/ML device for diagnostic imaging or similar applications where human readers' performance would be evaluated. No such study was conducted or is relevant to this submission.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is derived from the established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices. These standards define the mechanical performance requirements and test methodologies. The device's performance measured against these objective, standardized tests serves as the ground truth for its mechanical properties.

8. The Sample Size for the Training Set

Not applicable. This is a non-clinical submission for a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable for the same reasons as #8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profile graphic.

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

June 24, 2016

GS Medical Company, Ltd. % Mr. Barry E. Sands President RQMIS, Incorporated 29 Water Street, Suite 305 Newburyport, Massachusetts 01950

Re: K153517

Trade/Device Name: AnyPlus® Cervical PEEK Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: May 26, 2016 Received: May 27, 2016

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. 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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

forth in the quality systems (QS) 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" (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,

Lori A. Wiggins -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K153517

Device Name AnyPlus® Cervical 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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

GS Medical Co., Ltd.

AnyPlus® Cervical PEEK Cage System

Manufacturer:	GS Medical Co., Ltd.90, Osongsaengmyeong 4-roOsong-eupCheongwon-gunChungcheongbuk-do363-951 Korea
Date:	March 20, 2016
Submitted by:	GS Medical Co., Ltd
Company Contact	Marcin Niemiec
US Agent InformationOfficial Correspondent	RQMIS Inc.Mr. Barry E. Sands110 Haverhill Road, Suite 526Amesbury, MA 01913Ph: 978-358-7307www.rqmis.com
Proprietary Name:	AnyPlus® Cervical PEEK Cage System
Performance standards:	The AnyPlus® Cervical PEEK Cage System was non-clinically testedaccording to the ASTM 2077-11 and ASTM F2267-04 performancestandards.
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 AnyPlus® Cervical PEEK Cage System isbased on its similarities in indications for use, design features,operational principles and material composition when compared to thepredicate devices.
Predicate Devices:	K082801 US Spine Phantom Cervical Cage (primary)K091873 SpineArt Tryptik Cervical Cage (secondary)
	The subject device is substantially equivalent to similar previouslycleared devices.

{4}------------------------------------------------

Device Description:	The AnyPlus® Cervical PEEK Cage System is designed for restoring theheight of the intervertebral space after resection of the disc. AnyPlus®Cervical PEEK Cage System consists of implants available in variousheights and lordotic configurations with an open architecture to acceptpacking of bone graft material. The intervertebral body fusion devicesare made of poly-ether-ether-ketone (PEEK Optima LT1) body with theX-ray (radio-opaque) markers made of Tantalum. The AnyPlus® CervicalPEEK Cage System are radiolucent allowing X-ray visualization to verifydevice placement. AnyPlus® Cervical PEEK Cage System is supplied non-sterile and is intended for single use only. AnyPlus® Cervical PEEK CageSystem is designed for interbody stabilization of the cervical spine.
Intended Use:	The AnyPlus® Cervical PEEK Cage System is indicated for use inskeletally mature patients with degenerative disc disease (DDD) of thecervical spine with accompanying radicular symptoms at one disc level.DDD is defined as discogenic pain with degeneration of the discconfirmed by patient history and radiographic studies. AnyPlus®Cervical PEEK cages are used to facilitate intervertebral body fusion inthe cervical spine at the C3 to C7 disc levels using autograft bone.AnyPlus® Cervical PEEK cages are to be used with supplemental fixation.Patients should have at least six (6) weeks of non-operative treatmentprior to treatment with an intervertebral cage.
Summary of TechnologicalCharacteristics	The AnyPlus® Cervical PEEK cages are designed for restoring the heightof the intervertebral space after resection of the disc. The AnyPlus®Cervical PEEK cages consist of implants available in various heights andlordotic configurations with an open architecture to accept packing ofbone graft material. The implants are made of polyether-ether-ketone(PEEK) body with the x-ray markers made of Tantalum. The intendeduse, technological characteristics, mode of action and materials ofconstruction are the same as those of the referenced predicate devices
Non-Clinical Testing	The AnyPlus® Cervical PEEK cages were tested according to the ASTM2077, specifically, Static and Dynamic Axial Compression, Static andDynamic Compression-Shear Testing, Static and Dynamic TorsionTesting Expulsion Testing and Static Subsidence testing under AxialCompression, per ASTM 2267. All performance test results wereequivalent to or higher than a legally marketed predicate device.
Clinical Testing	No clinical testing was performed.
Conclusion	The AnyPlus® Cervical PEEK cages have the same intended use andsimilar indications, principles of operation, and technologicalcharacteristics as the predicate devices. The minor differences in thedesigns do not raise any new questions of safety or effectiveness.Performance data demonstrates that the AnyPlus® Cervical PEEK cagesare as safe and effective as the predicate devices. Thus, the AnyPlus®Cervical PEEK cages are substantially equivalent to the predicatedevices.

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.