GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF) by GS MEDICAL CO., LTD.

AnyPlus® PEEK Lumbar Fusion Cage device is intended for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

Device Description

The GS Medical AnyPlus PEEK Lumbar Cage device consists 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 OPTIMA LT1) (Manufacturer - INVIBIO) body with the x-ray markers made of Titanium alloy (Ti-6Al-4V). This submission includes the addition of sizes to the model ALIF devices and a revision of the shapes of the TLIF model and the PLIF model to accommodate surgeons using a Direct Lateral Interbody Fusion (DLIF) surgical approach.

AI/ML Overview

The provided text describes the 510(k) summary for the GS Medical AnyPlus PEEK Lumbar Fusion Cage. It details the device's characteristics, intended use, and the non-clinical testing conducted to demonstrate substantial equivalence to predicate devices. However, the document does not describe a study involving a test set, human readers, or an AI algorithm.

Instead, the submission focuses on non-clinical performance standards for an intervertebral body fusion device. Therefore, many of the requested points regarding acceptance criteria and studies are not applicable in this context.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on demonstrating mechanical performance and safety, primarily through non-clinical testing in accordance with established ASTM (American Society for Testing and Materials) standards. The "device performance" reported is that the device met these standards.

Acceptance Criteria (ASTM Standard)	Reported Device Performance
ASTM F2077-03: - Static Axial Compression	Tested according to ASTM F2077-03 and ASTM F2267-04. Demonstrated compliance with specific tests including: - Static and Dynamic Axial Compression - Static and Dynamic Compression-Shear Testing - Static and Dynamic Torsion Testing
- Dynamic Axial Compression
- Static Compression-Shear Testing
- Dynamic Compression-Shear Testing
- Static Torsion Testing
- Dynamic Torsion Testing
ASTM F2267-04: - Expulsion Testing	- Expulsion Testing - Static Subsidence testing under Axial Compression
- Static Subsidence Testing under Axial Compression
Overall Goal: Substantial equivalence to predicate devices in terms of performance and safety for intended use.	"The information discussed above demonstrates requested changes to the GS Medical PEEK Lumbar Cage device is effective and performs as well as or better than the predicate devices."

Study Details (Applicable points from the Request)

Since this is a non-clinical, mechanical performance study of an implantable device, most of the requested points related to AI, human readers, and ground truth establishment in a diagnostic context are not relevant or present in this document.

Sample size used for the test set and the data provenance:
- This document describes non-clinical laboratory testing of the device itself (e.g., mechanical strength, durability), not a "test set" of patient data. The "sample size" would refer to the number of devices tested in the lab for each specific test, which is not detailed in this summary.
- Data provenance: Not applicable in the sense of patient data. The "data" comes from mechanical testing performed on the fabricated devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" in the diagnostic sense for this type of non-clinical device testing. Performance is evaluated against engineering standards (ASTM F2077, ASTM F2267).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human adjudication of clinical data.
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 is for a physical medical implant, not an AI-powered diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device. The "standalone performance" is the mechanical performance of the implant itself under specified test conditions.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the clinical sense. The "ground truth" for this device's performance is compliance with the specified ASTM mechanical testing standards and comparison to the predicate device's known performance.
The sample size for the training set:
- Not applicable. This is not an AI/algorithm-based device requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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K 111354

OCT 1 7 2011

6. 510(k) Summary

Manufacturer:	GS Medical Co. Ltd.12F Kolon Digital Tower Aston,505-14 Gasan-DongGeumcheon-gu, Seoul, Korea
Date:	October 14, 2011
Submitted by:	GS Medical Co. Ltd
Company Contact	Dong Young Kim+82-2-2082-777+82-2-2082-7778 (FAX)
US Agent Information	Orgenix LLCMr. Donald W. Guthner111 Hill RoadDouglassville, PA 19518+1-646-460-2984+1-484-363-5879 (FAX)
Classification Name:	Intervertebral Body Fusion Device
Common/Usual Name:	Intervertebral Body Fusion Device, IBF Device
Proprietary Name:	AnyPlus PEEK ALIF Lumbar Fusion CageAnyPlus PEEK DLIF Lumbar Fusion Cage
Performance standards:	The GS Medical AnyPlus PEEK Lumbar Cage was non-clinicallytested according to the ASTM 2077-03 and ASTM F2267-04performance standards.
Classification no .:	21 CFR 888.3080MAX - Intervertebral body fusion deviceClass II
Substantial Equivalence:	Substantial equivalence for the GS Medical AnyPlus PEEKLumbar Cage is based on its similarities in indications for use,design features, operational principles and material compositionwhen compared to the predicate devices cleared under thefollowing submissions:. K100516 AnvPluc DEEK Lumber Cago

• K100516 AnyPlus PEEK Lumbar Cage

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The subject device is substantially equivalent to similar previously Predicate Devices: cleared devices.

Device Description: The GS Medical AnyPlus PEEK Lumbar Cage device consists 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 OPTIMA LT1) (Manufacturer - INVIBIO) body with the x-ray markers made of Titanium alloy (Ti-6Al-4V). This submission includes the addition of sizes to the model ALIF devices and a revision of the shapes of the TLIF model and the PLIF model to accommodate surgeons using a Direct Lateral Interbody Fusion (DLIF) surgical approach.

Intended Use: The AnyPlus PEEK Lumbar Cage is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic These patients should have had six months of nonstudies. operative treatment. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

Summary of The GS Medical AnyPlus PEEK Lumbar Cage devices are designed for restoring the height of the intervertebral space after Technological resection of the disc. The AnyPlus PEEK Lumbar Cage devices Characteristics 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 Titanium alloy (Ti-6Al-4V). The intended use, technological characteristics, mode of action and materials of construction are the same as those of the referenced predicate devices

Non-Clinical Testing The GS Medical AnyPlus PEEK Lumbar Cage devices were tested according to the ASTM 2077, specifically, Static and Dynamic Axial Compression, Static and Dynamic Compression-Shear Testing, Static and Dynamic Torsion Testing Expulsion Testing and Static Subsidence testing under Axial Compression, per ASTM 2267.

Conclusion The information discussed above demonstrates requested changes to the GS Medical PEEK Lumbar Cage device is effective and performs as well as or better than the predicate devices.

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Image /page/2/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of an eagle or bird in flight, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN..." are arranged around the left side of the emblem in a circular fashion.

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

OCT 1 7 2011

GS Medical Co., Ltd. % Orgenix LLC Mr. Donald W. Guthner 111 Hill Road Douglassville, Pennsylvania 19518 ﺮ ﺍﻟ

Re: K111354

Trade/Device Name: GS Medical AnyPlus PEEK Lumbar Fusion Cages Regulation Number: 21 CFR 888.3080 . Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 19, 2011 Received: September 21, 2011

Dear Mr. Guthner:

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

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Page 2 - Mr. Donald W. Guthner

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

Erine Keith

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

Enclosure

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5. Indications for Use

510(k) Number (if known): K111354

Device Name: GS Medical AnyPlus PEEK Lumbar Fusion Cages

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KII 354 510(k) Number_

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.