The INNESIS PEEK Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. INNESIS PEEK Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. INNESIS PEEK Cervical 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 INNESIS PEEK Cervical Cage is an implant for the anterior stabilization of the cervical spinal column using an Anterior Cervical Desectorny and Fusion (ACDF) surgery. The INNESIS PEEK Cervical Cages are offered in a variety of heights, footprints and curved shapes. The INNESIS PEEK Cervical Cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. The INNESIS PEEK Cervical Cage includes spikes and marker (pin) for radiological evaluation of the position and orientation of the radiolucent PEEK Cage

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the INNESIS PEEK Cervical Cage, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to predicate devices and the mechanical performance of the INNESIS PEEK Cervical Cage. The acceptance criteria are based on established ASTM standards for intervertebral body fusion devices.

Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Standard)	Reported Device Performance
Static Axial Compression	ASTM F2077-03	Testing conducted in accordance with standard. (Implied: Met requirements)
Dynamic Axial Compression	ASTM F2077-03	Testing conducted in accordance with standard. (Implied: Met requirements)
Static Compression Shear	ASTM F2077-03	Testing conducted in accordance with standard. (Implied: Met requirements)
Static Torsion	ASTM F2077-03	Testing conducted in accordance with standard. (Implied: Met requirements)
Dynamic Torsion	ASTM F2077-03	Testing conducted in accordance with standard. (Implied: Met requirements)
Static Subsidence	ASTM F2267-04	Testing conducted in accordance with standard. (Implied: Met requirements)
Expulsion	ASTM Draft Standard F04.25.02.02	Testing conducted in accordance with standard. (Implied: Met requirements)
Material Biocompatibility (PEEK)	ASTM F2026	PEEK (Polyetheretherketone) recognized as suitable biomaterial.
Material Biocompatibility (Titanium Alloy)	ASTM F136	Titanium Alloy (Ti6Al4V-ELI) recognized as suitable biomaterial.
Endotoxin Testing	Not explicitly stated	Demonstrated that the process does not introduce endotoxins.

Note: The document states "Testing results are for the following:" followed by the list of tests and standards. It then concludes by saying "These materials are both recognized as suitable biomaterials for this intended use and predicate devices have previously been cleared by FDA for this same intended use. Endotoxin testing has demonstrated that the process does not introduce endotoxins as a bi-product of the manufacturing and cleaning process." While it directly states biocompatibility and endotoxin results, for the mechanical tests, it implicitly suggests that the device met the requirements of the standards by stating testing was conducted in accordance with them, which is the typical approach for demonstrating substantial equivalence for mechanical properties.

Study Details

The provided text describes pre-clinical, often benchtop, testing rather than a clinical study. Therefore, some of the requested information regarding clinical study design (e.g., sample size for test sets, expert ground truth, MRMC studies) is not applicable.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified for individual tests. For mechanical testing of medical devices, samples are typically physical units of the device tested under controlled laboratory conditions.
- Data Provenance: Not explicitly stated, but implied to be from laboratory testing performed by BK Meditech Co, Ltd. or a contracted testing facility, likely in the Republic of Korea given the company's origin. The data is retrospective in the sense that it's generated for regulatory submission after device development.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the testing described is mechanical, material, and chemical (endotoxin) in nature, not based on expert interpretation of clinical data or images. The "ground truth" here is the adherence to the specified ASTM standards and the validated properties of the materials.
Adjudication method for the test set:
- Not applicable for the type of testing performed. Mechanical and material tests have objective pass/fail criteria based on quantitative measurements against a standard.
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 device is an implantable medical device (cervical cage), not an AI diagnostic or image interpretation tool. Therefore, no MRMC study or AI assistance is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm or AI.
The type of ground truth used:
- For mechanical, material, and chemical tests: The ground truth is the performance specification defined by recognized industry standards (ASTM) and accepted material properties for biomaterials. For endotoxin testing, the ground truth is the absence of endotoxins at or below detectable levels.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/machine learning model for this type of device submission. The device design and materials are based on established engineering principles and prior art (predicate devices), not machine learning.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/machine learning model. The analogous "ground truth" for the device's design and manufacturing is based on established engineering and materials science principles, industry standards, and the performance history of similar predicate devices.

Summary

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510(k) Summary

Submitted on behalf of:

Company Name: BK Meditech Co, Ltd Address: 215-5 Yodang-Li, Yanggam-Myun Hwasung-Si, Kyunggi-Do Republic of Korea 445-931 Telephone: 82-313529135 Fax: 82-313529134

by: Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 Telephone: 715-549-6035 Fax: 715-549-5380

CONTACT PERSON: Elaine Duncan DATE PREPARED: March 3, 2014 TRADE NAME: INNESIS PEEK CERVICAL CAGE COMMON NAME: Intervertebral body fusion device DEVICE CLASSIFICATION Class II CLASSIFICATION NAME: Orthosis, Intervertebral body fusion device, cervical REDUALTION: 888.3080 PRODUCT CODE: ODP

INDICATIONS FOR USE:

DESCRIPTION of the DEVICE:

SUBSTANTIALLY EQUIVALENCE DEMONSTRATED BY:

The subject and predicate devices are substantially equivalent in the areas of materials, design, indications for use and operational principles. Based on the comparison between the subject

APR 0 2 2014

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and predicate devices, BK MEDITECH Co., Ltd. believes that the INNESIS PEEK Cervical Cages are substantially equivalent (as fully detailed in the submission) to predicate devices which include the following devices:

Company Name	Device Tradename	510(k)Number
BK MEDITECH Co., Ltd	INNESIS PEEK CAGE(lumbar)	K120464
Stryker Spine	Stryker Spine AVS® AS PEEK Spacer	K120486
Southern Spine, LLC	Southern Spine C-Fuse™ CervicalIntervertebral Body Fusion System	K130948
SpineCraft, LLC	ORIO Intervertebral Body Fusion Cage by	K090887
Medacta International, SA	Mecta-C	K112862
Custom Spine	PATHWAY ACIF	K092904
Biomet Spine	C-Thru™ Anterior Spinal System	K092336
BM Korea	SYNSTER® CERVICAL CAGE	K111820
Medicrea Technologies	IMPIX cervical interbody device	K072226

SUMMARY of TESTING:

Testing results are for the following:

Static and dynamic axial compression test, conducted in accordance with ASTM F2077-03
Static compression shear test, conducted in accordance with ASTM F2077-03
Static and dynamic torsion test, conducted in accordance with ASTM F2077-03
Static subsidence test, conducted in accordance with ASTM F2267-04
Expulsion test, conducted in accordance with ASTM Draft Standard F04.25.02.02.

The material of the INNESIS PEEK Cervical Cage (permanent implant- long term) is PEEK (Polyetheretherketone, ASTM F2026) and Titanium Alloy (Ti6Al4V-ELI, ASTM F136). These materials are both recognized as suitable biomaterials for this intended use and predicate devices have previously been cleared by FDA for this same intended use. Endotoxin testing has demonstrated that the process does not introduce endotoxins as a bi-product of the manufacturing and cleaning process.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

April 2, 2014

BK Meditech Co., Ltd. % Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Incorporated P.O. Box 560 Stillwater, Minnesota 55082

Re: K132483

Trade/Device Name: INNESIS PEEK Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 3, 2014 Received: March 4, 2014

Dear Ms. Duncan:

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 11 (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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 -Elaine Duncan, MS.ME. RAC

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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 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.

Ronald®P:Jean -S for

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) K132483

Device Name INNESIS PEEK CERVICAL CAGE

Indications for Use (Describe)

The INNESIS PEEK Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-TI). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. INNESIS PEEK Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are ior approach and packed with autogenous bone. INNESIS PEEK Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

Production of the Production of the FOR FOR FOR FOR FOR FOR CONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Anton E. Dmitriev, PhD

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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.