When used as a cervical intervertebral body fusion device, the Integrity Spine Core System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

Device Description

The Integrity Spine Core System is a cervical intervertebral body fusion system comprised of parallel and lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.

The Integrity Spine Core System implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.

The Integrity Spine Core System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for the Integrity Spine Core System, an intervertebral body fusion device. The focus of this submission is to demonstrate substantial equivalence to previously cleared predicate devices through non-clinical mechanical testing, rather than a clinical study evaluating device performance in humans.

Therefore, many of the requested items related to clinical study design, such as acceptance criteria based on human performance, sample size for test sets (in a clinical context), expert ground truth establishment for diagnostic performance, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable to this 510(k) submission.

This submission primarily relies on bench testing to show mechanical equivalence.

Here's the information that can be extracted and a clear indication of what is not applicable:

1. Table of acceptance criteria and the reported device performance

Test Type	Acceptance Criteria (Implicit)	Reported Device Performance
Static and dynamic compression testing (ASTM F2077-11)	Performance comparable to predicate devices	Substantially equivalent results
Static and dynamic torsion testing (ASTM F2077-11)	Performance comparable to predicate devices	Substantially equivalent results
Subsidence testing (ASTM F2267-04)	Performance comparable to predicate devices	Substantially equivalent results
Expulsion testing (ASTM Draft Standard F-04.25.02.02)	Performance comparable to predicate devices	Substantially equivalent results

Explanation of Acceptance Criteria: The acceptance criteria for this 510(k) submission are implicitly defined as demonstrating "substantially equivalent results" in non-clinical mechanical testing compared to the identified predicate devices. This means the Integrity Spine Core System's mechanical performance in these standardized tests must fall within expected ranges relative to the predicates, indicating no new questions of safety or effectiveness are raised.

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

Sample Size for Test Set: Not applicable in the context of human data. For the mechanical tests, the sample sizes would be determined by the ASTM standards (e.g., number of constructs tested for compression, torsion, subsidence, and expulsion). The document does not specify these exact numbers, but it states the tests were "conducted in accordance with" the respective ASTM standards.
Data Provenance: Not applicable as this submission is based on non-clinical (bench) testing, not human data. The tests were performed in a lab setting to assess the device's physical properties.

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

Not Applicable. Ground truth, in the sense of expert diagnosis or outcome labeling from human data, is not established for this type of non-clinical mechanical testing. The "ground truth" here is the adherence to mechanical performance standards and comparison to predicate devices.

4. Adjudication method for the test set

Not Applicable. This is relevant for studies involving human data where there might be disagreements in interpretation (e.g., reading medical images). For mechanical testing, outcomes are typically measured objectively based on physical properties.

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 device is an intervertebral body fusion device, not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant.

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

Not Applicable. This is a physical medical implant, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable / Bench Test Standards. The "ground truth" for this submission are the established ASTM standards for mechanical testing of spinal implants (F2077-11 for static and dynamic mechanical testing, F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion) and the performance characteristics of the predicate devices. The aim is to demonstrate that the new device performs equivalently in these controlled mechanical environments.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of this 510(k) submission for a physical implant device. This concept applies to machine learning algorithms.

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

Not Applicable. As there is no training set, there is no corresponding ground truth to establish.

Summary

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NOV 1 8 2013

510(k) Summarv Integrity Spine Core System Premarket Notification

SUBMITTED BY

Integrity Spine 2800 NE Loop 410 Suite 203 San Antonio, TX 78218

ESTABLISHMENT REGISTRATION NUMBER

Pending

OWNER/OPERATOR
NUMBER

CONTACT PERSON

Pending

Lisa Peterson
Kaedon Consulting, LLC
Phone: 512-507-0746
Fax: 512-266-3364
lpeterson@kaedonconsulting.com

DATE PREPARED

August 28, 2013

Intervertebral Body Fusion Device

DEVICE CLASS

REGULATION NUMBER

CLASSIFICATION NAME

COMMON NAME

PROPRIETARY NAME

IDENTIFICATION OF PREDICATE DEVICE(S)

Class II

888.3080 (Product Code ODP)

Intervertebral Fusion Device with Bone Graft, Cervical

Integrity Spine Core System

Predicate devices include various cleared interbody fusion systems:

Zimmer Spine: BAK/C (P980048) -
LDR Spine: MC+ (K043479, K091088) ı
Eminent Spine: Eminent Spine Interbody Fusion System -(K090064)
SpineNet, LLC: Daytona Anterior Cervical Cage -(K110733)

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DEVICE DESCRIPTION

The Integrity Spine Core System is a cervical interbody fusion system comprised of parallel and lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.

The Integrity Spine Core System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

INDICATIONS

When used as a cervical intervertebral body fusion device, the Integrity Spine Core System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-TI disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The purpose of this premarket notification is to obtain clearance to market the Integrity Spine Core System. The Integrity Spine Core System is comprised of parallel and lordotic cages in two footorints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach.

The subject system has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion:

Intended for use at one level from the C2-C3 disc to the C7-TI disc for the treatment of degenerative disc disease (DDD) of the cervical spine with accompanying radicular svmptoms.
-Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Substantially equivalent results of non-clinical testing relative to static and dynamic testing -(per ASTM F2077-11 ), subsidence (per ASTM F2267-04), and expulsion (per ASTM Draft Standard F-04.25.02.02)

DISCUSSION OF NON-CLINICAL TESTING

The following non-clinical tests were conducted:

-Static and dynamic compression testing, conducted in accordance with ASTM F2077-11
-Static and dynamic torsion testing, conducted in accordance with ASTM F2077-11
Subsidence testing, conducted in accordance with ASTM F2267-04 -
-Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02

CONCLUSIONS

The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Integrity Spine Core System is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three abstract shapes that resemble human figures or flowing forms. The logo is printed in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

November 18, 2013

Integrity Spine % Ms. Lisa Peterson Principal Consultant Kaedon Consulting, LLC 14001 Hunters Pass Austin, Texas 78734

Re: K132718

Trade/Device Name: Integrity Spine Core System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: August 29, 2013 Received: August 30, 2013

Dear Ms. Peterson:

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 Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Lisa Peterson

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 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" (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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson -S

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): K132718

Device Name: Integrity Spine Core System

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices

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.