The Integrity Spine Lumbar Interbody Fusion is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

Device Description

The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) may be implanted:

bi-laterally in pairs via a posterior (PLIF) approach;
as a single device via an oblique (OLIF) approach:
as a single device via a transforaminal (TLIF) approach; or
as as a single device via an anterior or anterolateral (ALIF) approach.
The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
The 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.

AI/ML Overview

This document is a 510(k) premarket notification for the Integrity Spine Lumbar Interbody Fusion System. It is an FDA clearance letter and a 510(k) summary, not a study report proving a device meets acceptance criteria. As such, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, ground truth, or expert involvement for evaluating device performance in the context of AI or diagnostic accuracy studies.

The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and non-clinical mechanical testing for safety and performance in a physical device context (interbody fusion).

Therefore, I cannot extract the requested information from this document. The document discusses:

Device Name: Integrity Spine Lumbar Interbody Fusion System (Page 2)
Intended Use: Intervertebral body fusion of the lumbar spine, from L2 to S1, for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis, for skeletally mature patients who have had six months of non-operative treatment. (Page 2)
Testing: Non-clinical mechanical testing including static and dynamic compression, static and dynamic torsion, subsidence, and expulsion testing. These tests were conducted according to ASTM standards (F2077-11, F2267-04, and a Draft Standard F-04.25.02.02). (Page 5)
Conclusion: The device is substantially equivalent to predicate devices based on shared intended use, implant design, material, and non-clinical mechanical test results. (Page 5)

The prompt asks for acceptance criteria and study details that are typically found in studies evaluating diagnostic devices, AI algorithms, or clinical performance. This document pertains to a surgical implant and its mechanical properties.

Summary

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

November 10, 2015

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

Re: K151819

Trade/Device Name: Integrity Spine Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 12, 2015 Received: October 15, 2015

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

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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,

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) K151819

Device Name

Integrity Spine Lumbar Interbody Fusion System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary Integrity Spine Lumbar Interbody Fusion System Premarket Notification

SUBMITTED BY	Integrity Spine2800 NE Loop 410 Suite 203San Antonio, TX 78218
ESTABLISHMENTREGISTRATION NUMBER	3010763958
OWNER/OPERATORNUMBER	10046086
CONTACT PERSON	Lisa PetersonKaedon Consulting, LLCPhone: 512-507-0746Fax: 512-266-3364lpeterson@kaedonconsulting.com
DATE PREPARED	October 12, 2015
CLASSIFICATION NAME	Intervertebral Body Fusion Device
DEVICE CLASS	Class II
REGULATION NUMBER	21 CFR 888.3080 (Product Code MAX)
COMMON NAME	Intervertebral Fusion Device with Bone Graft, Lumbar
PROPRIETARY NAME	Integrity Spine Lumbar Interbody Fusion System

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IDENTIFICATION OF PREDICATE DEVICE(S)

Predicate devices include various cleared interbody fusion systems:

Primarv

DiFusion: Xiphos Interbody Fusion System (K100042) -

Secondary

Additional Predicate

DePuy Acromed: Lumbar I/F Cage (P960025) -

Reference Devices

Eminent Spine: Eminent Spine Interbody Fusion System । (K090064)
Medtronic: InterFix System (P970015) -
SeaSpine: SeaSpine Spacer System (K082310) -
Tyber Medical: Tyber Medical Interbody System -(K130573)
Spinal USA: Spinal USA Interbody Fusion Device -(K092193)

DEVICE DESCRIPTION

bi-laterally in pairs via a posterior (PLIF) approach;
as a single device via an oblique (OLIF) approach:
as a single device via a transforaminal (TLIF) approach; or
as as a single device via an anterior or anterolateral (ALIF) approach.

The 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

The Integrity Spine Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine. from L2 to S1. in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

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SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The purpose of this premarket notification is to obtain clearance to market the Integrity Spine Lumbar Interbody Fusion System. The Integrity Spine System is comprised of various device configurations based on surqical approach and patient anatomy. The 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 subject system has similar technological characteristics as the predicate devices identified above. Specifically, the following characteristics support this conclusion:

Intended for use at either one level or two contiquous levels, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
-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 Lumbar Interbody Fusion System is substantially equivalent to the predicate device.

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.